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The evaluation of the effects of a prebiotic mouth rinse on the oral ecosystem.

Completed
Conditions
gingivitis
gum disease
10004018
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
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<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
NameTimeMethod
<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>
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