Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Recruiting
    • University of Copenhagen, Department of Odontology
    • Contact: Daniel Belstrøm, DDS, PhD; Phone Number: +45 21300580; Email: dbel@sund.ku.dk
    • Contact: Merete Markvart, DDS, PhD; Phone Number: +45 35 33 77 65; Email: mema@sund.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks	Dietary supplement: Probiotic; In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.
Placebo Comparator: Placebo; In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks	Dietary supplement: Placebo; In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microbial composition in dental plaque	Changes in alpha and beta diversity of microbial composition	Baseline vs. week 6 and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UCPH_01_007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

All microbial data will be shared, as these will be uploaded to a publically accessible database.

In accordance with GDPR, immunological and clinical data will only be shared as mean (range) values.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No