NCT00655772

Brief Summary

A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

February 1, 2007

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

April 10, 2008

Status Verified

March 1, 2008

Enrollment Period

28 days

First QC Date

March 28, 2008

Last Update Submit

April 4, 2008

Conditions

Halitosis

Keywords

chlorinedioxidemouthwashorganolepticmeasurementsvolatilesulfurcompounds

Outcome Measures

Primary Outcomes (1)

  • Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements.

    4 hours

Secondary Outcomes (1)

  • Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with the concentrations of 3 kinds gases of human oral malodor analyzing with gas chromatography.

    4 hours

Interventions

Chlorine DioxideOTHER

Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.

Also known as: ClO2 Fresh®

Eligibility Criteria

Age19 Years - 38 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of oral malodor
  • Rinsing the mouthwash

You may not qualify if:

  • oral malodor caused by foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Oral health promotion, Tokyo medical and dental university

Yushima Bunkyo-ku, Tokyo, 113-8549, Japan

Location

Related Publications (1)

  • Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Kawaguchi Y. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor. Trials. 2008 Dec 9;9:71. doi: 10.1186/1745-6215-9-71.

    PMID: 19068114DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

chlorine dioxide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kayoko Shinada, DDS, PhD

    Dept. of Oral health promotion, Tokyo medical and dental university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 10, 2008

Study Start

February 1, 2007

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

April 10, 2008

Record last verified: 2008-03

Locations

JP(1)