Oral Hygiene Procedures on Reduction of Oral Malodor

Halitosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113137
• Other study ID #: OHP-018-EI
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: April 11, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• 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 procedures on reduction of oral malodor.

Description:

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.

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

• 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

Study Design

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

Related Conditions & MeSH terms

• Halitosis

Intervention

Drug:
• group 1: drug: chlorine dioxide
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.

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

Locations

Country	Name	City	State
Japan	Department of oral health promotion	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ei Ei Aung

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volatile sulfur compounds (VSCs)	Total volatile sulfur compounds was measured by Breathron®	5 weeks	Yes
Secondary	Bleeding on probing	gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.	5 weeks	Yes
Secondary	Tongue coating	tongue coating was evaluated by Winkel tongue coating index.	5weeks	Yes
Secondary	Debris index	debris index was evaluated by oral hygiene index.	5 weeks	Yes