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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Device: chitosan brush; Device: ultrasonic scaler

• Registration Number: NCT06127069
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-08
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chitosan group	chitosan brush	debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush
chitosan group	ultrasonic scaler	debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush
control group	ultrasonic scaler	debridement of residual periodontal pockets with ultrasonic scaler only

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece