Effect of Mouthwash Containing Camellia Sinensis Extracts... | NCT00932347

Studies
Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

NCT00932347

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jul 22, 2011Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Gingivitis
Halitosis

Interventions

Camellia sinensis mouthwash
Placebo mouthwash

Countries

Thailand

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 2011

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

Jan 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 1, 2009

First Submission Date that Met QC Criteria

Jul 2, 2009

First Posted Date

Jul 3, 2009Estimated

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 21, 2011

Last Update Posted Date

Jul 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.

Detailed Description

At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mouthwash A	Experimental	Mouthwash A: Camellia sinensis mouthwash	Drug: Camellia sinensis mouthwash
Mouthwash B	Placebo Comparator	Mouthwash B: Placebo mouthwash	Drug: Placebo mouthwash

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Camellia sinensis mouthwash	Drug	mouthrinsing, 2 times/day, for 28 days	Mouthwash A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of volatile sulfur compounds in mouth air (part per billion)		baseline, 30 minutes, 3 hours, 28 days

Secondary Outcomes

Measure	Description	Time Frame
Papillary bleeding index		baseline, 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 20 teeth
clinical diagnosis as plaque induced gingivitis
having over 80 ppb of volatile sulfur compounds in mouth air

Exclusion Criteria:

smoker
denture wearer
having systemic diseases or oral pathology
taking antibiotics 1 month prior to study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Supanee Rassameemasmaung, Ph.D	Department of Oral Medicine, Faculty of Dentistry, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University		Bangkok	Bangkok	10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D006209	Halitosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided