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Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01637948
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
Wong Wing Kit, Ricky, 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.

Condition or disease Intervention/treatment Phase
Gingivitis Drug: Listerine mouthrinse Drug: Chinese Medicine mouthrinse Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
Study Start Date : October 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Listerine
essential oil mouthrinse
Drug: Listerine mouthrinse
For six months
Other Name: essential oils mouthrinse

No Intervention: Negative control
without intervention
Experimental: Chinese medicine mouthrinse
5% Fructus Mume extract and 2% sodium bicarbonate
Drug: Chinese Medicine mouthrinse
six months
Other Name: 5% Fructus mume and 2% soudium bicarbonate

Primary Outcome Measures :
  1. Gingival index [ Time Frame: 6 months ]
    Modified gingival index

  2. Plaque index [ Time Frame: 6 months ]
    plaque index

  3. gingival bleeding index [ Time Frame: 6 months ]
    gingival bleeding index

Secondary Outcome Measures :
  1. Salivary cytokines [ Time Frame: 6 months ]
    Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.

  2. Adverse Events [ Time Frame: 6 months ]
    the number of participants with side effects or adverse events were recorded throughout the whole study time.

  3. Salivary bacteria counts [ Time Frame: 6 months ]
    Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   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 13-35.
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01637948

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Faculty of Dentistry, HKU
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Ricky Wong, PhD Faculty of Dentistry, The University of Hong Kong

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Responsible Party: Wong Wing Kit, Ricky, Associate Professor, The University of Hong Kong Identifier: NCT01637948     History of Changes
Other Study ID Numbers: HKCTR-1145
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Wong Wing Kit, Ricky, The University of Hong Kong:
Chinese medicine
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs