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NCT Number: NCT01637948

Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Dentistry, HKU

Hong Kong, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Listerine mouthrinse

Drug

For six months

Other names: essential oils mouthrinse

Chinese Medicine mouthrinse

Drug

six months

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 11, 2012
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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