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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT06127069
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
14.7
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: chitosan brush
  • Device: ultrasonic scaler
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized parallel arm clinical trialrandomized parallel arm clinical trial
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial
Actual Study Start Date :
Sep 8, 2021
Actual Primary Completion Date :
Nov 29, 2022
Actual Study Completion Date :
Nov 29, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Probing Pocket Depth [baseline, 6 weeks, 3 months, 6 months]

      the distance from the mucosa margin to the bottom of the periodontal pocket

    2. MMP-8 [baseline, 6 weeks, 3 months, 6 months]

      levels of matrix metalloproteinase -8 in gingival crevicular fluid

    Secondary Outcome Measures

    1. Bleeding on Probing [baseline, 6 weeks, 3 months, 6 months]

      presence or absence of bleeding after probe insertion in the periodontal pocket

    2. Clinical Attachment Level [baseline, 6 weeks, 3 months, 6 months]

      the distance from cementoenamel junction to the bottom of periodontal pocket

    3. Gingival Recession [baseline, 6 weeks, 3 months, 6 months]

      the distance from cementoenamel junction to the mucosa margin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki Thessaloniki Greece

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    • Study Chair: Lazaros Tsalikis, Department of Periodontology, School of Dentistry, Aristotle University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Georgia Tseleki, Postgraduate Student, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT06127069
    Other Study ID Numbers:
    • 14/07/2021, 129
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Georgia Tseleki, Postgraduate Student, Aristotle University Of Thessaloniki
    residual pockets, chitosan, periodontitis treatment
    Additional relevant MeSH terms:
    Periodontitis
    Chitosan

    Study Results

    No Results Posted as of Nov 13, 2023