Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wong Wing Kit, Ricky, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01637948
First received: January 3, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Gingivitis
Drug: Listerine mouthrinse
Drug: Chinese Medicine mouthrinse
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Gingival index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Modified gingival index

  • Plaque index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    plaque index

  • gingival bleeding index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    gingival bleeding index


Secondary Outcome Measures:
  • Salivary cytokines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.

  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    the number of participants with side effects or adverse events were recorded throughout the whole study time.

  • Salivary bacteria counts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.


Enrollment: 90
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   13 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637948

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

No publications provided

Responsible Party: Wong Wing Kit, Ricky, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01637948     History of Changes
Other Study ID Numbers: HKCTR-1145
Study First Received: January 3, 2012
Last Updated: July 10, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Chinese medicine
gingivitis
cytokine
microbial

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Listerine
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014