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| Name | Class |
|---|---|
| Biolase Inc | INDUSTRY |
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The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP + Adjunctive Laser Therapy | Experimental | Laser therapy used as an adjunct to scaling and root planing |
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| SRP alone | Active Comparator | Scaling and root planing used as conventional non-surgical periodontal therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Therapy | Device | Adjunctive application of laser therapy in the periodontal pocket |
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| Measure | Description | Time Frame |
|---|---|---|
| Probing Pocket Depth | This is a measure from base of pocket to gingival margin. | 12 months |
| Sites That Bleed on Probing | Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement. | 12 months |
| Gingival Recession | Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction. | 12 months |
| Clinical Attachment Level | Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal Microbiome | Assess changes in periodontal microbiome using DNA sequencing | 12 months |
| Patient Reported Outcomes: VAS Questionnaire | Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry R Klokkevold, DDS, MS | UCLA School of Dentistry, Section of Periodontics | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Periodontal Sites Assigned to SRP or SRP + Adjunctive Laser Therapy | Each participant had one or more periodontal sites randomly assigned to scaling and root planing only (Standard of Care) or to Laser therapy in addition to scaling and root planing |
| FG001 | Pilot Procedure Arm |
| 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 | Jun 30, 2016 |
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Randomized, Controlled, Split-mouth
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| Non-surgical Scaling and Root Planing | Procedure | Scaling to remove calculus deposits and root planing to smooth root surfaces |
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| 12 months |
Preliminary enrollment of individuals to pilot-test the protocol |
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| NOT COMPLETED |
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17 participants were enrolled in the main study, with a total of 49 Test and 49 Control sites (periodontal pockets)
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| ID | Title | Description |
|---|---|---|
| BG000 | Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone | Enrolled participants each had multiple periodontal sites randomly assigned to receive scaling and root planing as conventional non-surgical periodontal therapy, or Laser therapy as an adjunct to scaling and root planing. |
| BG001 | Pilot Procedure Arm | Preliminary enrollment of individuals to pilot-test the protocol |
| 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, Categorical | Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control. | Count of Participants | 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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| 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 | Probing Pocket Depth | This is a measure from base of pocket to gingival margin. | 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures < 4mm excluded from analyses. The preliminary pilot participants were not assessed for outcome measures. | Posted | Mean | Standard Deviation | mm | 12 months | Periodontal pockets | Periodontal pockets |
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| Primary | Sites That Bleed on Probing | Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement. | 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures. | Posted | Number | percentage of sites with bleeding | 12 months | Periodontal pockets | Periodontal pockets |
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| Primary | Gingival Recession | Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction. | 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures. | Posted | Mean | Standard Deviation | mm | 12 months | Periodontal pockets | Periodontal pockets |
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| Primary | Clinical Attachment Level | Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession). | 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures. | Posted | Mean | Standard Deviation | mm | 12 months | Periodontal pockets | Periodontal pockets |
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| Secondary | Periodontal Microbiome | Assess changes in periodontal microbiome using DNA sequencing | Microbiome results will not be available for analysis until April 2021 | Posted | 12 months |
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| Secondary | Patient Reported Outcomes: VAS Questionnaire | Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction. | 15 participants had a total of 90 sites (periodontal pockets), randomized 45 to Test and 45 to Control interventions. Pilot enrollees were not assessed for outcome measures. | Posted | Mean | Standard Deviation | units on a scale | 12 months | Periodontal pocket sites | Periodontal pocket sites |
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12 months
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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 | SRP + Adjunctive Laser Therapy | Laser therapy used as an adjunct to scaling and root planing Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area. Laser Therapy: Adjunctive application of laser therapy to de-epithelialize the outer surface of gingival margin and within the periodontal pocket. The inner pocket epithelium is removed from the free gingival margin to the level equal with the pocket depth. Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces. Laser Therapy: Following non-surgical scaling and root planing, laser is used to remove smear layer from root surface, to completely remove pocket lining and to degranulate the pocket. Laser is used to decorticate and stimulate the bone at the base of defect. Finally, the laser is used to remove the residual debris while inducing blood coagulation. The surgical site is compressed with moistened 2 x 2 gauze using finger pressure for several minutes to achieve hemostasis. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | SRP Alone | Scaling and root planing used as conventional non-surgical periodontal therapy Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area. Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces. Pockets were flushed with ultrasonic scaler. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Pilot Procedure Arm | Preliminary enrollment of individuals to pilot-test the protocol | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Perry Klokkevold | UCLA Periodontics and Implant Surgery | 3108251927 | pklokkevold@dentistry.ucla.edu |
| Jan 26, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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| Between 18 and 65 years |
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| >=65 years |
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| Participants |
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| Periodontal pockets |
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| Periodontal pockets |
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| Periodontal pockets |
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| Participants |
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| Periodontal pocket sites |
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