Study of Colonization of Strains L.Plantarum and L.Brevis in the Product AB-DENTALAC Chewing Gum
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Study will follow a randomized, double-blind, placebo-controlled design with two groups in
      parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different
      posology models (daily consumption of probiotic gum, with or without previous professional
      oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control,
      caries, halitosis, etc.), as a non-invasive natural therapy.
    

Detailed description: 
      The study will follow a randomized, double-blind, placebo-controlled design with two groups
      in parallel, for the evaluation of two different posology models (daily consumption of
      probiotic gum, with or without previous professional oral cleaning). Probiotics have recently
      been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a
      non-invasive natural therapy.

      The aim of this study is to assess whether the daily consumption of AB-DENTALAC gum allows
      the colonization of strains L.plantarum KABP051 (CECT7481) and L.brevis KABP052 (CECT7480) in
      the oral microbiota, and to confirm the absence of side effects, with the following setup:

        1. Number of patients to be randomized:40

        2. Number of visits per patient: 2

      The study will determine the index of plaque and gingival index as a measure of oral health.
      The presence of Lactobacillus in the samples collected by qPCR will also be quantified.

      The patient will benefit from a buccal revision and control by a periodontist for 6 weeks. It
      will also help subsequent patients to obtain a better treatment (if the results are
      significant). No harm is expected to participate, it is a minimal risk study, with
      non-invasive exploratory tests and a product suitable for human consumption and marketed in
      Europe since 2012.

      The potential patients to participate in the study will be healthy patients, so if they do
      not wish to participate they will not need alternative treatment. The objective of the study
      is to see if the probiotic is able to colonize the mouth in healthy patients, it is not a
      study to demonstrate the effectiveness of the product.

      If there is any serious adverse effect (something totally unexpected being a product with
      probiotic strains QPS), the patient will be advised to stop taking the product immediately.
      It is not anticipated that the use of any additional treatment is necessary.

      The promoter will provide all the necessary material for the study: 60 cases of placebo
      chewing gum, 60 cases of probiotic chewing gum, and cleaning material (toothbrush and
      fluoridated toothpaste) for all patients.

      Statistical analysis of bacterial colonization will be performed using Student's T with
      logarithmic transformation of data if required, considering a two-tailed P <0.05 as
      significance cut-off.
    

Intervention name(s): AB-DENTALAC [Probiotics (study)]; Placebo (control)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening).; Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will follow a randomized, double-blind, split-mouth, placebo-controlled design with two parallel prospective follow-up groups for the evaluation of two different posology models (with or without previous professional oral cleaning).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oral health; Probiotics; L. plantarum; L. brevis; Periodontics; Dental plaque