Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637948
• Other study ID #: HKCTR-1145
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2012
• Last updated: July 10, 2012
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Listerine mouthrinse
For six months
• Chinese Medicine mouthrinse
six months

Locations

Country	Name	City	State
China	Faculty of Dentistry, HKU	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival index	Modified gingival index	6 months	No
Primary	Plaque index	plaque index	6 months	No
Primary	gingival bleeding index	gingival bleeding index	6 months	No
Secondary	Salivary cytokines	Salivary inflammatory cytokines (IL-1ß and MIF) levels were detected by ELISA assay.	6 months	No
Secondary	Adverse Events	the number of participants with side effects or adverse events were recorded throughout the whole study time.	6 months	Yes
Secondary	Salivary bacteria counts	Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.	6 months	No