mondgezondheid gum disease
Conditions
Interventions
Subjects are instructed to use one lozenge, 3 times daily after each meal, with
the probiotic Lactobacillus plantarum (group A), with the probiotic
Lactobacillus paracasei (group B) or lozenges with
Sponsors
Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Willing and able to give written informed consent and willing and able to comply to all study procedures; Adult, * 18 years - 55 years; Systemically healthy, as assessed by a medical questionnaire (no systemic diseases); Minimum of 20 natural teeth: at least the first or second molar must be present in each quadrant; Having visited the dentist for a regular check-up within the last year and having finished the necessary treatment(s);
Exclusion criteria
Exclusion criteria: ACTA dental student or ACTA employee; Participation in a clinical study within the previous 30 days; Allergy/Intolerance to the test and placebo products (ingredients) in particular lactose and milk protein content (allergens) in the test products; not having a good general health and/or oral health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the status of the gingival health of the participants: bleeding of the gingiva on marginal probing (BOMP). This will be documented to follow the gingival health status before, during and after the intervention and challenge. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks and burden related to this study are judged to be very limited. The time burden per research visit is at most 30 to 40 minutes. The induction of mild (short term, temporarily/reversible) gingival inflammation is a well-established method. The mild inflammatory status is completely reversible without long term risk or effects on dental health. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary goal of this study is to follow the dynamics of immunological (a panel of interleukins and cytokines) and microbiological (microbial composition and diversity) aspects of the oral cavity. | — |
Countries
Netherlands
Outcome results
None listed