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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738369
• Other study ID #: JUST20220097
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 33 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exanthema
• White Spot Lesion

Intervention

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
• Hersheyland Ice Breakers Mints sugar free lozenges
Hersheyland Ice Breakers Mints sugar free lozenges

Locations

Country	Name	City	State
Jordan	Postgraduate Dental Teaching Clinics/JUST	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of white spot lesions (WSL)	Number of newly developed white spot lesions	3 months
Primary	Lesion area	Surface area of the WSL (in pixels)	3 months
Primary	?F%	Average lesion fluorescence loss (?F%) reflecting mineral loss in percent.	3 months
Secondary	?FMax (%)	Deepest point in the lesion	3 months
Secondary	?R30 (%)	Amount of plaque present	3 months