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The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM Therapy | Experimental |
| |
| PBM Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM Therapy | Device | After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 . |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | 72 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | 0 hours, 6 hours, 12 hours and 24 hours hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryne Jackson, DMD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PBM Therapy | PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 . |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 14, 2021 |
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| PBM Sham | Device | For the PBM sham similar procedure as PBM therapy will be performed without activating the laser. |
|
| FG001 | PBM Sham | PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PBM Therapy | PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 . |
| BG001 | PBM Sham | PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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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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| 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 | Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | Posted | Mean | Standard Deviation | score on a scale | 72 hours after treatment |
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| Secondary | Pain as Assessed by the Visual Analog Scale | This scale ranges form 0(no pain) to 10(worst pain) | Posted | Mean | Standard Deviation | score on a scale | 0 hours, 6 hours, 12 hours and 24 hours hours after treatment |
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72 hours
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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 | PBM Therapy | PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 . | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | PBM Sham | PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Kirkpatrick, DDS | The University of Texas Health Science Center at Houston | 713-486-4227 | timothy.c.kirkpatrick@uth.tmc.edu |
| Mar 1, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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