The evaluation of the effects of a prebiotic mouth rinse on the oral ecosystem.
- Conditions
- gingivitisgum disease10004018
- Registration Number
- NL-OMON52714
- Lead Sponsor
- ACTA Dental Research B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the change in microbial composition (Bray-Curtis<br /><br>similarity) measured from baseline to other study visits, in comparison to the<br /><br>control group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Additionally, changes in microbial diversity (species richness, Shannon<br /><br>diversity index), red fluorescing plaque (RFP) and gingival bleeding on<br /><br>marginal probing (BOMP) will be assessed.</p><br>