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Streptococcus Dentisani Colonization Capacity in a Split Mouth Model

NCT03522363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-05-11

No results posted yet for this study

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.

Conditions

  • Oral Health

Interventions

OTHER

Streptococcus dentisani CECT7746

Treatment will be applied topically as an adhesive gel with a dental splint

Sponsors & Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    collaborator OTHER

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Alex Mira, Dr. · Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2016-03-11
Completion
2016-09-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522363 on ClinicalTrials.gov