Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

NCT01637948 | Completed Phase 1

• 1 other identifier: HKCTR-1145
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

Chinese medicine; gingivitis; cytokine; microbial

Outcome Measures

Primary Outcomes (3)

• Gingival index

  Modified gingival index

  6 months

• Plaque index

  plaque index

  6 months

• gingival bleeding index

  gingival bleeding index

  6 months

Secondary Outcomes (3)

• Salivary cytokines

  6 months

• Adverse Events

  6 months

• Salivary bacteria counts

  6 months

Study Arms (3)

Listerine

ACTIVE COMPARATOR

essential oil mouthrinse

Drug: Listerine mouthrinse

Negative control

NO INTERVENTION

without intervention

Chinese medicine mouthrinse

EXPERIMENTAL

5% Fructus Mume extract and 2% sodium bicarbonate

Drug: Chinese Medicine mouthrinse

Interventions

Listerine mouthrinse DRUG

For six months

Also known as: essential oils mouthrinse

Listerine

Chinese Medicine mouthrinse DRUG

six months

Also known as: 5% Fructus mume and 2% soudium bicarbonate

Chinese medicine mouthrinse

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Faculty of Dentistry, HKU

Hong Kong, China

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ricky Wong, PhD

  Faculty of Dentistry, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: July 11, 2012
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

CN (1)