gingivitis gum disease
Conditions
Interventions
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 fr
Sponsors
ACTA Dental Research B.V.
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
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:
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Additionally, changes in microbial diversity (species richness, Shannon diversity index), red fluorescing plaque (RFP) and gingival bleeding on marginal probing (BOMP) will be assessed. | — |
Countries
Netherlands
Outcome results
None listed