Effect of Probiotics on Oral Homeostasis During Sugar Stress

NCT05073393 | Completed DMC

• 1 other identifier: UCPH_01_005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries; Probiotics; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Changes in microbial composition in dental plaque

  Changes in alpha and beta diversity of microbial composition

  Baseline vs. Day 14 and Day 28

Secondary Outcomes (2)

• Changes in clinical parameters

  Baseline vs. Day 14 and Day 28

• Changes in salivary levels of inflammatory cytokines

  Baseline vs. Day 14 and Day 28

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Sugar stress BEHAVIORAL

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

Placebo; Probiotic

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 18 yrs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Deerland Probiotics and Enzymes: collaborator

Study Sites (1)

University of Copenhagen, Department of Odontology

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Dental Caries; Gingivitis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Dr. odont

Model Details: Double blinded randomized clinical trial with a test and placebo group

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 11, 2021
• Study Start: November 3, 2021
• Primary Completion: December 17, 2021
• Study Completion: June 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)