Clinical trial NCT05738369: The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients
Official title: The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Keywords: White spot lesions, Probiotic lozenges, QLF
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 75
Sex: ALL
Minimum age (years): 17
Maximum age (years): 33
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm parallel design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of white spot lesions (WSL)
timeFrame: 3 months
measure: Lesion area
timeFrame: 3 months
measure: ΔF%
timeFrame: 3 months
Secondary outcomes:
measure: ΔFMax (%)
timeFrame: 3 months
measure: ΔR30 (%)
timeFrame: 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Postgraduate Dental Teaching Clinics/JUST
Study officials:
affiliation: Faculty of Dentistry/Jordan University of Science and Technology
name: Susan Al-Khateeb
role: PRINCIPAL_INVESTIGATOR
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