Effect of Probiotics on Oral Homeostasis During Sugar Stress

Not Applicable

Completed

• Conditions: Dental Caries; Probiotics; Gingivitis
• Interventions: Behavioral: Sugar stress

• Registration Number: NCT05073393
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-11
• Study Start: 2021-11-03
• Primary Completion: 2021-12-17
• Study Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Sugar stress	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).
Placebo	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).

Primary Outcome Measures

Name	Time	Method
Changes in microbial composition in dental plaque	Baseline vs. Day 14 and Day 28	Changes in alpha and beta diversity of microbial composition

Secondary Outcome Measures

Name	Time	Method
Changes in salivary levels of inflammatory cytokines	Baseline vs. Day 14 and Day 28	Changes in mean salivary levels of selected inflammatory cytokines
Changes in clinical parameters	Baseline vs. Day 14 and Day 28	Changes in levels of dental plaque and gingival inflammation

Trial Locations

Locations (1)

University of Copenhagen, Department of Odontology; 🇩🇰 Copenhagen, Denmark