Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

University of Copenhagen

Status: Completed

Conditions: Gingivitis

Treatments: Behavioral: Oral hygiene discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT05268757

UCPH_01_006

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).

Treatment:

Behavioral: Oral hygiene discontinuation

Placebo

Placebo Comparator group

Description:

In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).

Treatment:

Behavioral: Oral hygiene discontinuation