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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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White Spot Lesion of Tooth

Intervention / Treatment
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* Other: Orthodontic fixed appliance therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel arm randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceramic orthodontic brackets<br>Patients bonded with ceramic brackets for orthodontic treatment | Other: Orthodontic fixed appliance therapy<br>* 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<br>|
| Active Comparator: Metal orthodontic brackets<br>Patients bonded with metal brackets for orthodontic treatment | Other: Orthodontic fixed appliance therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion area | Surface area of the lesion measured in Pixels | 4 months | 
| Mean fluorescence loss ∆F(%) | Mean lesion fluorescence loss reflecting mineral loss measured in percent | 4 months | 
| Maximum fluorescence loss ∆Fmax(%) | Deepest point of the lesion | 4 months | 
| Incidence of white spot lesions | The number of newly developed white spot lesions | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque measurement | Amount of plaque around the orthodontic fixed appliance | 4 months |