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Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction

NCT03468842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-03-19

No results posted yet for this study

Summary

Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT 7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria will be randomized and receive the corresponding treatment. The study will follow a randomized design, with two groups in parallel (placebo group and probiotic group) of prospective, double-blind follow-up, for a period of 45 days. The present study will be conducted in a single center and will include a total of 70 patients. The present study has a double main objective:

* Evaluate whether the administration of the probiotic S. dentisani CECT 7746 alkalizes the basal pH of saliva.
* Test the safety and tolerability of the probiotic

Secondary

* Evaluate other microbiological parameters associated with caries risk such as the presence of microorganisms such as S. mutans.
* Evaluate the presence in the mouth and colonization capacity of S. dentisani.
* Evaluate the lactic acid and the pH of the ex vivo plate before and after the administration of a sugar solution
* Evaluate the salivary pH before and after the administration of a sugar solution
* Evaluate the salivary pH before brushing with water.
* Evaluate the buffer capacity of saliva

Conditions

  • Caries

Interventions

BIOLOGICAL

Probiotic

Already described

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    collaborator OTHER

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Enrique Conde · Effice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-13
Primary Completion
2017-03-24
Completion
2017-12-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468842 on ClinicalTrials.gov