Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study

Conditions
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Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe

Intervention / Treatment
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* Device: Laser Therapy
* Procedure: Non-surgical Scaling and Root Planing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years old or older (male or female) Healthy without systemic diseases that may adversely effect healing Not pregnant and no current plans to become pregnant No periodontal treatment in the previous 12 months No systemic antibiotic therapy in the previous 6 months At least two quadrants with periodontitis (ideally opposite side same jaw) Each quadrant must have two or more sites with probing pocket depths ≥ 5mm Each quadrant should include interproximal intrabony defect(s) Exclusion criteria: Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing: Poorly controlled diabetes (HbA1c > 7%) History of bisphosphonate medications History of radiation therapy affecting the proposed treatment site(s) History of immunosuppressive medications (e.g. corticosteroids) History of tobacco use (current or past tobacco use within the past 1 year) Immune compromise caused by disease, treatment or other condition Recent history of periodontal surgery (within the previous 2 years) Recent history of scaling and root planing (within the previous 12 months) Any condition that contraindicates periodontal therapy including surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Controlled, Split-mouth
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRP + Adjunctive Laser Therapy<br>Laser therapy used as an adjunct to scaling and root planing | Device: Laser Therapy<br>* Adjunctive application of laser therapy in the periodontal pocket<br>Procedure: Non-surgical Scaling and Root Planing<br>* Scaling to remove calculus deposits and root planing to smooth root surfaces<br>|
| Active Comparator: SRP alone<br>Scaling and root planing used as conventional non-surgical periodontal therapy | Procedure: Non-surgical Scaling and Root Planing<br>* Scaling to remove calculus deposits and root planing to smooth root surfaces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing