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

SUMMARY



Rationale: In the current study we will evaluate the effectiveness of two well defined probiotic strains, Lactobacillus paracasei LPc-G110 (CCTCC M 2013691) and Lactobacillus plantarum GOS42 (DSM 32131), in strengthening the oral ecosystem. These strains were selected from a panel of probiotic strains as the first mentioned was most potent in reducing the proportions of several anaerobic genera in ex vivo oral biofilms and the second was very effective in modulating the immune response in a model for gingival immune reactions. After supplementing the oral ecosystem with these probiotics or a placebo for 14 days, we will examine the (strengthened) resilience of the oral ecosystem using a two-week experimental gingivitis model by following the dynamics of clinical, immunological and microbial parameters. After experimental gingivitis, the volunteers will resume their normal oral hygiene routine and stop using the food ingredient. Two weeks later, when the effects of the experimental gingivitis have been reversed, we will examine the oral ecosystem once more to assess to what extent the modulating effects of L. paracasei and L. plantarum on the oral microbiome/ecosystem are still present.

Objective: The primary objective is to evaluate clinically the effectiveness of two oral probiotic strains, compared with a placebo-group, on the gingival health during a two-week wash-in phase followed by a two-week period refraining from oral hygiene and a two-week wash-out phase. The secondary objective is to explore the dynamics of immunological and microbiological aspects of the oral cavity for the duration of the wash-in phase, the experimental gingivitis phase and the wash-out phase concerning the use of the two oral probiotic strains compared with the placebo-group.

Study design: This study is a single-centre, challenge intervention, double-blind, parallel group (3) randomized, placebo-controlled clinical trial.

Study population: The study population consists of 117 healthy human volunteers of 18 to 55 years old.

Food ingredient and challenge intervention: 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 without probiotics (placebo group). The challenge intervention is based on a full mouth experimental gingivitis protocol. For this, subjects will be requested to refrain from any form of oral hygiene for two weeks, resulting in plaque accumulation, temporarily leading to induction of mild gingival inflammation.

Main study parameters: 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 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.
Determination of the clinical parameters are part of standard dental clinical care. In addition, the collection of samples (saliva, plaque) during the study do not require invasive procedures. The probiotic strains, L. paracasei and L. plantarum, are present in various fermented food products and comply with the Qualified Presumption of Safety (QPS) status given by European Food Safety Authority (EFSA). Besides they are both available in many over-the-counter probiotic food ingredients targeted at gut health and oral health.

There is no direct benefit for the participants. The aim of the food ingredients is to sustain oral health in healthy individuals, therefore the effects of these ingredients are examined in an orally and systemically healthy population. As the outcomes of this study could support oral health and prevent oral disease, the very limited burden for the subjects is considered acceptable.

To evaluate the effectiveness of two well defined probiotic strains, Lactobacillus paracasei LPc-G110 (CCTCC M 2013691) and Lactobacillus plantarum GOS42 (DSM 32131), in strengthening the oral ecosystem.

6 visits during 6 weeks

3 times daily intake of probiotic lozenges during 4 weeks



two weeks no dental cleaning (brushing)