This study aims to evaluate the changes in microbial composition of the oral microbiome (main objective), changes in proportion of the red fluorescing plaque (RFP) and in gingival bleeding on marginal probing (BOMP) (secondary objectives) after…
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 change in microbial composition (Bray-Curtis
similarity) measured from baseline to other study visits, in comparison to the
control group.
Secondary outcome
Additionally, changes in microbial diversity (species richness, Shannon
diversity index), red fluorescing plaque (RFP) and gingival bleeding on
marginal probing (BOMP) will be assessed.
Background summary
Healthy oral ecosystem is in balance (symbiosis) with the host. It is resilient
towards environmental stress and is able to recover from such a stress without
collapsing or entering the state of dysbiosis. There is however very little
known about the mechanisms involved in maintaining and enhancing this
resilience and oral health. Inulin has demonstrated a potential as an oral
prebiotic, but its effects on strengthening the oral resilience towards
gingivitis (inflammation of gums) are unknown yet.
Study objective
This study aims to evaluate the changes in microbial composition of the oral
microbiome (main objective), changes in proportion of the red fluorescing
plaque (RFP) and in gingival bleeding on marginal probing (BOMP) (secondary
objectives) after exposure to inulin-containing mouth rinse, before, during and
after an experimental gingivitis challenge.
Study design
This study is a single-centre, challenge intervention, single-blind, parallel
two-groups randomized, placebo-controlled clinical trial.
Intervention
Study subjects will rinse 4 times daily with either 10% inulin solution (test)
or 0.5% sodium chloride (salt) solution for 6 weeks. After the first 2 weeks
(wash-in period), subjects will abstain from any oral hygiene procedures
(experimental gingivitis period) for 2 weeks. The last 2 weeks subjects will
continue with normal oral hygiene and a mouth-rinse use (recovery phase).
Study burden and risks
The study will include healthy subjects. During the screening visit, subjects
with high caries experience (DMFS>15) and over 50% inflamed gums will be
excluded. The subjects will visit ACTA 8 times, including a screening visit, in
approximately 8-10 weeks. There will be no invasive procedures performed.
Subjects will have to rinse with either the test (10% inulin; an accepted food
ingredient) or control (0.5% kitchen salt) solution and will have to abstain
from any oral hygiene measures for 14 days. Each visit will last about 30
minutes. There is no direct benefit for the subjects.
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Listed location countries
Age
Inclusion criteria
1. Willing and able to give written informed consent and willing and able to
comply to all study procedures
2. Mentally-competent and >= 16 years and not above 35 years
3. ASA I, healthy as assessed by a medical questionnaire
4. Non-smoking: definition non-smoker: <1 cigarette every day for at least one
year
5. Minimum of 20 natural teeth: at least one un-crowned first or second molar
must be present in each quadrant
6. Having visited the dentist for a regular check-up within the last year and
having finished the necessary treatment(s)
7. Less than 50% gingival bleeding on probing
Exclusion criteria
1. Not meeting the inclusion criteria
2. ACTA dental student or ACTA employee
3. InHolland oral hygiene student or InHolland employee
4. Participation in a clinical study within the previous 30 days
5. Allergy/intolerance to the ingredients of the test product
General health and use of medication:
6. Smoker
7. Abuse of drugs or alcohol
8. Self-reported pregnancy or breastfeeding
9. Use of antibiotics during the last 3 months
10. Use of anti-inflammatory drugs on a regular basis
11. ASA II or more
12. Prescribed medication (except for contraceptives)
Oral health:
13. Overt dental caries
14. DMFS score > 15
15. Anyone with a dental pocket probing depth >=4-5mm with bleeding on probing
plus attachment loss >= 2 mm (Dutch Periodontal Screening Index score 3+/ 4) or
a pocket >= 6 mm
16. Clearly inflamed gingiva at the screening, presented as >50% bleeding on
probing (BOP)
17. Removable (partial) dentures
18. Removable night guard
19. Oral and/or peri-oral piercings
20. Apparent oral lesions (aphthous ulcers excluded)
21. Presence of orthodontic banding (except for lingual retention wire)
22. Ongoing or planned elective dental treatment involving endodontic treatment
and crown and bridge preparation
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 | NL72143.018.19 |