Determine if the use of Glymur oral rinse for 14 days has an effect on the composition of the oral microbiota. In addition, the effect on total microbial proteolytic activity and oral malodor will be determined.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
halitose (slechte adem)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in microbiota from baseline to day 14 and/or to day 31 as determined
with 16S Next Generation Sequencing (NGS) microbiology.
Secondary outcome
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
Background summary
An unbalanced oral microbial ecology can lead to several types of pathology and
discomfort. These are usually tackled by the use of an anti-microbial
mouthwash. These unspecific mouthwashes actually only reduce the total
microbial load and do not re-establish microbial balance. In the current pilot
trial an alternative approach will we evaluated where instead of killing all
microbes, specifically beneficial microbes will be stimulated. The imbalanced
oral ecology that will be tackled is the one that leads to the discomfort of
oral malodour (or the condition termed halitosis). Here strictly anaerobic
microorganisms that via proteolytic activity produce (smelly) volatile sulphur
compounds dominate oral microbial ecology. The hypothesis is that by using a
mouth rinse that contains nitrate (BM500), conditions are changed in such a way
that they favour nitrate-reducing microorganisms (firmly established as
beneficial oral bacteria) and hence re-establishment of an ecological balance.
As a result (i) proteolytic microorganisms will be outcompeted and (ii)
production of smelly products will be reduced.
Study objective
Determine if the use of Glymur oral rinse for 14 days has an effect on the
composition of the oral microbiota. In addition, the effect on total microbial
proteolytic activity and oral malodor will be determined.
Study design
Single centre, placebo controlled, double-blind exploratory pilot study in 2
groups of 10 systemically healthy volunteers.
Intervention
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 seconds) 3 times a day for a duration of 14
days.
Study burden and risks
The risks for this study are negligible as the Glymur rinse contains components
that are known to be non-hazardous/safe. In addition, the product will only be
used to rinse very shortly and therefore it is anticipated that there will not
be an actual uptake of any components.
The burden for the volunteers that participate in the study is minimal. They
will make 6 short visits to the site and the data for this study will be
obtained by non-invasive samples of the mouth (saliva, tongue and interproximal
plaque). The benefit for the volunteers will be the possible relieve of
halitosis discomfort.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
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
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49303.029.15 |