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

Completed

Conditions: mondgezondheid
gum disease

Registration Number: NL-OMON46824

Lead Sponsor: Academisch Centrum Tandheelkunde Amsterdam (ACTA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 117

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the status of the gingival health of the<br /><br>participants: bleeding of the gingiva on marginal probing (BOMP). This will be<br /><br>documented to follow the gingival health status before, during and after the<br /><br>intervention and challenge.<br /><br>Nature and extent of the burden and risks associated with participation,<br /><br>benefit and group relatedness: The risks and burden related to this study are<br /><br>judged to be very limited. The time burden per research visit is at most 30 to<br /><br>40 minutes. The induction of mild (short term, temporarily/reversible) gingival<br /><br>inflammation is a well-established method. The mild inflammatory status is<br /><br>completely reversible without long term risk or effects on dental health.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary goal of this study is to follow the dynamics of immunological (a<br /><br>panel of interleukins and cytokines) and microbiological (microbial composition<br /><br>and diversity) aspects of the oral cavity.</p><br>