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

Jordan University of Science and Technology

Status: Active, not recruiting

Conditions: White Spot Lesion

Treatments: Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges; Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges

Study type: Interventional

Funder types: Other

Identifiers

NCT05738369

JUST20220097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 17 to 33 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

Treatment:

Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges

Sugar free lozenges

Placebo Comparator group

Description:

Participants received Hersheyland Ice Breakers Mints sugar free lozenges

Treatment:

Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges

Negative control

No Intervention group

Description:

Participants received no lozenges or supplements