Clinical trial NCT01637948: Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse
Official title: Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gingivitis
Keywords: Chinese medicine
gingivitis
cytokine
microbial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: Gingival index
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: gingival bleeding index
timeFrame: 6 months
Secondary outcomes:
measure: Salivary cytokines
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
measure: Salivary bacteria counts
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Faculty of Dentistry, HKU
Study officials:
affiliation: Faculty of Dentistry, The University of Hong Kong
name: Ricky Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: