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

NCT06127069 | Completed DMC

• 1 other identifier: 14/07/2021, 129
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

residual pockets; chitosan; treatment of periodontitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bleeding on Probing

  baseline, 6 weeks, 3 months, 6 months

• Clinical Attachment Level

  baseline, 6 weeks, 3 months, 6 months

• Gingival Recession

  baseline, 6 weeks, 3 months, 6 months

Study Arms (2)

chitosan group

EXPERIMENTAL

debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush

Device: chitosan brush; Device: ultrasonic scaler

control group

ACTIVE COMPARATOR

debridement of residual periodontal pockets with ultrasonic scaler only

Device: ultrasonic scaler

Interventions

chitosan brush DEVICE

debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes

Also known as: Labrida BioClean

chitosan group

ultrasonic scaler DEVICE

debridement of periodontal pockets only with ultrasonic scaler

chitosan group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, Greece

Location

Related Publications (1)

• Tseleki G, Batas L, Davidopoulou S, Wohlfahrt JC, Menexes G, Tsalikis L. Management of residual periodontal pockets using an oscillating chitosan device: A randomized clinical trial. J Periodontol. 2025 Nov 7. doi: 10.1002/jper.70010. Online ahead of print.

  PMID: 41201882 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Lazaros Tsalikis

  Department of Periodontology, School of Dentistry, Aristotle University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, principal investigator

Model Details: randomized parallel arm clinical trial

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: September 8, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)