Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Study Overview
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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).

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

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Listerine mouthrinse
* Drug: Chinese Medicine mouthrinse


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Listerine<br>essential oil mouthrinse | Drug: Listerine mouthrinse<br>* For six months<br>* Other names: essential oils mouthrinse;|
| No Intervention: Negative control<br>without intervention | |
| Experimental: Chinese medicine mouthrinse<br>5% Fructus Mume extract and 2% sodium bicarbonate | Drug: Chinese Medicine mouthrinse<br>* six months<br>* Other names: 5% Fructus mume and 2% soudium bicarbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival index | Modified gingival index | 6 months | 
| Plaque index | plaque index | 6 months | 
| gingival bleeding index | gingival bleeding index | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cytokines | Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay. | 6 months | 
| Adverse Events | the number of participants with side effects or adverse events were recorded throughout the whole study time. | 6 months | 
| Salivary bacteria counts | Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese medicine, gingivitis, cytokine, microbial