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

NCT05738369 | Completed

• 1 other identifier: JUST20220097
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion

Keywords

White spot lesions, Probiotic lozenges, QLF

Outcome Measures

Primary Outcomes (3)

• Incidence of white spot lesions (WSL)

  Number of newly developed white spot lesions

  3 months

• Lesion area

  Surface area of the WSL (in pixels)

  3 months

• ΔF%

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

  3 months

Secondary Outcomes (2)

• ΔFMax (%)

  3 months

• ΔR30 (%)

  3 months

Study Arms (3)

Probiotic

EXPERIMENTAL

Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges

Sugar free lozenges

PLACEBO COMPARATOR

Participants received Hersheyland Ice Breakers Mints sugar free lozenges

Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges

Negative control

NO INTERVENTION

Participants received no lozenges or supplements

Interventions

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

Probiotic

Hersheyland Ice Breakers Mints sugar free lozenges DIETARY_SUPPLEMENT

Hersheyland Ice Breakers Mints sugar free lozenges

Sugar free lozenges

Eligibility Criteria

• Age: 17 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Postgraduate Dental Teaching Clinics/JUST

Irbid, 22110, Jordan

Location

Related Publications (30)

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Study Officials

• Susan Al-Khateeb

  Faculty of Dentistry/Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three arm parallel design

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 22, 2023
• Study Start: February 14, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)