The effect of mouthwashes on intra-oral halitosis (bad breath)

Not Applicable

Completed

• Conditions: Intra-oral halitosis; Oral Health

• Registration Number: ISRCTN18353746
• Lead Sponsor: Academic Centre for Dentistry Amsterdam (ACTA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2024-03-21
• Study Start: 2024-09-19
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1.Adults =18 years of age 2.Classified as systemically healthy as assessed by a medical questionnaire; no systemic diseases3.Periodontally healthy classified according to the periodical periodontal screening (pps) tool: pps 1 or pps 2 with not more than 2 sites with probing pocket depths of 5mm4.Have a minimum of 20 natural teeth5.Having finished the necessary dental treatment(s)6.Willing to brush twice daily and interdental cleaning as usual7.Willing to temporary stop cleaning the tongue and use of an oral irrigator (starts from the screening until the end of the clinical trial)8.Willing not to use any other mouthwash than the provided mouthwash of this clinical trial (starts at least two weeks before the first visit or from screening until the end of the clinical trial)9.Willing to temporary stop using chewing gum (starts at least two weeks before the first visit or from screening until the end of the clinical trial)10.Willing to keep calendar on use of mouthwash11.Willing to give their mobile phone number in order to send the participant a text message to remind them of their appointments and instructions12.Has visit their dentist on regular basis in the past 6 months – 12 months13.Minimal scores for intra-oral halitosis assessment at screening; 13.1.Hydrogen sulfide >112 ppb as measured by OralChroma (Erovic Ademovski et al. 2017)13.2.Total volatile sulfur compound level >160 ppb as determined with a halimeter (Erovic Ademovski et al. 2017) and13.3.Oral organoleptic score =2 (Rosenberg & Mcculloch 1992)14.Self-reported halitosis

Exclusion Criteria

1.Allergy or hypersensitive to any of the ingredients of the products; zinc acetate, chlorhexidine diacetate, cetylpyridinium chloride, essential-oils, fluoride 2.Pps 2 with > 2 sites with a probing pocket dept of 5mm3.Pps 34.Open carious lesions5.Dental students or dental care professionals 6.Self-reported pregnancy and/or lactating7.Systemic medication related to oral dryness8.Systemic antibiotic therapy within the preceding 3 months9.Smoking or quitted smoking <1 year before the screening appointment 10.Extra-oral halitosis (Tangerman & Winkel 2008)11.Night guard 12.Orthodontic brackets (retainer is allowed)13.Removable prosthesis14.Oral piercings

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volatile sulphur compound hydrogen sulfide level (in ppb) assessed with the OralChroma at baseline, day 7 and 21

Secondary Outcome Measures

Name	Time	Method
Measured at baseline, day 7 and 21 unless noted otherwise:1. Methyl mercaptan levels will be assessed by OralChroma2. Total oral sulfide concentration will be measured with the Halimeter device and breath odor intensity with organoleptic scores3. Winkel tongue coating index and the Gomez tongue index will be used to assess the tongue coating assessed 4. Odostomia” questionnaire scores (subject’s perception of his/her own breath odor) will be filled out at at baseline and day 21. As well as subjects’ attitudes towards the mouthwashes used at day 21