drugset / Trial / NCT04398511

L Brevis for Traumatic Oral Lesions in Orthodontic Patients

NCT04398511 ↗

RandomizedParallel-groupTriple-blindPrevention

Summary

Introduction: Traumatic oral lesions are common in the beginning of the orthodontic treatment, and pathogenic oral bacteria might be involved. We tested whether the probiotic Lactobacillus brevis CD2 (L brevis) is benefic in this condition. Methods: In a double-blind clinical trial, 20 patients were randomized to 21 days course of lozenges containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch and dinner) or placebo, starting on the day of installation of the fixed orthodontic appliance. Main outcomes were days without oral lesions and oral pain score \[ranging between 0 (no pain) and 10 (maximum)\]. Oral health related quality of life was measured by OHIP-14 before and after treatments.

Timeline

Start
2019-01-07
Primary completion
2019-11-29
Completion
2019-12-13

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus brevis CD2 Other / unclassified 4e+09 cells Oral