Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT05518747
• Lead Sponsor: University of Copenhagen

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-29
• Study Start: 2022-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Placebo	Placebo	In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in microbial composition in dental plaque	Baseline vs. week 6 and week 12	Changes in alpha and beta diversity of microbial composition

Secondary Outcome Measures

Name	Time	Method
Changes in dental plaque	Baseline vs. week 6 and week 12	Changes in mean level of dental plaque
Changes in bleeding on probing	Baseline vs. week 6 and week 12	Changes in mean level of bleeding on probing
Changes in probing pocket depth	Baseline vs. week 6 and week 12	Changes in mean level of probing pocket depth
Changes in clinical attachment level	Baseline vs. week 6 and week 12	Changes in mean level of clinical attachment level
Changes in salivary levels of inflammatory cytokines	Baseline vs. week 6 and week 12	Changes in mean salivary levels of selected inflammatory cytokines

Trial Locations

Locations (1)

University of Copenhagen, Department of Odontology; 🇩🇰 Copenhagen, Denmark