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Completed

NCT Number: NCT05073393

Effect of Probiotics on Oral Homeostasis During Sugar Stress

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

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Key information

Conditions

Dental Caries Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Probiotics Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Odontology

Copenhagen, 2200, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Sugar stress

Behavioral

Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing

Primary outcomes

  1. Changes in microbial composition in dental plaque

    Time frame: Baseline vs. Day 14 and Day 28

    Changes in alpha and beta diversity of microbial composition

Secondary outcomes

  1. Changes in clinical parameters

    Time frame: Baseline vs. Day 14 and Day 28

    Changes in levels of dental plaque and gingival inflammation

  2. 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Deerland Probiotics and Enzymes

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Aug 23, 2022

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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