Skip to content

De beoordeling van de effectiviteit van twee probiotica bij het in stand houden van de mondgezondheid: een praktijkonderzoek.

The clinical evaluation of the effectiveness of two oral probiotic strains on gingival health.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25529
Enrollment
117
Registered
2018-04-11
Start date
2018-05-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Experimental gingivitis model Probiotics Bleeding on marginal probing Microbiome Oral health Probiotica Mondgezondheid Tandvleesontsteking

Interventions

3 times daily intake of probiotic lozenges during 4 weeks two weeks no dental cleaning (brushing)

Sponsors

Ir. W. Th. Fokkema ACTA Dental Research B.V. (ADR) Gustav Mahlerlaan 3004 1081 LA Amsterdam, NL w.fokkema@acta.nl / +31 6 28 724 788
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing and able to give written informed consent and willing and able to comply to all study procedures; 2. Adult, ≥ 18 years - 55 years; 3. Male and female; 4. Systemically healthy, as assessed by a medical questionnaire (no systemic diseases); 5. Minimum of 20 natural teeth: at least the 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);

Exclusion criteria

Exclusion criteria: 1. Not meeting the inclusion criteria; 2. ACTA dental student or ACTA employee; 3. Participation in a clinical study within the previous 30 days; 4. Allergy/Intolerance to the test and placebo products (ingredients) in particular lactose and milk protein content (allergens) in the test products; General health and use of medication: 5. Smokers, definition non-smoker: <1 cigarette every day for at least one year (e-cigarettes will also be excluded); 6. Abuse of drugs or alcohol; 7. Self-reported pregnancy or breastfeeding; 8. Use of antibiotics during the last 3 months; 9. Need of antibiotic prophylaxis prior to dental treatment; 10. Use of anti-inflammatory drugs on a regular basis; 11. Evidence of any systemic disease or compromised health condition, including: a. Diabetes mellitus; b. Bronchitis, tonsillitis or sinusitis; 12. Severe oral- or pharyngeal infections; 13. Current disorders/disease resulting in (self-induced) vomiting; 14. Reduced salivary flow due to pathological reasons (e.g., Sjögren syndrome); 15. Adverse medical history or long-term medication; 16. Prescribed medication (except for contraceptives); 17. Willing not to consume any other probiotic or yoghurt products during the study;

Design outcomes

Primary

MeasureTime frame
Bleeding on marginal probing

Secondary

MeasureTime frame
Microbiome composition

Contacts

Public ContactS.V. van der Waal

Academisch Centrum Tandheelkunde Amsterdam,

s.vd.waal@acta.nl0031205980880

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)