Condition category
Oral Health
Date applied
25/02/2018
Date assigned
15/03/2018
Last edited
09/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to assess the effects of a mouthwash containing 0.1% ClO2 used for 2 weeks on oral malodour (bad breath), periodontal (gum) status, salivary pH and flow rate, tongue coating, and bacteria in saliva.

Who can participate?
First- to third-year students at the University of Medicine and Pharmacy, Ho Chi Minh City with oral malodour

What does the study involve?
Participants are randomly allocated into two groups. In the first stage, one group is instructed to rinse with the experimental mouthwash, while the other group is instructed to rinse with the control mouthwash for 2 weeks. After 4 weeks of washing out, in the second stage, each group uses the other mouthwash for 2 weeks. Oral malodour, periodontal status, tongue coating, salivary pH and flow rate, and salivary bacteria are evaluated at the start of the study and after 2 weeks of mouthwash use.

What are the possible benefits and risks of participating?
Patients receive all treatments free of charge. No risks are expected.

Where is the study run from?
University of Medicine and Pharmacy, Ho Chi Minh City (Viet Nam)

When is the study starting and how long is it expected to run for?
February 2017 to April 2017

Who is funding the study?
University of Medicine and Pharmacy, Ho Chi Minh City (Viet Nam)

Who is the main contact?
Dr Thuy Pham AV

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thuy Pham AV

ORCID ID

Contact details

Department of Periodontology
Faculty of Odonto-Stomatology
University of Medicine and Pharmacy
652 Nguyen Trai St
Ward 11
District 5
Ho Chi Minh City
700000
Viet Nam

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of 0.1% chlorine dioxide mouthwash in reducing oral malodour – a 2-week randomized double-blind cross-over study

Acronym

Study hypothesis

To assess the inhibitory effects of a mouthwash containing 0.1% ClO2 used for 2 weeks on oral malodour, periodontal status, salivary pH and flow rate, tongue coating, Gram positive and negative bacteria in saliva.

Ethics approval

Ethical Committee of the University of Medicine and Pharmacy, Ho Chi Minh City, 15/01/2017, ref: 16142-ĐHYD, 186/ĐHYD-HĐ

Study design

Cross-over randomized double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Oral malodour/halitosis

Intervention

The experimental sample was commercial mouthwash (TheraBreath® Mild Mint Oral Rinse) containing 0.1% chlorine dioxide. The control sample was 0.9% sodium chloride solution with additional flavours to imitate the taste of the experimental oral rinse. Both mouthrinse samples (experimental and control) were put into identical white opaque plastic bottles. An independent person, outside this study, labelled the bottles with code A or B for experimental or control mouthwash. Neither examiners nor subjects in the research group knew which were the experimental or control samples until the study was completed.

This study was a cross-over, randomized, double-blinded clinical trial with a 4-week wash-out period between two 2-week stages. The subjects were randomized into two groups by a person who was outside the trial. This assignment was secured secretly in the patient records, and only revealed (if necessary) after the trial ended.

In the first stage, one group was instructed to rinse with 30 mL of the experimental mouthwash twice daily (morning and evening) for 2 weeks, while the other was instructed to rinse with 30 mL of the control mouthwash in the same way. Participants were instructed to use their mouthwash in the following way: rinse with 15 mL mouthwash for 30 sec, then spit and continue to gargle with 15 mL mouthwash for 15 sec. After 4 weeks of wash-out, in the second stage, each group used the other mouthwash for 2 weeks. During the study, participants were given dentifrice without antibacterial agents to use, and continued to brush teeth in their own way. They were also not allowed to rinse with other kinds of mouthwash nor brush their tongues.

Subjects were evaluated for organoleptic scores and the amount of VSCs at baseline (T0), after 12 h (T1) and after 2 weeks (T2) of using mouthwash. PI, GI, BOP, tongue coating score, salivary pH and flow rate, and the number of salivary bacteria of species A. actinomycetemcomitans, F. nucleatum, P. gingivalis, S. moorei, S. salivarius, T. denticola and T. forsythia were evaluated at baseline (T0) and after 2 weeks of using mouthwash (T2).

Intervention type

Other

Phase

Drug names

Primary outcome measures

VSC concentration measured with hydrogen sulphide (H2S) and methyl mercaptan (CH3SH) gas analysis machine at baseline, 12 hours and 2 weeks

Secondary outcome measures

1. Organoleptic score measured directly by an examiner using 0-5 scale at baseline, 12 hours and 2 weeks
2. Plaque index (PI) and gingival index (GI) assessed using the method of Loe and Silness (Loe, 1967), and bleeding on probing (BOP) evaluated at four sites (distal, buccal, mesial and lingual) on all teeth except for third molars at baseline, 12 hours and 2 weeks
3. Evaluation of tongue coating based on the criteria of Winkel et al. (2003) at baseline, 12 hours and 2 weeks
The pH of resting saliva determined by a pH paper test (Saliva-Check Buffer Kit, GC, Japan) at baseline, 12 hours and 2 weeks
4. Detection and determination of bacterial species A. actinomycetemcomitans, F. nucleatum, P. gingivalis, S. moorei, S. salivarius, T. denticola and T. forsythia in resting saliva using a multiplex real-time polymerase chain reaction (PCR) assay at baseline and after 2 weeks

Overall trial start date

01/02/2017

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. First- to third-year students at the University of Medicine and Pharmacy, Ho Chi Minh City who had halitosis as a chief complaint
2. An organoleptic score ≥ 2 based on the Rosenberg scale (Rosenberg & McCulloch, 1992)
3. A level of H2S > 1.5 ng/10 mL or CH3SH > 0.5 ng/10 mL (1) determined by OralChromaTM

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

During the study, 5 subjects were eliminated because they did not participate in the full protocol, so that the final sample was 39 participants.

Participant exclusion criteria

1. Gastrointestinal diseases or respiratory diseases
2. Habit of smoking
3. Wearing dentures or orthodontic appliances
4. Undergoing any antibiotic treatment 1 month before and during the study course

Recruitment start date

01/02/2017

Recruitment end date

15/02/2017

Locations

Countries of recruitment

Viet Nam

Trial participating centre

University of Medicine and Pharmacy, Ho Chi Minh City
Faculty of Odonto-Stomatology
Ho Chi Minh
700000
Viet Nam

Sponsor information

Organisation

University of Medicine and Pharmacy, Ho Chi Minh City

Sponsor details

652 Nguyen Trai street
district 5
Ho Chi Minh City
700000
Viet Nam

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Medicine and Pharmacy, Ho Chi Minh City

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol and statistical analysis plan are available for any researchers who wish to access the data to achieve aims in the approved proposal. Please contact pavthuy@ump.edu.vn to request. Planned publication of the study results in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Pham Anh Vu Thuy (pavthuy@ump.edu.vn) for researchers who wish to access the data to achieve aims in the approved proposal. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) are available from 3 months to 5 years following article publication.

Intention to publish date

08/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

After 2 weeks, the experimental mouthwash appeared significantly reducing oral malodour parameters, plaque index, tongue coating score and the amounts of F. nucleatum, S. moorei, T. denticola and T. forsythia, compared to those at baseline. In conclusion, mouthwash containing 0.1% ClO2 is effective in reducing oral malodour, dental plaque, tongue coating, the amounts of salivary Gram positive and negative bacteria.

Publication citations

Additional files

Editorial Notes