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Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

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ClinicalTrials.gov Identifier: NCT03522363
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Information provided by (Responsible Party):
AB Biotics, SA

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 11, 2018
Actual Study Start Date  ICMJE February 5, 2016
Actual Primary Completion Date March 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Streptococcus Dentisani Colonization Capacity in a Split Mouth Model
Official Title  ICMJE Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model
Brief Summary Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups that differ in the number of treament applications.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Oral Health
Intervention  ICMJE Other: Streptococcus dentisani CECT7746
Treatment will be applied topically as an adhesive gel with a dental splint
Study Arms  ICMJE
  • Experimental: Monodose group
    1 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU
    Intervention: Other: Streptococcus dentisani CECT7746
  • Experimental: Multidose group
    7 vials with 5,5E09 CFU/g Total dose treatment: 4E10 CFU
    Intervention: Other: Streptococcus dentisani CECT7746
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2018)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2016
Actual Primary Completion Date March 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522363
Other Study ID Numbers  ICMJE ABB-Sdentcolonization
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party AB Biotics, SA
Study Sponsor  ICMJE AB Biotics, SA
Collaborators  ICMJE Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators  ICMJE
Principal Investigator: Alex Mira, Dr. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
PRS Account AB Biotics, SA
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP