Effect of Probiotics on Oral Homeostasis During Sugar Stress
NCT ID: NCT05073393
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-11-03
2022-06-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic
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).
Sugar stress
Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Placebo
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).
Sugar stress
Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Interventions
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Sugar stress
Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
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Deerland Probiotics and Enzymes
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Daniel Belstrøm, DDS, PhD
DDS, PhD, Dr. odont
Locations
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University of Copenhagen, Department of Odontology
Copenhagen, , Denmark
Countries
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Other Identifiers
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UCPH_01_005
Identifier Type: -
Identifier Source: org_study_id
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