Oral Hygiene Procedures on Reduction of Oral Malodor

NCT02113137 | Completed Phase 4 DMC

• 1 other identifier: OHP-018-EI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Halitosis

Keywords

halitosis; chlorine dioxide; tongue cleaning

Outcome Measures

Primary Outcomes (1)

• Volatile sulfur compounds (VSCs)

  Total volatile sulfur compounds was measured by Breathron®

  5 weeks

Secondary Outcomes (3)

• Bleeding on probing

  5 weeks

• Tongue coating

  5weeks

• Debris index

  5 weeks

Study Arms (2)

group 1: drug

EXPERIMENTAL

Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks

Drug: group 1: drug: chlorine dioxide

group 2: device:

EXPERIMENTAL

group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning

Device: group 2: device: small tooth brush for tongue cleaning

Interventions

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.

Also known as: ClO2Fresh®

group 1: drug

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.

group 2: device:

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ei Ei Aung: lead

Study Sites (1)

Department of oral health promotion

Tokyo, Tokyo, 113-8549, Japan

Location

Related Publications (1)

• Aung EE, Ueno M, Zaitsu T, Furukawa S, Kawaguchi Y. Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial. Trials. 2015 Jan 27;16:31. doi: 10.1186/s13063-015-0549-9.

  PMID: 25622725 DERIVED

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• EiEi Aung, student

  Department of oral health promotion

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Graduate student, department of oral health promotion

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 14, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

JP (1)