L Brevis for Traumatic Oral Lesions in Orthodontic Patients

NCT ID: NCT04398511

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-12-13

Brief 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.

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.

Conditions

Orthodontic Appliance Complication; Oral Mucositis; Bacterium; Agent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

L brevis

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

L brevis

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Oral probiotic

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Universidade de Passo Fundo

OTHER

Sponsor Role: lead

Responsible Party

Fernando Fornari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Fornari, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Passo Fundo

Locations

Post-Graduate Program in Dentistry

Passo Fundo, , Brazil

Countries

Brazil

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Other Identifiers

University of Passo Fundo

Identifier Type: -

Identifier Source: org_study_id