Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

The University of Hong Kong90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingivitis

Interventions

Listerine mouthrinseDRUG

For six months

Chinese Medicine mouthrinseDRUG

six months

Eligibility

Sex: ALLMin age: 13 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Faculty of Dentistry, HKU

Hong Kong, China

Outcomes

Primary Outcomes

Gingival index

Modified gingival index

Time frame: 6 months

Plaque index

plaque index

Time frame: 6 months

gingival bleeding index

Time frame: 6 months

Secondary Outcomes

Salivary cytokines

Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.

Time frame: 6 months

Adverse Events

the number of participants with side effects or adverse events were recorded throughout the whole study time.

Time frame: 6 months

Salivary bacteria counts

Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.

Time frame: 6 months

Data from ClinicalTrials.gov

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