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NCT05073393 Clinical Trial

Effect of Probiotics on Oral Homeostasis During Sugar Stress

Dental Caries Clinical Trial

Official title:
Effect of Probiotics on Oral Homeostasis During Sugar Stress

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05073393
Other study ID # UCPH_01_005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2021
Est. completion date June 1, 2022

Study information
Verified date August 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress. 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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date June 1, 2022
Est. primary completion date December 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sugar stress
Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing

Locations
Country Name City State
Denmark University of Copenhagen, Department of Odontology Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
University of Copenhagen Deerland Probiotics and Enzymes

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in microbial composition in dental plaque Changes in alpha and beta diversity of microbial composition Baseline vs. Day 14 and Day 28
Secondary Changes in clinical parameters Changes in levels of dental plaque and gingival inflammation Baseline vs. Day 14 and Day 28
Secondary Changes in salivary levels of inflammatory cytokines Changes in mean salivary levels of selected inflammatory cytokines Baseline vs. Day 14 and Day 28
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