Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device

Study Overview
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Brief Summary
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The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.

Official Title
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Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Device: chitosan brush
* Device: ultrasonic scaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 or over Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing Full mouth plaques scores ≤20% Exclusion Criteria: Subjects that had received antibiotic therapy 6 months prior to initial examination Subjects with compromised systemic conditions Patients undergoing chemotherapy or radiotherapy Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: randomized parallel arm clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chitosan group<br>debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush | Device: chitosan brush<br>* debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes<br>* Other names: Labrida BioClean;Device: ultrasonic scaler<br>* debridement of periodontal pockets only with ultrasonic scaler<br>|
| Active Comparator: control group<br>debridement of residual periodontal pockets with ultrasonic scaler only | Device: ultrasonic scaler<br>* debridement of periodontal pockets only with ultrasonic scaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Pocket Depth | the distance from the mucosa margin to the bottom of the periodontal pocket | baseline, 6 weeks, 3 months, 6 months | 
| MMP-8 | levels of matrix metalloproteinase -8 in gingival crevicular fluid | baseline, 6 weeks, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing | presence or absence of bleeding after probe insertion in the periodontal pocket | baseline, 6 weeks, 3 months, 6 months | 
| Clinical Attachment Level | the distance from cementoenamel junction to the bottom of periodontal pocket | baseline, 6 weeks, 3 months, 6 months | 
| Gingival Recession | the distance from cementoenamel junction to the mucosa margin | baseline, 6 weeks, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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residual pockets, chitosan, treatment of periodontitis