Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Phase 1

Completed

• Conditions: Gingivitis
• Interventions: Drug: Listerine mouthrinse; Drug: Chinese Medicine mouthrinse

• Registration Number: NCT01637948
• Lead Sponsor: The University of Hong Kong

Brief Summary

Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease in China over three thousand years. Certain TCM have scientifically proved to have anti-bacterial property. Patients having orthodontic treatment have higher risks of caries and gum diseases. The purpose of this study was to determine whether the use of TCM Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic patients in maintaining proper oral health.

Detailed Description

The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM) mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria, Streptococci and Lactobacilli counts. Clinical and microbiological examinations were conducted at baseline, 3 and 6 months (T1, T2 and T3).

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-05
• Study Completion: 2012-01
• Study First Submitted: 2012-01-03
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjects who have at less 20 permanent teeth
• Subjects who have a healthy systemic condition
• Subjects with age range 13-35.
• Subjects who are no-smoker;
• Subjects who haven't taken antibiotic medicine within a 2 week period prior
• Subjects who do not currently undergo any medication or will undergo any medication in next six months
• Subjects who have not dental diseases that required ongoing treatment, which would confound the evaluation of result
• Subjects who are competent in giving consents
• Subjects who are not pregnant or lactating women
• Subjects who do not report teeth sensitivity
• Subjects who are not allergic to ethanol
• Subjects presented a minimum level of pre-existing gingivitis (MGI>1) but without peridontitis.(probing depth>4mm)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Listerine	Listerine mouthrinse	essential oil mouthrinse
Chinese medicine mouthrinse	Chinese Medicine mouthrinse	5% Fructus Mume extract and 2% sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
Gingival index	6 months	Modified gingival index
Plaque index	6 months	plaque index
gingival bleeding index	6 months	gingival bleeding index

Secondary Outcome Measures

Name	Time	Method
Salivary cytokines	6 months	Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.
Adverse Events	6 months	the number of participants with side effects or adverse events were recorded throughout the whole study time.
Salivary bacteria counts	6 months	Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.

Trial Locations

Locations (1)

Faculty of Dentistry, HKU; 🇨🇳 Hong Kong, China