Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

Study Overview
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Brief Summary
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Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)

Detailed Description
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White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups

Official Title
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Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial

Conditions
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White Spot Lesion

Intervention / Treatment
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* Device: Orthodontic treatment with clear aligner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients from both genders aged (17 - 24 years). Class I malocclusion with mild to moderate crowding (≤ 5 mm). Non-extraction treatment plan. Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis. 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 and salivary glands diseases were excluded.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 24 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clear Aligner<br>Group 1 treated with clear aligners | Device: Orthodontic treatment with clear aligner<br>* Included orthodontic treatment with clear aligner (eon Aligners)<br>|
| Active Comparator: Fixed appliance<br>Group 2 treated with conventional fixed appliances | Device: Orthodontic treatment with clear aligner<br>* Included orthodontic treatment with clear aligner (eon Aligners)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta F | Incideance of Fluorescence loss | 3 months | 
| Lesion area | Incidence of the white spot lesion area | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new lesions | The number of newly developed white spot lesion during orthodontic treatment | 3 months | 
| ΔR30 | Rate of plaque on tooth surfaces | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White spot lesion, QLF, Clear aligners