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PI terminated study due to lack of resources.
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Low-level laser therapy (LLLT) is a well-studied technique that has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. This study will use two groups with patients randomly assigned to either the study group, receiving LLLT, or one receiving a placebo treatment, after they have lower jaw surgery. Measurements will be taken at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams to check pain, swelling and nerve function, and the two groups will be compared to see if the LLLT group has any difference
Low-level laser therapy (LLLT) is a well-studied technique to induce biomodulation of pain and wound healing. The technique has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. Previous studies have used split-mouth designs, short follow-up periods or, often, both. This study aims to have two groups, one receiving LLLT and one receiving a dummy treatment, at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams. At each visit, pain (via VAS), swelling (measured from the midpoint of the chin to the base of the ear, bilaterally), and nerve function (using a soft and hard sensory test, in 8 regions of the mandible and lower lip) will be performed, with additional measurements at 8 weeks and 20 weeks. The measurements will be analyzed for statistical differences between the LLLT intervention group and non-intervention group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-level therapy intervention | Experimental | Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine. |
|
| dummy intervention | Placebo Comparator | Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-level laser therapy | Device | The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 24 hours post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 1 week post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 2 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Levine, DMD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center, Department of Dentistry and Oral Surgery | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20613608 | Background | D'Agostino A, Trevisiol L, Gugole F, Bondi V, Nocini PF. Complications of orthognathic surgery: the inferior alveolar nerve. J Craniofac Surg. 2010 Jul;21(4):1189-95. doi: 10.1097/SCS.0b013e3181e1b5ff. | |
| 33358708 | Background | Haghighat A, Khosrawi S, Tamizifar A, Haghighat M. RETRACTED: Does Low-Level Laser Photobiomodulation Improve Neurosensory Recovery After Orthognathic Surgery? A Clinical Trial With Blink Reflex. J Oral Maxillofac Surg. 2021 Mar;79(3):685-693. doi: 10.1016/j.joms.2020.11.025. Epub 2020 Nov 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-level Therapy Intervention | Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine. Low-level laser therapy (LLLT): The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| FG001 | Sham Intervention | Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine. Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-level Therapy Intervention | Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine. Low-level laser therapy (LLLT): The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, cotton swab samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for soft stimuli results data to report. | Posted | 24 hours post-surgery |
Adverse events were collected up to 8 weeks post-surgical intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-level Therapy Intervention | Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine. Low-level laser therapy (LLLT): The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy P. Levine, DMD | Albert Einstein College of Medicine | 718-918-5635 | timothy.levine@nychhc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2022 | Jun 20, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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intervention vs placebo
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Patients and outcomes assessor will be blinded to which group participants belong to.
|
| Dummy LLLT | Device | The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
|
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. |
| 3 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 4 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 5 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 6 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 8 weeks post-surgery |
| Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | 20 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 24 hours post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 1 week post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 2 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 3 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 4 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 5 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 6 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 8 weeks post-surgery |
| Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 20 weeks post-surgery |
| 24 hours post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 1 week post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 2 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 3 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 4 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 5 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 6 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 8 weeks post-surgery |
| Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 20 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 24 hours post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 1 week post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 2 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 3 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 4 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 5 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 6 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 8 weeks post-surgery |
| Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 20 weeks post-surgery |
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| 24679851 | Background | Gasperini G, Rodrigues de Siqueira IC, Rezende Costa L. Does low-level laser therapy decrease swelling and pain resulting from orthognathic surgery? Int J Oral Maxillofac Surg. 2014 Jul;43(7):868-73. doi: 10.1016/j.ijom.2014.02.015. Epub 2014 Mar 25. |
