Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

Study Overview
=================
Brief Summary
-----------------
Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.

Detailed Description
-----------------
Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the number of applications of probiotic: Group A: participants who will receive a single application of the product during the initial visit Group B: participants who will receive 7 applications on consecutive days, with the first in the start visit. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes.The total dose received will be the same for both groups, and the total duration of the follow-up will be of 4 weeks from the first application also for both groups. On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the participants will receive an professional teeth cleaning in one half of the mouth (quadrants 1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and the randomized participants in the multiple-dose group will be explained how to perform the six successive applications at home every 24 hours. On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants. Patient assigned to the multi-dose group will return the used material On day 28th: final visit, saliva and plaque samples will be obtained.

Official Title
-----------------
Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model

Conditions
-----------------
Oral Health

Intervention / Treatment
-----------------
* Other: Streptococcus dentisani CECT7746


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absence of serious periodontal diseases (eg gingivitis, periodontitis) Ability to understand the requirements and implications of the study Exclusion Criteria: Antibiotic consumption during the 30 days prior to the initiation of the study. Oral probiotics consumption during the 30 days before the start of the study Pregnant or lactating women Chronic diseases (eg, diabetes, kidney problems, cancer) or diseases that could affect salivary flow. Chronic treatment or medication that could reduce salivary flow, such as antidepressants or psychotropic drugs. Allergy to any of the product composition ingredients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups that differ in the number of treament applications.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monodose group<br>1 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU | Other: Streptococcus dentisani CECT7746<br>* Treatment will be applied topically as an adhesive gel with a dental splint<br>|
| Experimental: Multidose group<br>7 vials with 5,5E09 CFU/g Total dose treatment: 4E10 CFU | Other: Streptococcus dentisani CECT7746<br>* Treatment will be applied topically as an adhesive gel with a dental splint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streptococcus dentisani CECT 7746 colonization capacity | Demonstrate the ability of Streptococcus dentisani CECT 7746 to adhere, colonize and remain in the dental surface after its application, with or without previous professional oral cleaning | A measure to see the change in the Baseline Streptococcus dentisani adherence will be made in V1 and V2 (14 days and 28 days after the treatment beginning, respectivetly) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streptococcus mutans concentration | To evaluate if the administration of the probiotic S. dentisani CECT 7746 reduces the amount of oral Streptococcus mutans. | 0 - 14- 28 days | 
| Oral acid production | To evaluate if the administration of the S. dentisani CECT 7746 reduces the amount of acid produced after an oral sugar solution administration | 0 - 14- 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral health, Streptococcus dentisani