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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants received treatment with Biogaia L. reuteri Prodentis® lozenges |
|
| Sugar free lozenges | Placebo Comparator | Participants received Hersheyland Ice Breakers Mints sugar free lozenges |
|
| Negative control | No Intervention | Participants received no lozenges or supplements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biogaia L. reuteri Prodentis® lozenges | Dietary Supplement | Participants were instructed to use the lozenges twice daily after brushing their teeth; once in the morning and once in the evening |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ΔFMax (%) | Deepest point in the lesion | 3 months |
| ΔR30 (%) | Amount of plaque present | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Al-Khateeb | Faculty of Dentistry/Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Dental Teaching Clinics/JUST | Irbid | 22110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6758594 | Background | Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x. | |
| 15591733 | Background | Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655. |
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Data will be available upon request
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Three arm parallel design
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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
| Hersheyland Ice Breakers Mints sugar free lozenges | Dietary Supplement | Hersheyland Ice Breakers Mints sugar free lozenges |
|
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