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Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Listerine mouthrinse
Chinese Medicine mouthrinse
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Chinese medicine, gingivitis, cytokine, microbial

Eligibility Criteria

13 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faculty of Dentistry, HKU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

Listerine

Negative control

Chinese medicine mouthrinse

Arm Description

essential oil mouthrinse

without intervention

5% Fructus Mume extract and 2% sodium bicarbonate

Outcomes

Primary Outcome Measures

Gingival index
Modified gingival index
Plaque index
plaque index
gingival bleeding index
gingival bleeding index

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2012
Last Updated
July 10, 2012
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01637948
Brief Title
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse
Official Title
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Chinese medicine, gingivitis, cytokine, microbial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Listerine
Arm Type
Active Comparator
Arm Description
essential oil mouthrinse
Arm Title
Negative control
Arm Type
No Intervention
Arm Description
without intervention
Arm Title
Chinese medicine mouthrinse
Arm Type
Experimental
Arm Description
5% Fructus Mume extract and 2% sodium bicarbonate
Intervention Type
Drug
Intervention Name(s)
Listerine mouthrinse
Other Intervention Name(s)
essential oils mouthrinse
Intervention Description
For six months
Intervention Type
Drug
Intervention Name(s)
Chinese Medicine mouthrinse
Other Intervention Name(s)
5% Fructus mume and 2% soudium bicarbonate
Intervention Description
six months
Primary Outcome Measure Information:
Title
Gingival index
Description
Modified gingival index
Time Frame
6 months
Title
Plaque index
Description
plaque index
Time Frame
6 months
Title
gingival bleeding index
Description
gingival bleeding index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Salivary cytokines
Description
Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.
Time Frame
6 months
Title
Adverse Events
Description
the number of participants with side effects or adverse events were recorded throughout the whole study time.
Time Frame
6 months
Title
Salivary bacteria counts
Description
Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky Wong, PhD
Organizational Affiliation
Faculty of Dentistry, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, HKU
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

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