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Completed

NCT Number: NCT02113137

Oral Hygiene Procedures on Reduction of Oral Malodor

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of oral health promotion

Tokyo, 113-8549, Japan

About this study

Thirty volunteers who matched with including criteria were divided randomly into two groups. Both groups were instructed to brush their teeth with a scrubbing method for the first one week. Then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (ClO2) mouthwash in another group for three consecutive weeks. After that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. Total volatile sulfur compounds (VSCs) measured by breathtron, tongue coating, plaque score and bleeding on probing (BOP) were outcomes of this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Habit of smoking and betel quid chewing
  • Oral malodor by food and other craniofacial abnormalities
  • Current use of any kind of mouthwash

Treatment and study plan

group 1: drug: chlorine dioxide

Drug

First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures.

group 1 - additional use of 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks besides tooth brushing.

At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing.

Other names: ClO2Fresh®

group 2: device: small tooth brush for tongue cleaning

Device

First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures.

group 2 - additional practice of tongue cleaning by a small tooth brush two times per day, for three consecutive weeks besides tooth brushing.

At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing.

Primary outcomes

  1. Volatile sulfur compounds (VSCs)

    Time frame: 5 weeks

    Total volatile sulfur compounds was measured by Breathron®

Secondary outcomes

  1. Bleeding on probing

    Time frame: 5 weeks

    gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.

  2. Tongue coating

    Time frame: 5weeks

    tongue coating was evaluated by Winkel tongue coating index.

  3. Debris index

    Time frame: 5 weeks

    debris index was evaluated by oral hygiene index.

Sponsors and collaborators

Lead sponsor

Ei Ei Aung

Other

Registry information

Official study title

Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2014
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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