Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients

Sponsors

Lead Sponsor: The University of Hong Kong

Source 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).

Overall Status Completed
Start Date 2010-10-01
Completion Date 2012-01-01
Primary Completion Date 2011-05-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Gingival index 6 months
Plaque index 6 months
gingival bleeding index 6 months
Secondary Outcome
Measure Time Frame
Salivary cytokines 6 months
Adverse Events 6 months
Salivary bacteria counts 6 months
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Listerine mouthrinse

Description: For six months

Arm Group Label: Listerine

Other Name: essential oils mouthrinse

Intervention Type: Drug

Intervention Name: Chinese Medicine mouthrinse

Description: six months

Arm Group Label: Chinese medicine mouthrinse

Other Name: 5% Fructus mume and 2% soudium bicarbonate

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)

Gender:

All

Minimum Age:

13 Years

Maximum Age:

35 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ricky Wong, PhD Principal Investigator Faculty of Dentistry, The University of Hong Kong
Location
Facility: Faculty of Dentistry, HKU
Location Countries

China

Verification Date

2012-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The University of Hong Kong

Investigator Full Name: Wong Wing Kit, Ricky

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Listerine

Type: Active Comparator

Description: essential oil mouthrinse

Label: Negative control

Type: No Intervention

Description: without intervention

Label: Chinese medicine mouthrinse

Type: Experimental

Description: 5% Fructus Mume extract and 2% sodium bicarbonate

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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