Effect of Probiotic Supplementation on Gingival Health in Orthodontic Patients

NCT07548138 | Completed

• 1 other identifier: WUM 1S8/1/Z/GW/N/21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingivitis; Orthodontic Treatment

Keywords

Probiotics; Limosilactobacillus reuteri; Orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• Change in gingival inflammation.

  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

Study Arms (2)

Probiotic group

EXPERIMENTAL

Participants receiving probiotic supplementation during orthodontic treatment

Dietary Supplement: Probiotic suplementation

Control

NO INTERVENTION

Participants received standard oral hygiene instruction and professional scaling without probiotic supplementation

Interventions

Probiotic suplementation DIETARY_SUPPLEMENT

Participants received probiotic supplementation containing Limosilactobacillus reuteri during orthodontic treatment. The intervention was administered in an open-label manner without placebo

Probiotic group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

Location

Related Links

• The immunomodulating role of probiotics in the prevention and treatment of oral diseases

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kaźmierczyk-Winciorek

  Department of Integrated Dentistry, Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to parallel groups receiving and not receiving probiotics

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 23, 2026
• Study Start: December 1, 2021
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• 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.

Locations

PL (1)