Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase

Study Overview
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Brief Summary
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This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.

Detailed Description
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The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.

Official Title
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Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase

Conditions
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Irregular Teeth

Intervention / Treatment
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* Device: Lingual brackets
* Device: Labial brackets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I malocclusion Completed permanent dentition Crowding ≥ 6 mm Exclusion Criteria: Tooth loss or extraction except third molars Having cross bite Having genetic or hormonal disorder Using a chronic drug Previous orthodontic treatment and prosthetic restoration Inappropriate oral hygiene and periodontal diseases

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lingual brackets<br>Patients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany) | Device: Lingual brackets<br>* A type of bracket that applied lingual surface of teeth.<br>* Other names: Customized lingual brackets;Device: Labial brackets<br>* A type of bracket that applied labial surface of teeth.<br>* Other names: Conventional labial brackets;|
| Experimental: Labial brackets<br>Patients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA | Device: Lingual brackets<br>* A type of bracket that applied lingual surface of teeth.<br>* Other names: Customized lingual brackets;Device: Labial brackets<br>* A type of bracket that applied labial surface of teeth.<br>* Other names: Conventional labial brackets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irregularity index (mm) | Crowding of anterior teeth changes after alignment | 18 weeks | 
| Distance between canine teeth (mm) | Measurement from right canine to left canine distance | 18 weeks | 
| Distance between first premolar teeth (mm) | Measurement from right first premolar to left first premolar distance | 18 weeks | 
| Distance between second premolar teeth (mm) | Measurement from right first premolar to left first premolar distance | 18 weeks | 
| Distance between first molar teeth (mm) | Measurement from right first molar to left first molar distance | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arch length (mm) | Measurement of arch length from mesial side of right first molar to messiah side of left first molar | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Customized lingual brackets, lingual orthodontics, digital model