Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model

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.

Study Overview

• Status: Completed
• Conditions: Oral Health
• Intervention / Treatment: Other: Streptococcus dentisani CECT7746

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: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Lluis Alcanyis Foundation dental clinic, University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Streptococcus dentisani CECT 7746 colonization capacity	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	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	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: AB Biotics, SA
• Collaborators: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• 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): February 5, 2016
• Primary Completion (Actual): March 11, 2016
• Study Completion (Actual): September 20, 2016

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: oral health; Streptococcus dentisani
• Other Study ID Numbers: ABB-Sdentcolonization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No