The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients
- Conditions
- White Spot Lesion
- Interventions
- Dietary Supplement: Biogaia L. reuteri Prodentis® lozengesDietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges
- Registration Number
- NCT05738369
- Lead Sponsor
- Jordan University of Science and Technology
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Biogaia L. reuteri Prodentis® lozenges Participants received treatment with Biogaia L. reuteri Prodentis® lozenges Sugar free lozenges Hersheyland Ice Breakers Mints sugar free lozenges Participants received Hersheyland Ice Breakers Mints sugar free lozenges
- Primary Outcome Measures
Name Time Method ΔF% 3 months Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.
Incidence of white spot lesions (WSL) 3 months Number of newly developed white spot lesions
Lesion area 3 months Surface area of the WSL (in pixels)
- Secondary Outcome Measures
Name Time Method ΔFMax (%) 3 months Deepest point in the lesion
ΔR30 (%) 3 months Amount of plaque present
Trial Locations
- Locations (1)
Postgraduate Dental Teaching Clinics/JUST
🇯🇴Irbid, Jordan