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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06127069
• Other study ID #: 14/07/2021, 129
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: November 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• chitosan brush
debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes
• ultrasonic scaler
debridement of periodontal pockets only with ultrasonic scaler

Locations

Country	Name	City	State
Greece	Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Pocket Depth	the distance from the mucosa margin to the bottom of the periodontal pocket	baseline, 6 weeks, 3 months, 6 months
Primary	MMP-8	levels of matrix metalloproteinase -8 in gingival crevicular fluid	baseline, 6 weeks, 3 months, 6 months
Secondary	Bleeding on Probing	presence or absence of bleeding after probe insertion in the periodontal pocket	baseline, 6 weeks, 3 months, 6 months
Secondary	Clinical Attachment Level	the distance from cementoenamel junction to the bottom of periodontal pocket	baseline, 6 weeks, 3 months, 6 months
Secondary	Gingival Recession	the distance from cementoenamel junction to the mucosa margin	baseline, 6 weeks, 3 months, 6 months