Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 1

Conditions: Gingivitis

Treatments: Drug: Listerine mouthrinse; Drug: Chinese Medicine mouthrinse

Study type: Interventional

Funder types: Other

Identifiers

NCT01637948

HKCTR-1145

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 13 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Listerine

Active Comparator group

Description:

essential oil mouthrinse

Treatment:

Drug: Listerine mouthrinse

Negative control

No Intervention group

Description:

without intervention

Chinese medicine mouthrinse

Experimental group

Description:

5% Fructus Mume extract and 2% sodium bicarbonate

Treatment:

Drug: Chinese Medicine mouthrinse