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Completed

NCT Number: NCT06127069

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chitosan brush

Device

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

Other names: Labrida BioClean

Ultrasonic scaler

Device

debridement of periodontal pockets only with ultrasonic scaler

Primary outcomes

  1. Probing Pocket Depth

    Time frame: baseline, 6 weeks, 3 months, 6 months

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

  2. MMP-8

    Time frame: baseline, 6 weeks, 3 months, 6 months

    levels of matrix metalloproteinase -8 in gingival crevicular fluid

Secondary outcomes

  1. Bleeding on Probing

    Time frame: baseline, 6 weeks, 3 months, 6 months

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

  2. Clinical Attachment Level

    Time frame: baseline, 6 weeks, 3 months, 6 months

    the distance from cementoenamel junction to the bottom of periodontal pocket

  3. Gingival Recession

    Time frame: baseline, 6 weeks, 3 months, 6 months

    the distance from cementoenamel junction to the mucosa margin

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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