Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

July 21, 2011 updated by: Mahidol University

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 20 teeth
  • clinical diagnosis as plaque induced gingivitis
  • having over 80 ppb of volatile sulfur compounds in mouth air

Exclusion Criteria:

  • smoker
  • denture wearer
  • having systemic diseases or oral pathology
  • taking antibiotics 1 month prior to study

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mouthwash A
Mouthwash A: Camellia sinensis mouthwash
Drug: Camellia sinensis mouthwash
mouthrinsing, 2 times/day, for 28 days
Other Names:
  • Green tea mouthwash
Placebo Comparator: Mouthwash B
Mouthwash B: Placebo mouthwash
Drug: Placebo mouthwash
mouthrinsing, 2 times/day, for 28 days
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of volatile sulfur compounds in mouth air (part per billion)
Time Frame: baseline, 30 minutes, 3 hours, 28 days
baseline, 30 minutes, 3 hours, 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Papillary bleeding index
Time Frame: baseline, 28 days
baseline, 28 days

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Supanee Rassameemasmaung, Ph.D, Department of Oral Medicine, Faculty of Dentistry, Mahidol University

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

January 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. No. MU-IRB 2008/177.1211

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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