NCT00748943

Brief Summary

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Trial Health

100
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 Mar 2007

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

Enrollment Period

2 months

First QC Date

September 8, 2008

Last Update Submit

September 11, 2008

Conditions

Halitosis

Keywords

chlorinedioxidemouthwashhalitosisbacteriasaliva

Outcome Measures

Primary Outcomes (1)

  • Oral malodor

    7 days

Secondary Outcomes (1)

  • Periodontal bacteria

    7 days

Interventions

Chlorine DioxideOTHER

Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)

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

You may not qualify if:

  • Oral malodor caused by foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.

    PMID: 20152022DERIVED

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

September 8, 2008

First Posted

September 9, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

September 12, 2008

Record last verified: 2008-09