Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Mahidol University

Status and phase: Completed; Phase 2

Conditions: Halitosis; Gingivitis

Treatments: Drug: Camellia sinensis mouthwash; Drug: Placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT00932347

COA. No. MU-IRB 2008/177.1211

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Mouthwash A

Experimental group

Description:

Mouthwash A: Camellia sinensis mouthwash

Treatment:

Drug: Camellia sinensis mouthwash

Mouthwash B

Placebo Comparator group

Description:

Mouthwash B: Placebo mouthwash

Treatment:

Drug: Placebo mouthwash