Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AB Biotics, SA
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Adverse effects
Study Overview
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
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 developed caries. These strains have demonstrated, through in vitro studies, an enormous potential of inhibition against S. mutans, besides inhibiting the growth of other pathogens commonly present in common oral pathologies (gingivitis, periodontitis or halitosis). The probiotic product has been shown to be effective in in vitro experiments, artificial mouth models and epidemiological data, statistically significant. However, it is necessary to document the efficacy of Streptococcus dentisani in an oral application study.
Recruitment visit:
In a first visit, it will be assessed if the candidates meet all the inclusion criteria and none of the exclusion criteria. For this, a dental revision will be carried out to assess the different parameters (plaque index, gingival index and salivary flow among others), and a saliva sample will be taken after brushing with water to determine its basal pH.
Those participants who meet the criteria and provide written informed consent will be assigned to one of the two treatment groups (probiotic or placebo). The assignment will be done randomly using a computer generated list.
In this first visit, an impression of the jaw will also be made of those volunteers who meet the criteria and have been randomized. This impression will be used to manufacture custom splints that allow a more comfortable application of the treatment during the study by the participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Placebo
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
Intervention: Placebo (Biological)
Probiotic
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
Intervention: Probiotic (Biological)
Outcomes
Primary Outcomes
Adverse effects
Time Frame: Through study completion, an average of 9 months
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 .
Change from baseline Salivary pH before and after brushing with wáter at 15, 30 and 45 days
Time Frame: Through study completion, an average of 9 months
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
Secondary Outcomes
- 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)
- Plaque(Through study completion, an average of 9 months)
- Buffer capacity of the saliva(Through study completion, an average of 9 months)
- Concentration of S. mutans(Through study completion, an average of 9 months)
- Salivary pH before and after a sugar shock(Through study completion, an average of 9 months)
- Caries(Through study completion, an average of 9 months)