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Completed

NCT Number: NCT03522363

Streptococcus Dentisani Colonization Capacity 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.

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Key information

Conditions

Oral Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lluis Alcanyis Foundation dental clinic, University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Streptococcus dentisani CECT7746

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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