| 8863301 | Background | Khullar SM, Emami B, Westermark A, Haanaes HR. Effect of low-level laser treatment on neurosensory deficits subsequent to sagittal split ramus osteotomy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Aug;82(2):132-8. doi: 10.1016/s1079-2104(96)80215-0. |
| 33331972 | Background | Firoozi P, Keyhan SO, Kim SG, Fallahi HR. Effectiveness of low-level laser therapy on recovery from neurosensory disturbance after sagittal split ramus osteotomy: a systematic review and meta-analysis. Maxillofac Plast Reconstr Surg. 2020 Dec 17;42(1):41. doi: 10.1186/s40902-020-00285-0. |
| 31360374 | Background | Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25. |
| 16480503 | Background | Ozen T, Orhan K, Gorur I, Ozturk A. Efficacy of low level laser therapy on neurosensory recovery after injury to the inferior alveolar nerve. Head Face Med. 2006 Feb 15;2:3. doi: 10.1186/1746-160X-2-3. |
| 32181610 | Background | Esteves Pinto Faria P, Temprano A, Piva F, Sant'ana E, Pimenta D. Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy. Minerva Stomatol. 2020 Jun;69(3):141-147. doi: 10.23736/S0026-4970.20.04289-2. Epub 2020 Mar 16. |
| 29053658 | Background | Bittencourt MA, Paranhos LR, Martins-Filho PR. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials. Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):780-787. doi: 10.4317/medoral.21968. |
| 29264287 | Background | Hamid MA. Low-level Laser Therapy on Postoperative Pain after Mandibular Third Molar Surgery. Ann Maxillofac Surg. 2017 Jul-Dec;7(2):207-216. doi: 10.4103/ams.ams_5_17. |
| 17448510 | Background | Boutault F, Diallo R, Marecaux C, Modiga O, Paoli JR, Lauwers F. [Neurosensory disorders and functional impairment after bilateral sagittal split osteotomy: role of the anatomical situation of the alveolar pedicle in 76 patients]. Rev Stomatol Chir Maxillofac. 2007 Jun;108(3):175-82; discussion 182. doi: 10.1016/j.stomax.2006.11.006. Epub 2007 Apr 19. French. |
| 15741031 | Background | Al-Bishri A, Barghash Z, Rosenquist J, Sunzel B. Neurosensory disturbance after sagittal split and intraoral vertical ramus osteotomy: as reported in questionnaires and patients' records. Int J Oral Maxillofac Surg. 2005 May;34(3):247-51. doi: 10.1016/j.ijom.2004.06.009. |
| 15573346 | Background | Al-Bishri A, Rosenquist J, Sunzel B. On neurosensory disturbance after sagittal split osteotomy. J Oral Maxillofac Surg. 2004 Dec;62(12):1472-6. doi: 10.1016/j.joms.2004.04.021. |
| 15165389 | Background | Reddy GK. Photobiological basis and clinical role of low-intensity lasers in biology and medicine. J Clin Laser Med Surg. 2004 Apr;22(2):141-50. doi: 10.1089/104454704774076208. |
| 23265759 | Background | Kuroyanagi N, Miyachi H, Ochiai S, Kamiya N, Kanazawa T, Nagao T, Shimozato K. Prediction of neurosensory alterations after sagittal split ramus osteotomy. Int J Oral Maxillofac Surg. 2013 Jul;42(7):814-22. doi: 10.1016/j.ijom.2012.11.016. Epub 2012 Dec 21. |
| 21763047 | Background | Baas EM, Horsthuis RB, de Lange J. Subjective alveolar nerve function after bilateral sagittal split osteotomy or distraction osteogenesis of mandible. J Oral Maxillofac Surg. 2012 Apr;70(4):910-8. doi: 10.1016/j.joms.2011.02.107. Epub 2011 Jul 16. |
| 13452398 | Background | TRAUNER R, OBWEGESER H. The surgical correction of mandibular prognathism and retrognathia with consideration of genioplasty. II. Operating methods for microgenia and distoclusion. Oral Surg Oral Med Oral Pathol. 1957 Aug;10(8):787-92; contd. No abstract available. |
| BG001 | Sham Intervention | Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine. Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Inferior Alveolar Nerve (IAN) Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes(+) or No(-) response. The number of patients who responded Yes is summarized. | Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm. | Count of Participants | Participants |
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| Inferior Alveolar Nerve (IAN) Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized. | Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm. | Count of Participants | Participants |
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| Pre-Operative Pain | Pre-operative pain at baseline was reported via a Visual Analog Scale (VAS) response on the questionnaire. Using the VAS, patients rated the intensity of the pain on each side of the mandible (right and left). Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm. | Mean | Standard Deviation | score on a scale |
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| Pre-Operative Mandibular Swelling | Pre-operative mandibular swelling was measured using soft measuring tape. The extent of pre-operative swelling at baseline was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm. | Mean | Standard Deviation | millimeters |
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| OG000 | Low-level Therapy Intervention | Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine. Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
| OG001 | Sham Intervention | Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine. Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Swab samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit. | Posted | Count of Participants | Participants | 1 week post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Swab samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of regions R4 and L4 in which swab samples were able to be collected from 8 of 9 patients who attended their Week 2 visit. | Posted | Count of Participants | Participants | 2 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit. | Posted | Count of Participants | Participants | 3 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit. | Posted | Count of Participants | Participants | 4 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Swab samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit. | Posted | Count of Participants | Participants | 5 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit. | Posted | Count of Participants | Participants | 6 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Swab samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had swab samples collected at Week 