NCT02689297

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_4

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

September 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

February 8, 2016

Last Update Submit

February 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Oral Health examination

    up to 5weeks

  • Tongue coating characteristics

    up to 5weeks

  • Number of teeth with bleeding on probing

    up to 5weeks

  • Plaque index score

    up to 5weeks

Study Arms (2)

group A

OTHER

Mouthwash (chlorine dioxide 12ml two times per day, for three weeks)

Other: chlorine dioxide

group B

OTHER

Small toothbrush for tongue cleaning two times per day for three weeks

Other: small toothbrush for tongue cleaning

Interventions

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.

group A

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.

group B

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Halitosis

Interventions

chlorine dioxide

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate student, Department of Oral Health Promotion

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 23, 2016

Study Start

September 1, 2013

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

February 23, 2016

Record last verified: 2016-02