Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds

Phase 4

Completed

• Conditions: Halitosis
• Interventions: Other: small toothbrush for tongue cleaning; Other: chlorine dioxide

• Registration Number: NCT02689297
• Lead Sponsor: Tokyo Medical and Dental University

Brief Summary

The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds.

Detailed Description

Thirty male monk volunteers who matched with the including criteria were divided randomly into two groups. Both groups were practiced to brush their teeth with scrubbing method for one week. Then, each group were instructed to do different additional protocol regimen- group A have to do mouth washing and tooth brushing and group B have to practice tongue cleaning addition to tooth brushing for three weeks. At the fifth week, both groups were instructed to practice tooth brushing, mouth washing and tongue cleaning. Three different volatile sulfur compounds were measured by oral chroma. Tongue characteristics, oral examination were checked as the outcomes of this study.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-18
• Last Update Submitted: 2016-02-18
• Study First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Clinical diagnosis of oral malodor
• No systemic diseases and no severe dental diseases
• At least 20 functional teeth

Exclusion Criteria

• Risky oral habit (smoking and betel quid chewing)
• Current use of antibiotics or any drugs
• Current use of any kind of mouthwash

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	small toothbrush for tongue cleaning	Small toothbrush for tongue cleaning two times per day for three weeks
group A	chlorine dioxide	Mouthwash (chlorine dioxide 12ml two times per day, for three weeks)

Primary Outcome Measures

Name	Time	Method
Three different volatile sulfur compounds	up to 5weeks	Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma.

Secondary Outcome Measures

Name	Time	Method
Number of teeth with bleeding on probing	up to 5weeks
Tongue coating characteristics	up to 5weeks	As tongue coating characteristics, investigator examined tongue coating score (by using winkle tongue coating index) at the baseline, one week later, four weeks later and five weeks later.
Oral Health examination	up to 5weeks	As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth)
Plaque index score	up to 5weeks