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

NCT ID: NCT06127069

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2022-11-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

chitosan group

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

Group Type: EXPERIMENTAL

chitosan brush

Intervention Type: DEVICE

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

ultrasonic scaler

Intervention Type: DEVICE

debridement of periodontal pockets only with ultrasonic scaler

control group

debridement of residual periodontal pockets with ultrasonic scaler only

Group Type: ACTIVE_COMPARATOR

ultrasonic scaler

Intervention Type: DEVICE

debridement of periodontal pockets only with ultrasonic scaler

Interventions

chitosan brush

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

Intervention Type: DEVICE

ultrasonic scaler

debridement of periodontal pockets only with ultrasonic scaler

Intervention Type: DEVICE

Other Intervention Names

Labrida BioClean

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Georgia Tseleki

Postgraduate Student, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lazaros Tsalikis

Role: STUDY_CHAIR

Department of Periodontology, School of Dentistry, Aristotle University

Locations

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

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

14/07/2021, 129

Identifier Type: -

Identifier Source: org_study_id