To study the effect of sweetener oral rinses on the oral microbiome composition.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the microbiome composition of dental plaque and
tongue swabs before and after the 2-weeks challenge.
Secondary outcome
The secondary study parameter is the amount of red fluorescent plaque (RFP)
before and after the 2-weeks challenge.
Background summary
From previous work done at our department, we expect that carbohydrates will
steer the ecosystem away from proteolytic capacity which is associated with gum
disease. Hence, it is interesting to investigate whether such a change in the
oral ecology will occur. Because then a mouth rinse of a carbohydrate sweetener
dissolved in water may aid in the treatment of gum disease or periodontal
disease.
Study objective
To study the effect of sweetener oral rinses on the oral microbiome
composition.
Study design
Five groups of 14 people will use 3 times daily an oral rinse for 2 weeks (5
randomly assigned sweeteners: one sweetener per group). Subjects are seen 7
times in a period of 5 to 7 weeks including the screening visit. After
inclusion, during the 6 visits, biological samples and data are collected:
dental plaque samples, tongue swab sample, salivary pH is measured and
QLF-photos are taken. DMFS is recorded once. The composition of individual oral
bacterial communities will be determined using 16S rRNA amplicon sequencing.
The data will be analysed using in house pipelines for microbial ecology
analyses. We expect that the sweeteners will steer the ecosystem away from
proteolytic capacity and hence will increase its resilience to gum disease.
Intervention
A mouth rinse containing a sweetener in water 3 times daily after the main
meals. The rinse contains a 10% tagatose, trehalose, inulin, palatinose or
glucose solution.
Study burden and risks
During the screening visit, people with high caries risk and over 50% inflamed
gums will be excluded. The burden consists of 3 times a day rinsing of the oral
cavity with 10 mL of fluid (two times 30 seconds rinses) for 2 weeks. The rinse
contains a 10% tagatose, trehalose, inulin, palatinose or glucose solution. The
sweetener solutions have a pleasant taste. The rinses are used after the 3 main
meals. The number of site visits is 7 including the screening. After inclusion
before each site visit, the subjects are asked not to clean their teeth 24 h
prior to the visit. We also request not to eat or drink 2 h prior to the site
visit except for still water. During the visits, plaque samples are collected
from the teeth with a plastic dental instrument, a tongue swab is taken which a
microbrush, salivary pH is measured outside the oral cavity with a pH-meter
after taking two drops of saliva. To minimize the risk of developing oral
disease, subjects will rinse for only 2 weeks.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
1. Healthy, ASA I as assessed by medical questionnaire
2. Non-smokers: definition non-smoker: <1 cigarette every day for at least one year
3. Minimum of 20 natural teeth: at least 5 evaluable teeth in each quadrant
4. 17 * 50% bleeding on probing
Exclusion criteria
1. Smokers
2. Overt dental caries
3.DPSI *3+ - 4 (Dutch Periodontal Screening Index)
4. Removable (partial) dentures
5. Removable night guard
6. Oral and/or peri-oral piercings
7. Apparent oral lesions (aphthous ulcers excluded)
8. Presence of orthodontic banding (except for lingual retention wire)
9. Participation in a clinical study within the previous 30 days
10. Great chewing-gum consumer > 3 gums a day
11. Self-reported pregnancy or breastfeeding
12. Use of antibiotics during the last 2 months
13. Need of antibiotic prophylaxis prior to dental treatment. The use of anti-inflammatory drugs on a regular basis. Evidence of any systemic disease or compromised health condition
14. Adverse medical history or long-term prescribed medication (except for anti-contraceptives).
15. Allergic to soy (beans), milk, eggs, gluten or lupin (beans).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial Register NL7525 |
| CCMO | NL68654.100.19 |
| OMON | NL-OMON23131 |