L Brevis for Traumatic Oral Lesions in Orthodontic Patients
Condition: Orthodontic Appliance Complication; Oral Mucositis; Bacterium; Agent
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): L brevis; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Oral probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fixed orthodontic appliance; Lactobacillus brevis CD2; Oral pain; Traumatic oral lesions