Efficacy of 0.1% chlorine dioxide mouthwash in reducing oral malodour

• Register: ISRCTN
• Last refreshed on: 10 August 2020
• Main ID: ISRCTN75902618
• Date of registration: 15/03/2018
• Prospective Registration: No
• Primary sponsor: University of Medicine and Pharmacy, Ho Chi Minh City
• Public title: Efficacy of 0.1% chlorine dioxide mouthwash in reducing oral malodour
• Scientific title: Efficacy of 0.1% chlorine dioxide mouthwash in reducing oral malodour – a 2-week randomized double-blind cross-over study
• Date of first enrolment: 01/02/2017
• Target sample size: 39
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN75902618
• Study type: Interventional
• Study design: Cross-over randomized double-blind clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Thuy Pham AV

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Oral malodour/halitosis
Oral Health
Halitosis

Intervention(s)

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 t

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of Medicine and Pharmacy, Ho Chi Minh City

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/04/2017