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

February 21, 2023 updated by: Jordan University of Science and Technology

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Postgraduate Dental Teaching Clinics/JUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 33 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of white spot lesions (WSL)
Time Frame: 3 months
Number of newly developed white spot lesions
3 months
Lesion area
Time Frame: 3 months
Surface area of the WSL (in pixels)
3 months
ΔF%
Time Frame: 3 months
Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔFMax (%)
Time Frame: 3 months
Deepest point in the lesion
3 months
ΔR30 (%)
Time Frame: 3 months
Amount of plaque present
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUST20220097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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