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Kunnen zoetstoffen de bacteriesamenstelling in de mond verbeteren? De PROM studie

Can sweeteners encourage the growth of good bacteria? A clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23131
Enrollment
70
Registered
2019-02-05
Start date
2019-03-04
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prevention of gingival inflammation and other oral diseases

Interventions

an oral rinse of a sweetener in water, 5 carbohydrates (sweeteners) are selected and each rinse contains a 10% solution of the carbohydrate

Sponsors

ACTA Dental Research B.V.
Lead Sponsor

Eligibility

Inclusion criteria

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 year3 3. Minimum of 20 natural teeth: at least 5 evaluable teeth in each quadrant 4. 17 – 50% bleeding on probing

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Smoker 2. Overt dental caries 3. DPSI =3+ - 4 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 General health and use of medication: 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 outcomes

Primary

MeasureTime frame
microbiome composition of dental plaque and tongue swabs before and after the 2-weeks challenge

Secondary

MeasureTime frame
the amount of red fluorescent plaque (RFP) before and after the 2-weeks challenge

Contacts

Public Contactdr. C.M.C. Volgenant

ACTA

c.volgenant@acta.nl+31205980596

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)