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

Mahidol University

Status and phase: Unknown; Phase 2

Conditions: Periodontitis

Treatments: Drug: Camella sinensis gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00918060

COA. No. MU-IRB 2008/153.0511

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 34 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

gel a

Experimental group

Treatment:

Drug: Camella sinensis gel

gel b

Placebo Comparator group

Treatment:

Drug: Camella sinensis gel