SRP in Combination With PERIOWAVE in Comparison to SRP Alone in Chronic Periodontitis

Study Overview
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Brief Summary
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This study is to determine whether scaling and root planning (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.

Detailed Description
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Extensive research has shown that lethal photosensitization with low levels of laser light is an effective method of killing numerous types of organisms. This therapy avoids the use of antibiotics along with their potential side effects. The initial application of this therapy to the oral cavity is particularly appropriate since the therapy can be applied topically either in a specific or general fashion, killing is immediate and resistance is unlikely as it is free radical-mediated. In addition, the disease states being treated (gingivitis & periodontitis) are highly prevalent and associated with significant morbidity. The equipment and costs of this therapy are simple, easily applied and relatively inexpensive compared with current therapies. Based on the scientific data to date this therapy has the potential of significantly improving the oral health of those affected. This is a pivotal, prospective, randomized, examiner blinded, multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease.

Official Title
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Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis, Using Scaling and Root Planing (SRP) in Conjunction With PerioWave, Compared to SRP Alone

Conditions
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Periodontitis

Intervention / Treatment
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* Device: PERIOWAVE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is capable of giving informed consent Subject is willing to sign a consent form Adult male or female ≥ the age of 18 Having been diagnosed with chronic periodontitis >18 fully erupted teeth Has had no periodontal instrumentation in the four months prior to the initiation of study treatment Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study Exclusion Criteria: Is pregnant or nursing or who plans to become pregnant in the next 4 months Having significant liver disease by subject report Having an active malignancy of any type by subject report Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol Having any significant chronic disease (either acute or chronic) with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave® Having an active periapical abscess or periodontal abscess Treatment with antibiotics with in the 1-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc) by report of the subject History of acute necrotizing ulcerative gingivitis Known allergy to Methylene Blue Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report Currently uses anti-coagulant therapy at therapeutic doses Currently uses photosensitizing medications Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study

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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No

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
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PERIOWAVE|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Periodontal Pocket Depth |  | 6, 12, 24, 36, 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Bleeding on Probing |  | 6, 12, 24, 36, 48 weeks | 
| Increase in Clinical Attachment Level |  | 6, 12, 24, 36, 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Photodynamic Disinfection, PERIOWAVE, Scaling and Root Planing, SRP