At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Lactobacillus Brevis CD2 on Traumatic Oral Lesions Induced by Fixed Orthodontic Appliance: a Randomized Clinical Trial
In Brief
A Phase 2 clinical trial evaluating L brevis and Placebo for Orthodontic Appliance Complication and 2 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.
Placebo lozenges after breakfast, lunch and dinner for 21 days.