Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04634201

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
116 (estimated)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
12 Years – 16 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOral probiotics (L. reuteri)administration of probiotic containing tablets twice daily after tooth brushing for 3 months
DIETARY_SUPPLEMENTPlaceboadministration of a placebo twice daily after tooth brushing for 3 months

Timeline

Start date
2022-03-23
Primary completion
2026-03-01
Completion
2026-03-01
First posted
2020-11-18
Last updated
2025-12-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04634201. Inclusion in this directory is not an endorsement.