Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

Gingivitis Clinical Trial

Official title:

Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268757
• Other study ID #: UCPH_01_006
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

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

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Odontology	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Deerland Probiotics and Enzymes

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in salivary levels of inflammatory cytokines	Changes in mean salivary levels of selected inflammatory cytokines	Baseline vs. Day 14 and Day 28
Primary	Changes in microbial composition in dental	Changes in alpha and beta diversity of microbial composition	Baseline vs. Day 14 and Day 28
Secondary	Changes in clinical parameters	Changes in levels of dental plaque and gingival inflammation	Baseline vs. Day 14 and Day 28