Back to resultsEffect of Probiotics on Oral Homeostasis During Sugar Stress
Primary Purpose
Dental Caries, Probiotics, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sugar stress
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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.
Sites / Locations
- University of Copenhagen, Department of Odontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress).
In this group participants will receive placebo twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress).
Outcomes
Primary Outcome Measures
Changes in microbial composition in dental plaque
Changes in alpha and beta diversity of microbial composition
Secondary Outcome Measures
Changes in clinical parameters
Changes in levels of dental plaque and gingival inflammation
Changes in salivary levels of inflammatory cytokines
Changes in mean salivary levels of selected inflammatory cytokines
Full Information
NCT ID
NCT05073393
First Posted
October 8, 2021
Last Updated
August 22, 2022
Sponsor
University of Copenhagen
Collaborators
Deerland Probiotics and Enzymes
1. Study Identification
Unique Protocol Identification Number
NCT05073393
Brief Title
Effect of Probiotics on Oral Homeostasis During Sugar Stress
Official Title
Effect of Probiotics on Oral Homeostasis During Sugar Stress
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Deerland Probiotics and Enzymes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Probiotics, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized clinical trial with a test and placebo group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this group participants will receive placebo twice a day (morning and evening) for at period of 28 days (14 days with sugar stress followed by 14 days without sugar stress).
Intervention Type
Behavioral
Intervention Name(s)
Sugar stress
Intervention Description
Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Primary Outcome Measure Information:
Title
Changes in microbial composition in dental plaque
Description
Changes in alpha and beta diversity of microbial composition
Time Frame
Baseline vs. Day 14 and Day 28
Secondary Outcome Measure Information:
Title
Changes in clinical parameters
Description
Changes in levels of dental plaque and gingival inflammation
Time Frame
Baseline vs. Day 14 and Day 28
Title
Changes in salivary levels of inflammatory cytokines
Description
Changes in mean salivary levels of selected inflammatory cytokines
Time Frame
Baseline vs. Day 14 and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Copenhagen, Department of Odontology
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Probiotics on Oral Homeostasis During Sugar Stress
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