Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

August 22, 2022 updated by: Daniel Belstrøm, DDS, PhD, University of Copenhagen
The present study is a double-blinded randomized clinical trial with a duration of 28 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University of Copenhagen, Department of Odontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- age > 18 yrs.

Exclusion Criteria:

  • Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
  • Current smokers
  • Any systemic diseases and current use of any medication with known effect on oral health
  • Use of systemic antibiotics within the latest three months
  • Age < 18 yrs., and age > 30 yrs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
Behavioral: Oral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Placebo Comparator: Placebo
In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
Behavioral: Oral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in microbial composition in dental
Time Frame: Baseline vs. Day 14 and Day 28
Changes in alpha and beta diversity of microbial composition
Baseline vs. Day 14 and Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in clinical parameters
Time Frame: Baseline vs. Day 14 and Day 28
Changes in levels of dental plaque and gingival inflammation
Baseline vs. Day 14 and Day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in salivary levels of inflammatory cytokines
Time Frame: Baseline vs. Day 14 and Day 28
Changes in mean salivary levels of selected inflammatory cytokines
Baseline vs. Day 14 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Deerland Probiotics and Enzymes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCPH_01_006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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