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

Sponsor
Jordan University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05738369
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
14.5
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges
  • Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three arm parallel designThree arm parallel design
Masking:
Quadruple (Participant, Care Provider, 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
Primary Purpose:
Prevention
Official Title:
The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial
Actual Study Start Date :
Feb 14, 2022
Actual Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

Dietary Supplement: Biogaia 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
Placebo Comparator: Sugar free lozenges

Participants received Hersheyland Ice Breakers Mints sugar free lozenges

Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges
Hersheyland Ice Breakers Mints sugar free lozenges
No Intervention: Negative control

Participants received no lozenges or supplements

Outcome Measures

Primary Outcome Measures

  1. Incidence of white spot lesions (WSL) [3 months]

    Number of newly developed white spot lesions

  2. Lesion area [3 months]

    Surface area of the WSL (in pixels)

  3. ΔF% [3 months]

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

Secondary Outcome Measures

  1. ΔFMax (%) [3 months]

    Deepest point in the lesion

  2. ΔR30 (%) [3 months]

    Amount of plaque present

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 33 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Postgraduate Dental Teaching Clinics/JUST Irbid Jordan 22110

Sponsors and Collaborators

  • Jordan University of Science and Technology

Investigators

  • Principal Investigator: Susan Al-Khateeb, Faculty of Dentistry/Jordan University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jordan University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05738369
Other Study ID Numbers:
  • JUST20220097
First Posted:
Feb 22, 2023
Last Update Posted:
Feb 22, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jordan University of Science and Technology
White spot lesions, Probiotic lozenges, QLF
Additional relevant MeSH terms:
Exanthema

Study Results

No Results Posted as of Feb 22, 2023