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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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White Spot Lesion

Intervention / Treatment
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* Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges
* Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients from both sexes Having full fixed orthodontic appliances with expected remaining treatment duration of at least 6 months Optimum oral hygiene Maximum of 3 restored teeth Absence of defective enamel formation in the form of hypocalcification or hypoplasia Exclusion Criteria: Patients with poor oral hygiene Defective enamel Extensive restorations Gingival hyperplasia Salivary glands diseases Smoking, alcohol consumption, mouth wash use, antibiotic or probiotic intake in the last 3 months.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm parallel design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Participants received treatment with Biogaia L. reuteri Prodentis® lozenges | Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges<br>* Participants were instructed to use the lozenges twice daily after brushing their teeth; once in the morning and once in the evening<br>|
| Placebo Comparator: Sugar free lozenges<br>Participants received Hersheyland Ice Breakers Mints sugar free lozenges | Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges<br>* Hersheyland Ice Breakers Mints sugar free lozenges<br>|
| No Intervention: Negative control<br>Participants received no lozenges or supplements | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of white spot lesions (WSL) | Number of newly developed white spot lesions | 3 months | 
| Lesion area | Surface area of the WSL (in pixels) | 3 months | 
| ΔF% | Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ΔFMax (%) | Deepest point in the lesion | 3 months | 
| ΔR30 (%) | Amount of plaque present | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White spot lesions, Probiotic lozenges, QLF