7 instead of the intended 8-week timepoint. | Posted | Count of Participants | Participants | 8 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Soft Stimuli | IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm. | Study was terminated in advance of the 20-week timepoint and swab samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for soft stimuli results to report. | Posted | 20 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, toothpick samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for hard stimuli results data to report. | Posted | 24 hours post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Toothpick samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit. | Posted | Count of Participants | Participants | 1 week post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Toothpick samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of region L1 in which toothpick samples were able to be collected from 8 of 9 patients who attended their Week 2 visit. | Posted | Count of Participants | Participants | 2 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit. | Posted | Count of Participants | Participants | 3 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit. | Posted | Count of Participants | Participants | 4 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Toothpick samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit. | Posted | Count of Participants | Participants | 5 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit. | Posted | Count of Participants | Participants | 6 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Toothpick samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had toothpick samples collected at 7 weeks instead of the intended 8-week collection timepoint. | Posted | Count of Participants | Participants | 8 weeks post-surgery |
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| Primary | Inferior Alveolar Nerve Function for Hard Stimuli | IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm. | Study was terminated in advance of the 20-week timepoint and toothpick samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for hard stimuli results to report. | Posted | 20 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, VAS scores were not obtained from any of the patients at 24 hours post-surgery and there are no post-operative pain results data to report. | Posted | 24 hours post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 1-week post-operative pain (VAS) data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit. | Posted | Mean | Standard Deviation | score on a scale | 1 week post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 2-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 3-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 3 visit. | Posted | Mean | Standard Deviation | score on a scale | 3 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 4-week post-operative pain (VAS) data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 5-week post-operative pain (VAS) data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 6-week post-operative pain (VAS) data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | 8-week post-operative pain (VAS) data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had VAS data collected at 7 weeks instead of the intended 8-week collection timepoint. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks post-surgery |
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| Secondary | Post-operative Pain | Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics. | Study was terminated in advance of the 20-week timepoint and the VAS questionnaire was not administered to, nor were data collected from, any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative pain results to report. | Posted | 20 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, mandibular swelling measurements were not obtained from any of the patients at 24 hours post-surgery and there is no mandibular swelling results data to report. | Posted | 24 hours post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 1-week post-operative mandibular swelling data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit. | Posted | Mean | Standard Deviation | millimeters | 1 week post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 2-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit. | Posted | Mean | Standard Deviation | millimeters | 2 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 3-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from 7 of 8 patients in the Sham intervention arm who attended their 3-week visit. | Posted | Mean | Standard Deviation | millimeters | 3 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 4-week post-operative mandibular swelling data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit. | Posted | Mean | Standard Deviation | millimeters | 4 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 5-week post-operative mandibular swelling data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit. | Posted | Mean | Standard Deviation | millimeters | 5 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 6-week post-operative mandibular swelling data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit. | Posted | Mean | Standard Deviation | millimeters | 6 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | 8-week post-operative mandibular swelling data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had Post-operative mandibular swelling data collected at 7 weeks instead of the intended 8-week collection timepoint. | Posted | Mean | Standard Deviation | millimeters | 8 weeks post-surgery |
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| Secondary | Post-operative Mandibular Swelling | Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics. | Study was terminated in advance of the 20-week timepoint and post-operative mandibular swelling measurements were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative mandibular swelling results to report. | Posted | 20 weeks post-surgery |
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| 0 |
| 12 |
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| 12 |
| 0 |
| 12 |
| EG001 | Sham Intervention | Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine. Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
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