Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Listerine mouthrinse; Drug: Chinese Medicine mouthrinse

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).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Faculty of Dentistry, HKU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Listerine; essential oil mouthrinse	Drug: Listerine mouthrinse; For six months; Other Names: 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 Names: 5% Fructus mume and 2% soudium bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	Modified gingival index	6 months
Plaque index	plaque index	6 months
gingival bleeding index	gingival bleeding index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cytokines	Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.	6 months
Adverse Events	the number of participants with side effects or adverse events were recorded throughout the whole study time.	6 months
Salivary bacteria counts	Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.	6 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Ricky Wong, PhD, Faculty of Dentistry, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: cytokine; gingivitis; Chinese medicine; microbial
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Listerine
• Other Study ID Numbers: HKCTR-1145