Back to results

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Primary Purpose

Gingivitis, Halitosis

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Camellia sinensis mouthwash

Placebo mouthwash

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Camellia sinensis, volatile sulfur compounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mouthwash A

Mouthwash B

Arm Description

Mouthwash A: Camellia sinensis mouthwash

Mouthwash B: Placebo mouthwash

Outcomes

Primary Outcome Measures

level of volatile sulfur compounds in mouth air (part per billion)

Secondary Outcome Measures

Papillary bleeding index

Full Information

NCT ID

NCT00932347

First Posted

July 1, 2009

Last Updated

July 21, 2011

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00932347

Brief Title

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Official Title

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Halitosis

Keywords

Camellia sinensis, volatile sulfur compounds

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mouthwash A

Arm Type

Experimental

Arm Description

Mouthwash A: Camellia sinensis mouthwash

Arm Title

Mouthwash B

Arm Type

Placebo Comparator

Arm Description

Mouthwash B: Placebo mouthwash

Intervention Type

Drug

Intervention Name(s)

Camellia sinensis mouthwash

Other Intervention Name(s)

Green tea mouthwash

Intervention Description

mouthrinsing, 2 times/day, for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo mouthwash

Other Intervention Name(s)

placebo

Intervention Description

mouthrinsing, 2 times/day, for 28 days

Primary Outcome Measure Information:

Title

level of volatile sulfur compounds in mouth air (part per billion)

Time Frame

baseline, 30 minutes, 3 hours, 28 days

Secondary Outcome Measure Information:

Title

Papillary bleeding index

Time Frame

baseline, 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Supanee Rassameemasmaung, Ph.D

Organizational Affiliation

Department of Oral Medicine, Faculty of Dentistry, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

We'll reach out to this number within 24 hrs