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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: chitosan brush; Device: ultrasonic scaler

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Chair: Lazaros Tsalikis, Department of Periodontology, School of Dentistry, Aristotle University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: chitosan; residual pockets; treatment of periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: 14/07/2021, 129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No