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Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Oral Health Other: Streptococcus dentisani CECT7746 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Official Title: Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model
Actual Study Start Date : February 5, 2016
Actual Primary Completion Date : March 11, 2016
Actual Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Monodose group
1 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU
Other: Streptococcus dentisani CECT7746
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
Other: Streptococcus dentisani CECT7746
Treatment will be applied topically as an adhesive gel with a dental splint




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522363


Locations
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Spain
Lluis Alcanyis Foundation dental clinic, University of Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
AB Biotics, SA
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators
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Principal Investigator: Alex Mira, Dr. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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Responsible Party: AB Biotics, SA
ClinicalTrials.gov Identifier: NCT03522363    
Other Study ID Numbers: ABB‐Sdentcolonization
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Biotics, SA:
oral health
Streptococcus dentisani