Effect of Probiotic Supplementation on Gingival Health in Orthodontic Patients (PRO-ORTHO)

April 20, 2026 updated by: Medical University of Warsaw

Assessment of the Impact of the Probiotic Limosilactobacillus Reuteri Prodentis (DSM 17938 and ATCC PTA 5289) on Clinical and Microbiological Parameters in Orthodontically Treated Patients With Concomitant Gingivitis

This study evaluated the effect of probiotic supplementation on gingival health in orthodontic patients. Participants undergoing fixed orthodontic treatment were randomly assigned to receive either a probiotic preparation containing Limosilactobacillus reuteri or no The primary objective was to assess changes in gingival inflammation using clinical periodontal indices(BOP). Secondary outcomes included plaque accumulation(PI) . The results of this study may help determine whether probiotic supplementation can support gingival health during orthodontic treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a randomized, controlled clinical trial conducted in orthodontic patients with gingivitis. Participants were allocated to probiotic or no groups and followed for the duration of the orthodontic treatment period. Clinical periodontal parameters were recorded at baseline and at follow-up visits according to the study protocol

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Generally healthy patient
  • Age 18-59 years
  • Fixed-appliance orthodontic treatment
  • Plaque-induced gingivitis (BOP > 10%, PD ≤ 4 mm)

Exclusion Criteria:

  • Hypersensitivity to product components
  • Smoking
  • Use of any probiotics within the past 30 days
  • Antibiotic or other antimicrobial therapy within the past month
  • Use of antibacterial chlorhexidine rinses within the past 2 weeks
  • Age < 18 or > 59 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Participants receiving probiotic supplementation during orthodontic treatment
Dietary supplement: Probiotic suplementation
Participants received probiotic supplementation containing Limosilactobacillus reuteri during orthodontic treatment. The intervention was administered in an open-label manner without placebo
No Intervention: Control
Participants received standard oral hygiene instruction and professional scaling without probiotic supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gingival inflammation.
Time Frame: from baseline to 12 weeks
Gingivitis was assessed using a standardized clinical gingival index (BOP-Bleeding On Probing) during orthodontic treatment.A result above 10 percent indicates localized gingivitis, a result above 30 percent indicates generalized gingivitis. A result below 10 percent indicates healthy periodontium.The higher the percentage value, the worse the result
from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Kaźmierczyk-Winciorek, Department of Integrated Dentistry, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUM 1S8/1/Z/GW/N/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in this study, including clinical parameters (bleeding on probing, probing depth, full-mouth plaque index) and microbiological outcomes, will be shared.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and will remain available for 5 years.

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. Access will be granted after review and approval of the proposal, and a data access agreement may be required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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