White Spot Lesion
Conditions
Keywords
White spot lesions, Probiotic lozenges, QLF
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.
Interventions
DIETARY_SUPPLEMENTBiogaia 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_SUPPLEMENTHersheyland Ice Breakers Mints sugar free lozenges
Hersheyland Ice Breakers Mints sugar free lozenges
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigated supplements were provided to the participants by a research assistant. The participants in the negative control group, however, were not blinded because they did not receive any supplements
Intervention model description
Three arm parallel design
Eligibility
Sex/Gender
ALL
Age
17 Years to 33 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| ΔF% | 3 months | Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔFMax (%) | 3 months | Deepest point in the lesion |
| ΔR30 (%) | 3 months | Amount of plaque present |
Countries
Jordan
Contacts
PRINCIPAL_INVESTIGATORSusan Al-Khateeb
Faculty of Dentistry/Jordan University of Science and Technology
Outcome results
None listed