Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

NCT ID: NCT00932347

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gingivitis Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mouthwash A

Mouthwash A: Camellia sinensis mouthwash

Group Type EXPERIMENTAL

Camellia sinensis mouthwash

Intervention Type DRUG

mouthrinsing, 2 times/day, for 28 days

Mouthwash B

Mouthwash B: Placebo mouthwash

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type DRUG

mouthrinsing, 2 times/day, for 28 days

Interventions

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Camellia sinensis mouthwash

mouthrinsing, 2 times/day, for 28 days

Intervention Type DRUG

Placebo mouthwash

mouthrinsing, 2 times/day, for 28 days

Intervention Type DRUG

Other Intervention Names

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Green tea mouthwash placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Department of Oral Medicine, Faculty of Dentistry, Mahidol University

Principal Investigators

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Supanee Rassameemasmaung, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Oral Medicine, Faculty of Dentistry, Mahidol University

Locations

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Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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COA. No. MU-IRB 2008/177.1211

Identifier Type: -

Identifier Source: org_study_id

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