Controlled Clinical Trial of Traditional Chinese Medicine... | NCT01637948

Studies
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

NCT01637948

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Jul 11, 2012Estimated

Enrollment

90Actual

Phase

Phase 1

Conditions

Gingivitis

Interventions

Listerine mouthrinse
Chinese Medicine mouthrinse

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

May 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 3, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2012

Last Update Posted Date

Jul 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wong Wing Kit, Ricky, Associate Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Listerine mouthrinse	Drug	For six months	Listerine	essential oils mouthrinse

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricky Wong, PhD	Faculty of Dentistry, The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, HKU		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided