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

October 9, 2010 updated by: Mahidol University

Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gel a
Drug: Camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo
Placebo Comparator: gel b
Drug: Camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
plaque index
Time Frame: baseline, 1, 3, and 6 month after gel had loaded
baseline, 1, 3, and 6 month after gel had loaded

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Kanyawat Rattanasuwan, Department of Oral Medicine, Mahidol University
  • Study Chair: Kanyawat Rattanasuwan, Maha Chakri Sirindhorn Dental Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 9, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. No. MU-IRB 2008/153.0511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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