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

NCT03468842 | Completed Phase 1

• 1 other identifier: ABB-DENTISANI-2015
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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 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

Keywords

Streptococcus dentisani; caries; salivary pH; S. mutans

Outcome Measures

Primary Outcomes (2)

• Change from baseline Salivary pH before and after brushing with wáter at 15, 30 and 45 days

  Increase in salivary pH measured on the RQflex 10 reflectometer using Reflectoquant test strips at 15, 30 and 45 days visit compared with basal value

  Through study completion, an average of 9 months

• Adverse effects

  Any adverse effect (symptom, illness or other event of medical relevance) experienced by the participant during the course of the study or detected by the physician will be recorded in the data collection notebook, regardless of whether its nature may or may not be associated with the product in study. The registry of adverse effects will detail the nature of the adverse effect, its severity, the time of appearance and duration, the actions necessary for its treatment (if necessary) and the potential relationship with the treatment of the study, as well as any other relevant information .

  Through study completion, an average of 9 months

Secondary Outcomes (8)

• Concentration of S. mutans

  Through study completion, an average of 9 months

• Concentration of S. dentisani

  Through study completion, an average of 9 months

• Lactic acid quantification before and after a sugar shock

  Through study completion, an average of 9 months

• pH quantification before and after a sugar shock

  Through study completion, an average of 9 months

• Salivary pH before and after a sugar shock

  Through study completion, an average of 9 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Composition: excipients without probiotic: 2%w/v Guam guar and 6% w/v hydroxyethilcellulose Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days

Biological: Placebo

Probiotic

ACTIVE COMPARATOR

Composition: Streptococcus dentisani: 2,5E+09CFUs, 2% (p/v) Guam Guar and 6% (p/v) Hidroxietilcelulosa. Dose of 2.5E+09 cfu/vial considering one administration every 48 hours, it will be equivalent to a dose of 1.0E+10 cfu/week Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days

Biological: Probiotic

Interventions

Probiotic BIOLOGICAL

Already described

Probiotic

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Biotics, SA: lead
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator

Study Sites (1)

Lluis Alcanyis Foundation dental clinic, University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Enrique Conde

  Effice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will follow a randomized, double-blind, placebo-controlled design with 2 parallel prospective follow-up groups.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 19, 2018
• Study Start: May 13, 2016
• Primary Completion: March 24, 2017
• Study Completion: December 20, 2017
• Last Updated: March 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)