Study of Colonization of Strains L.Plantarum and L.Brevis in the Product AB-DENTALAC Chewing Gum

Study Overview
=================
Brief 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: Number of patients to be randomized:40 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.

Official Title
-----------------
Oral Colonization by Lactobacillus Brevis KABP 052 (CECT 7480) and Lactobacillus Plantarum KABP 051 (CECT 7481): A Randomized, Double-Blinded, Placebo-Controlled Trial

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Dietary Supplement: AB-DENTALAC [Probiotics (study)]
* Dietary Supplement: Placebo (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men between 18-55 years. Capacity to understand the procedures and implications of the study. Gingival Index <1,5 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51) Plaque Index <2,0 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51) Periodontal pocket depth <5 mm Exclusion Criteria: Less than 20 natural teeth More than 2 untreated caries at the time of enrollment Current orthodontic or periodontal treatment Hypersensitivity or allergy to any of the ingredients of the experimental product Consumption of antibiotics in the 8 weeks prior to treatment Use of probiotics designed to improve oral health, or having consumed them during the 8 weeks prior to the study Consumption of any type of probiotic during the 4 weeks prior to the study Usual consumption of clorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days before the start of the study Pregnant or lactating women Participants with chronic diseases (eg, diabetes, kidney problems, cancer) or under chronic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>The volunteers will follow the assigned treatment for 6 weeks (PROBIOTICS_AB-DENTALAC CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers after 6 weeks. | Dietary Supplement: AB-DENTALAC [Probiotics (study)]<br>* 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).<br>|
| Placebo Comparator: Control<br>The volunteers will follow the assigned treatment for 6 weeks (PLACEBOS CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers. | Dietary Supplement: Placebo (control)<br>* Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probiotic colonization of the oral cavity (qPCR) | Quantification of L. brevis and L. plantarum by species-specific qPCR in pooled samples of saliva, dental plaque (from the CPI subset) and lingual plaque | Change from Baseline assessed 6 weeks after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of PII | Plaque Index (PlI; Silness and Löe 1964) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist. | Change from Baseline assessed 6 weeks after study entry | 
| Progression of GI | Gingival Index (GI; Löe and Silness 1963) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist. | Change from Baseline assessed 6 weeks after study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral health, Probiotics, L. plantarum, L. brevis, Periodontics, Dental plaque