Effect of Probiotic Supplementation on Gingival Health in Orthodontic Patients

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07548138

Acronym

PRO-ORTHO

Enrollment

100

Registered

2026-04-23

Start date

2021-12-01

Completion date

2025-03-10

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Orthodontic Treatment

Keywords

Probiotics, Limosilactobacillus reuteri, Orthodontic treatment

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

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

Interventions

DIETARY_SUPPLEMENTProbiotic suplementation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants were randomly assigned to parallel groups receiving and not receiving probiotics

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in gingival inflammation.	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

Countries

Poland

Contacts

STUDY_CHAIRKaźmierczyk-Winciorek

Department of Integrated Dentistry, Medical University of Warsaw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026