Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Gingival index
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 13 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who have at less 20 permanent teeth
- •Subjects who have a healthy systemic condition
- •Subjects with age range 13-
- •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
Arms & Interventions
Listerine
essential oil mouthrinse
Intervention: Listerine mouthrinse (Drug)
Chinese medicine mouthrinse
5% Fructus Mume extract and 2% sodium bicarbonate
Intervention: Chinese Medicine mouthrinse (Drug)
Outcomes
Primary Outcomes
Gingival index
Time Frame: 6 months
Modified gingival index
Plaque index
Time Frame: 6 months
plaque index
gingival bleeding index
Time Frame: 6 months
gingival bleeding index
Secondary Outcomes
- Salivary cytokines(6 months)
- Adverse Events(6 months)
- Salivary bacteria counts(6 months)
Investigators
Wong Wing Kit, Ricky
Associate Professor
The University of Hong Kong