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Completed

NCT Number: NCT05738369

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

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.

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Key information

Conditions

Age range

17 year–33 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Dental Teaching Clinics/JUST

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Hersheyland Ice Breakers Mints sugar free lozenges

Dietary Supplement

Hersheyland Ice Breakers Mints sugar free lozenges

Primary outcomes

  1. Incidence of white spot lesions (WSL)

    Time frame: 3 months

    Number of newly developed white spot lesions

  2. Lesion area

    Time frame: 3 months

    Surface area of the WSL (in pixels)

  3. ΔF%

    Time frame: 3 months

    Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.

Secondary outcomes

  1. ΔFMax (%)

    Time frame: 3 months

    Deepest point in the lesion

  2. ΔR30 (%)

    Time frame: 3 months

    Amount of plaque present

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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