L Brevis for Traumatic Oral Lesions in Orthodontic Patients

May 20, 2020 updated by: Fernando Fornari, Universidade de Passo Fundo

The Effect of Lactobacillus Brevis CD2 on Traumatic Oral Lesions Induced by Fixed Orthodontic Appliance: a Randomized Clinical Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study protocol After signing the informed consent form, the patients underwent an oral examination and answered about clinical information, oral pain scale, and the OHIP-14 questionnaire. The pain scale was graded between 0 (no pain) and 10 (maximum), Likert standard. There was also a drawing for the distribution of coded treatments, through a number taken by the patient from a manila envelope. After the orthodontic appliance installation session, each patient was instructed to use the coded treatment for the next 21 days, two gums after breakfast, after lunch and after dinner, totalizing 12 billion UFC of L brevis or placebo per day. The patient was provided with a diary to note the daily appearance of lesions and their evolution during the 21-day period, as well as the occurrence of any new symptoms (potential adverse effect), in addition to proof of the commitment assumed by the use of the tablets. After 21 days, each patient was reexamined by the author of the study, who collected the diaries and obtained information regarding the oral examination, oral pain scale, data on adherence to treatment and self-completion of the OHIP-14.

Statistical analysis Quantitative data are described with mean and standard deviation (or standard error of the mean) or median and range, while qualitative data are displayed with absolute and relative frequencies. Student's t-test was used for comparison of quantitative data between groups, Wilcoxon-Mann-Whitney (WMW) test being employed when the assumptions for that test were not met. Exact chi-square and Fisher´s exact test (FET) were used for categorical data. Treatment effect on OHIP-14 was analyzed using a Generalize Estimating Equations (GEE) model with Poisson distribution and log link, the predictors being treatment, time (beginning and end of treatment) and interaction treatment*time. The analyses were performed with softwares GraphPrism version 4.0 and SPSS® (IBM SPSS statistics v18). Sample size was estimated using WinPEPI v11.65. The P value indicative of significance was < 0.05. Because the final outcome was prevention or mitigation (not maintenance or augmentation) of undesirable symptoms, one-tailed tests were used for comparisons between groups respect to days without oral lesions, oral pain and OHIP-14 scores.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Passo Fundo, Brazil, 99052-900
        • Post-Graduate Program in Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • need for orthodontic treatment with fixed appliance

Exclusion Criteria:

  • Oral lesions
  • Uncompensated systemic diseases
  • Regular use of corticoids, antibiotics, immuno regulators and antidepressive agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L brevis
Lactobacillus brevis CD2 in lozenges containing 4 billion CFU. Patients used a lozenge 15 min after breakfast, lunch and dinner, during 21 days, starting in the day of installation of the orthodontic appliance.
Drug: L brevis
Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.
Other Names:
  • Oral probiotic
Placebo Comparator: Placebo
Placebo in lozenges, identical to those of L brevis. Patients used a lozenge 15 min after breakfast, lunch and dinner, during 21 days, starting in the day of installation of the orthodontic appliance.
Drug: Placebo
Placebo lozenges after breakfast, lunch and dinner for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days without traumatic oral lesions
Time Frame: First 21 days after appliance installation
Oral lesions (ulcers) due to fixed orthodontic appliance
First 21 days after appliance installation
Oral pain scale
Time Frame: First 21 days after appliance installation
Oral pain score measured by Likert scale between 0 (no pain) and 10 (maximum pain)
First 21 days after appliance installation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade de Passo Fundo

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Principal Investigator: Fernando Fornari, Prof., University of Passo Fundo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

May 16, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Passo Fundo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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