Overview

This trial is active, not recruiting.

Condition periodontitis
Treatment camella sinensis gel
Phase phase 2
Sponsor Mahidol University
Start date February 2008
End date December 2010
Trial size 48 participants
Trial identifier NCT00918060, COA. No. MU-IRB 2008/153.0511

Summary

The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo
(Placebo Comparator)
camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo

Primary Outcomes

Measure
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
time frame: baseline, 1, 3 and 6 month after gel had loaded

Secondary Outcomes

Measure
plaque index
time frame: baseline, 1, 3, and 6 month after gel had loaded

Eligibility Criteria

Male or female participants from 34 years up to 74 years old.

Inclusion Criteria: - subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement - no systemic complicated factors - no allergy to green tea or product of green tea - signing in informed consent form Exclusion Criteria: - smoking - pregnancy or lactation - antibiotic premedication or antibiotic intake in previous 3 month

Additional Information

Official title Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Mahidol University.