Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment

Periodontitis Clinical Trial

Official title:

Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00918060
• Other study ID #: COA. No. MU-IRB 2008/153.0511
• Status: Unknown status
• Phase: Phase 2
• First received: June 10, 2009
• Last updated: October 9, 2010
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pocket depth reduction, clinical attachment level gain, gingival index, bleeding score		baseline, 1, 3 and 6 month after gel had loaded
Secondary	plaque index		baseline, 1, 3, and 6 month after gel had loaded