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Completed

NCT Number: NCT07548138

Effect of Probiotic Supplementation on Gingival Health in Orthodontic Patients

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

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Orthodontic Treatment Periodontal Diseases Stomatognathic Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Acronym: PRO-ORTHO

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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