The effect of glymur rinse on oral microbiological changes and changes in microbial activity related to halitosis
- Conditions
- halitose (slechte adem)halitosisoral malodor
- Registration Number
- NL-OMON41897
- Lead Sponsor
- ACTA Dental Research BV (ADR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Age: >= 18 years - 55 year
- Male and female
- Classified as systemically healthy, assessed by medical questionnaire
- Organoleptic score of >= 2
- Presence of Volatile Sulphur Compounds (VSC*s) using Oral Chroma®
- Minimum of 20 natural teeth: all first molars and second (or third molars) in the upper jaw available
- Agree to present with *overnight* plaque
- Agree to present without eating and drinking 2 hours prior to visit
- Having visited the dentist for a regular check-up within the last year and having finished the necessary treatment.
- Willing and able to give written informed consent
- Willing to consent to use their collected anonymous and coded body materials for further research.
- Anyone presenting with a probing depth >= 5mm with bleeding on probing and attachment loss >= 2 mm, Dutch Periodontal Screening Index score 3+/ 4
- Overt dental caries
- Interproximal restorations between all molars
- Smokers, definition non-smoker: <1 cigarette every day for at least one year
- Removable partial dentures
- Removable night guard
- Oral and/or peri-oral piercings
- Apparent oral lesions (aphthous ulcers excluded)
- Presence of orthodontic banding (except for lingual retention wire)
- Abuse of drugs/ alcohol
- ACTA dental student or ACTA professional
- Participation in a clinical study within the previous 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in microbiota from baseline to day 14 and/or to day 31 as determined<br /><br>with 16S Next Generation Sequencing (NGS) microbiology. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Reduction in total protease activity as determined by FRET from:<br /><br>- saliva<br /><br><br /><br>Oral malodor by:<br /><br>- organoleptic score<br /><br><br /><br>Change in Volatile Sulphur Compounds (VSCs ) determined by OralChroma®<br /><br>- breath sample<br /><br><br /><br>Extent of tongue coating and tongue body appearance:<br /><br>- Discoloration<br /><br>- Thickness<br /><br>- Tongue body structure and shape<br /><br><br /><br>Plaque score determined by the modified Silness & Löe plaque score<br /><br><br /><br>Gingival bleeding determined by the bleeding on marginal probing score<br /><br><br /><br>Tolerance in test group vs placebo group:<br /><br>- Mouth feel using a VAS score</p><br>