Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

University of Copenhagen80 enrolled

Overview

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

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 oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care. 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Gingivitis

Interventions

Oral hygiene discontinuationBEHAVIORAL

Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Copenhagen, Department of Odontology

Copenhagen, Denmark

Outcomes

Primary Outcomes

Changes in microbial composition in dental

Changes in alpha and beta diversity of microbial composition

Time frame: Baseline vs. Day 14 and Day 28

Secondary Outcomes

Changes in clinical parameters

Changes in levels of dental plaque and gingival inflammation

Time frame: Baseline vs. Day 14 and Day 28

Data from ClinicalTrials.gov

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