NCT05738369

The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients

The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 17 Years – 33 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment.

Detailed description

Background: Recently, the use of probiotics has emerged as a treatment for prevention of oral cavity diseases including periodontal problems, and initial caries. The objectives of this prospective randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment. Methods: Quantitative light induced fluorescence (QLF) images were taken for three randomly allocated groups (intervention group, n=23; positive control, n=23; negative control, n=24) of patients undergoing orthodontic treatment in three separate occasions (T0: before the start of study; T1: at 6 weeks later; T2: at 3 months after the commencement of the study). Subjects in the intervention group were instructed to take one probiotic lozenge containing two strains of Lactobacillus reuteri twice daily. Sugar-free lozenges were used in the positive control group and no lozenges for the negative control group. The QLF images were analyzed using a dedicated software in order to quantitatively analyze each tooth. The primary outcomes measured were the number of newly developed lesions in each group, lesion area and amount of mineral loss (ΔF). Means and standard deviations were calculated using the Statistical Package for the Social Science (SPSS version 28, Chicago, IL, USA). Split plot ANOVA (SPANOVA) test for repeated measures was used to check differences within and between the three groups regarding lesion area and ΔF. To check which group is different from the others, Tukey's test was used.

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biogaia L. reuteri Prodentis® lozenges	Participants were instructed to use the lozenges twice daily after brushing their teeth; once in the morning and once in the evening
DIETARY_SUPPLEMENT	Hersheyland Ice Breakers Mints sugar free lozenges	Hersheyland Ice Breakers Mints sugar free lozenges

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2023-02-22
• Last updated: 2026-04-09

Locations

1 site across 1 country: Jordan