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NCT Number: NCT00932347

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

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

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Key information

Conditions

Gingivitis Gingival Diseases Halitosis Infections Mouth Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camellia sinensis mouthwash

Drug

mouthrinsing, 2 times/day, for 28 days

Other names: Green tea mouthwash

Placebo Mouthwash

Drug

mouthrinsing, 2 times/day, for 28 days

Other names: placebo

Primary outcomes

  1. level of volatile sulfur compounds in mouth air (part per billion)

    Time frame: baseline, 30 minutes, 3 hours, 28 days

Secondary outcomes

  1. Papillary bleeding index

    Time frame: baseline, 28 days

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 3, 2009
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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