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Effect of Probiotics on the Periodontal Status of Orthodontic Patients

NCT04634201 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-22

No results posted yet for this study

Summary

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances

Conditions

  • Periodontal Health
  • Gingivitis

Interventions

DIETARY_SUPPLEMENT

Oral probiotics (L. reuteri)

administration of probiotic containing tablets twice daily after tooth brushing for 3 months

DIETARY_SUPPLEMENT

Placebo

administration of a placebo twice daily after tooth brushing for 3 months

Sponsors & Collaborators

  • Sunstar, Inc.

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Kevimy AGOSSA · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634201 on ClinicalTrials.gov