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Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

NCT ID: NCT01637948

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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).

Conditions

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Gingivitis

Keywords

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Chinese medicine gingivitis cytokine microbial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Listerine

essential oil mouthrinse

Group Type ACTIVE_COMPARATOR

Listerine mouthrinse

Intervention Type DRUG

For six months

Negative control

without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Chinese medicine mouthrinse

5% Fructus Mume extract and 2% sodium bicarbonate

Group Type EXPERIMENTAL

Chinese Medicine mouthrinse

Intervention Type DRUG

six months

Interventions

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Listerine mouthrinse

For six months

Intervention Type DRUG

Chinese Medicine mouthrinse

six months

Intervention Type DRUG

Other Intervention Names

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essential oils mouthrinse 5% Fructus mume and 2% soudium bicarbonate

Eligibility Criteria

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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)
Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Wong Wing Kit, Ricky

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricky Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, The University of Hong Kong

Locations

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Faculty of Dentistry, HKU

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HKCTR-1145

Identifier Type: -

Identifier Source: org_study_id