NCT00932347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

1.7 years

First QC Date

July 1, 2009

Last Update Submit

July 21, 2011

Conditions

GingivitisHalitosis

Keywords

Camellia sinensisvolatile sulfur compounds

Outcome Measures

Primary Outcomes (1)

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

    baseline, 30 minutes, 3 hours, 28 days

Secondary Outcomes (1)

  • Papillary bleeding index

    baseline, 28 days

Study Arms (2)

Mouthwash A

EXPERIMENTAL

Mouthwash A: Camellia sinensis mouthwash

Drug: Camellia sinensis mouthwash

Mouthwash B

PLACEBO COMPARATOR

Mouthwash B: Placebo mouthwash

Drug: Placebo mouthwash

Interventions

Camellia sinensis mouthwashDRUG

mouthrinsing, 2 times/day, for 28 days

Also known as: Green tea mouthwash
Mouthwash A
Placebo mouthwashDRUG

mouthrinsing, 2 times/day, for 28 days

Also known as: placebo
Mouthwash B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

GingivitisHalitosis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Supanee Rassameemasmaung, Ph.D

    Department of Oral Medicine, Faculty of Dentistry, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 3, 2009

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

TH(2)