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Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

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University of Copenhagen

Status

Enrolling

Conditions

Periodontitis

Treatments

Dietary Supplement: Probiotic
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05518747
UCPH_01_007

Details and patient eligibility

About

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

Full description

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks

. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.

Clinical measurements and sampling will be performed at baseline, week 6 and week 12.

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Enrollment

60 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Periodontitis stage 2-3, Grade B-C, generalized

Exclusion criteria

  • • Use of systemic antibiotics within the latest three months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Probiotic
Experimental group
Description:
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Treatment:
Dietary Supplement: Probiotic
Placebo
Placebo Comparator group
Description:
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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