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L Brevis for Traumatic Oral Lesions in Orthodontic Patients

NCT04398511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-05-21

No results posted yet for this study

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.

Conditions

  • Orthodontic Appliance Complication
  • Oral Mucositis
  • Bacterium; Agent

Interventions

DRUG

L brevis

Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.

DRUG

Placebo

Placebo lozenges after breakfast, lunch and dinner for 21 days.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Universidade de Passo Fundo

    lead OTHER

Principal Investigators

  • Fernando Fornari, Prof. · University of Passo Fundo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT04398511 on ClinicalTrials.gov