Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

Study Overview
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Brief Summary
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The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment

Detailed Description
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Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. Materials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.

Official Title
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Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial

Conditions
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White Spot Lesion

Intervention / Treatment
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* Combination Product: Adhesive bonding systems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients from both sexes aged 17 - 25 years Mild-to-moderate crowding (≤5 mm) Optimum oral hygiene Maximum of 3 restored teeth Absence of defective enamel formation in the form of hypocalcification or hypoplasia No salivary gland diseases. Exclusion Criteria: Patients with poor oral hygiene Heavily restored teeth Sever crowding Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 25 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: Three parallel groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Three-step adhesive<br>The orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States) | Combination Product: Adhesive bonding systems<br>* Three different adhesive bonding systems were used; one system per group<br>|
| Experimental: Self-etch primer adhesive<br>The orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States). | Combination Product: Adhesive bonding systems<br>* Three different adhesive bonding systems were used; one system per group<br>|
| Experimental: One-step adhesive system<br>The orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany) | Combination Product: Adhesive bonding systems<br>* Three different adhesive bonding systems were used; one system per group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average lesion fluorescence loss (ΔF%) | It reflects mineral loss from tooth surface (in percent) | 4 months | 
| surface area of WSL | Area of mineral loss measured in pixels | 4 months | 
| Incidence of WSL | Number of newly developed WSLs | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum lesion fluorescence loss (ΔFMAX%) | It reflects the deepest area of the WSL (in percent) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-etch primer, one step adhesive, conventional bonding system