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Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05764187
Enrollment
51
Registered
2023-03-10
Start date
2021-12-28
Completion date
2022-12-01
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion of Tooth

Brief summary

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.

Detailed description

Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets. Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.

Interventions

OTHEROrthodontic fixed appliance therapy

Follow up of white spot lesion development using quantitative light induced fluorescence in patients bonded with ceramic brackets versus patients bonded with conventional metal brackets

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

It was not possible to mask nether the participants nor the care provider

Intervention model description

Two parallel arm randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm) * No previous orthodontic treatment * Optimum oral hygiene * Maximum of 3 restored teeth * Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion criteria

* Subjects with poor oral hygiene * Defective enamel * Patients with syndromes and Oro-facial anomalies or salivary glands diseases

Design outcomes

Primary

MeasureTime frameDescription
Lesion area4 monthsSurface area of the lesion measured in Pixels
Mean fluorescence loss ∆F(%)4 monthsMean lesion fluorescence loss reflecting mineral loss measured in percent
Maximum fluorescence loss ∆Fmax(%)4 monthsDeepest point of the lesion
Incidence of white spot lesions4 monthsThe number of newly developed white spot lesions

Secondary

MeasureTime frameDescription
Plaque measurement4 monthsAmount of plaque around the orthodontic fixed appliance

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026