Intra-oral halitosis Oral Health
Conditions
Interventions
This study involves a mouthwash product containing zinc acetate and chlorhexidine diacetate without alcohol compared to a negative comparison (water). There will be a positive comparison mouthwash con
Sponsors
Academic Centre for Dentistry Amsterdam (ACTA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults =18 years of age 2. Classified as systemically healthy as assessed by a medical questionnaire; no systemic diseases 3. 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 5mm 4. Have a minimum of 20 natural teeth 5. Having finished the necessary dental treatment(s) 6. Willing to brush twice daily and interdental cleaning as usual 7. 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 mouthwash 11. Willing to give their mobile phone number in order to send the participant a text message to remind them of their appointments and instructions 12. Has visit their dentist on regular basis in the past 6 months – 12 months 13. 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) and 13.3. Oral organoleptic score =2 (Rosenberg & Mcculloch 1992) 14. Self-reported halitosis
Exclusion criteria
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 5mm 3. Pps 3 4. Open carious lesions 5. Dental students or dental care professionals 6. Self-reported pregnancy and/or lactating 7. Systemic medication related to oral dryness 8. Systemic antibiotic therapy within the preceding 3 months 9. 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 prosthesis 14. Oral piercings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volatile sulphur compound hydrogen sulfide level (in ppb) assessed with the OralChroma at baseline, day 7 and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, day 7 and 21 unless noted otherwise: 1. Methyl mercaptan levels will be assessed by OralChroma 2. Total oral sulfide concentration will be measured with the Halimeter device and breath odor intensity with organoleptic scores 3. 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 | — |
Countries
Netherlands
Contacts
Public ContactEveline van der Sluijs
Outcome results
None listed