Effect of Probiotics on Oral Homeostasis During Sugar Stress

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05073393
• Collaborator: Deerland Probiotics and Enzymes (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries; Probiotics; Gingivitis	Behavioral: Sugar stress	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blinded randomized clinical trial with a test and placebo groupDouble blinded randomized clinical trial with a test and placebo group
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
• Primary Purpose: Prevention
• Official Title: Effect of Probiotics on Oral Homeostasis During Sugar Stress
• Actual Study Start Date: Nov 3, 2021
• Actual Primary Completion Date: Dec 17, 2021
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: Sugar stress; Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
Placebo Comparator: 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).	Behavioral: Sugar stress; Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing

Outcome Measures

Primary Outcome Measures

1. 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

1. Changes in clinical parameters [Baseline vs. Day 14 and Day 28]

   Changes in levels of dental plaque and gingival inflammation

2. Changes in salivary levels of inflammatory cytokines [Baseline vs. Day 14 and Day 28]

   Changes in mean salivary levels of selected inflammatory cytokines

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Copenhagen, Department of Odontology	Copenhagen		Denmark	2200

Sponsors and Collaborators

• University of Copenhagen
• Deerland Probiotics and Enzymes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Belstrøm, DDS, PhD, DDS, PhD, Dr. odont, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT05073393
• Other Study ID Numbers: UCPH_01_005
• First Posted: Oct 11, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gingivitis; Dental Caries

Study Results

No Results Posted as of Aug 23, 2022