Status:
COMPLETED
Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction
Lead Sponsor:
AB Biotics, SA
Collaborating Sponsors:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Conditions:
Caries
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 random...
Detailed Description
The probiotic Streptococcus dentisani is a bacterial species present in the human oral microbial flora. It was isolated initially, as result of observation and hypothesis, of volunteers who had never ...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 and 65
- With a previous history of caries and / or active cavities
- Absence of other oral diseases
- With a basal oral pH (after brushing with only water) in saliva equal to or less than 7
Exclusion
- Antibiotic use during the 30 days prior to the start of the study.
- Usual consumption of chlorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days prior to the start of the study.
- Consumption of oral probiotics during the 30 days prior to the start of the study (Annex II)
- Pregnant or lactating women
- Participants with chronic diseases (eg diabetes, kidney problems, cancer) or who may affect the salivary flow
- Participants in chronic treatment or with medication that can reduce salivary flow, such as antidepressants or psychotropic drugs.
- Allergy to any of the ingredients of the research product
Key Trial Info
Start Date :
May 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03468842
Start Date
May 13 2016
End Date
December 20 2017
Last Update
March 19 2018
Active Locations (1)
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1
Lluis Alcanyis Foundation dental clinic, University of Valencia
Valencia, Spain, 46010