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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02689297
Other study ID # OHP-018-EI-2
Secondary ID
Status Completed
Phase Phase 4
First received February 8, 2016
Last updated February 18, 2016
Start date September 2013
Est. completion date November 2013

Study information

Verified date February 2016
Source Tokyo Medical and Dental University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
chlorine dioxide
First week, subjects were instructed to do regular tooth brushing. After that group A was requested to use chlorine dioxide mouthwash two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
small toothbrush for tongue cleaning
First week, subjects were instructed to do regular tooth brushing. After that group B was requested to brush their tongue with small toothbrush two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tokyo Medical and Dental University

Outcome

Type Measure Description Time frame Safety issue
Primary Three different volatile sulfur compounds Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma. up to 5weeks Yes
Secondary Oral Health examination As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth) up to 5weeks Yes
Secondary Tongue coating characteristics 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. up to 5weeks Yes
Secondary Number of teeth with bleeding on probing up to 5weeks Yes
Secondary Plaque index score up to 5weeks Yes
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