- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522363
Streptococcus Dentisani Colonization Capacity in a Split Mouth Model
Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Valencia, Spain, 46010
- Lluis Alcanyis Foundation dental clinic, University of Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monodose group
1 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU
|
Treatment will be applied topically as an adhesive gel with a dental splint
|
Experimental: Multidose group
7 vials with 5,5E09 CFU/g Total dose treatment: 4E10 CFU
|
Treatment will be applied topically as an adhesive gel with a dental splint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Streptococcus dentisani CECT 7746 colonization capacity
Time Frame: 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)
|
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
Time Frame: 0 - 14- 28 days
|
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
Time Frame: 0 - 14- 28 days
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alex Mira, Dr., Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ABB-Sdentcolonization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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