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The effect of glymur rinse on oral microbiological changes and changes in microbial activity related to halitosis

The effect of glymur rinse on oral microbiological changes and changes in microbial activity related to halitosis - The effect of Glymur rinse on oral microbiological changes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41897
Enrollment
20
Registered
2015-04-22
Start date
2015-05-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

halitose (slechte adem) halitosis oral malodor

Interventions

One group of 10 volunteers will rinse with Glymur (2x10 mL for 30 seconds) 3 times a day for a duration of 14 days and the other group of 10 volunteers will rinse with placebo (2x10 mL for 30 second
halitosis
microbiological changes

Sponsors

ACTA Dental Research BV (ADR)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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:

Design outcomes

Primary

MeasureTime frame
Change in microbiota from baseline to day 14 and/or to day 31 as determined with 16S Next Generation Sequencing (NGS) microbiology.

Secondary

MeasureTime frame
Reduction in total protease activity as determined by FRET from: - saliva Oral malodor by: - organoleptic score Change in Volatile Sulphur Compounds (VSCs ) determined by OralChroma® - breath sample Extent of tongue coating and tongue body appearance: - Discoloration - Thickness - Tongue body structure and shape Plaque score determined by the modified Silness & Löe plaque score Gingival bleeding determined by the bleeding on marginal probing score Tolerance in test group vs placebo group: - Mouth feel using a VAS score

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)