Treatment of Crowding Without Extraction Using Self Ligating Brackets

Study Overview
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Brief Summary
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This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction. The study sample will consist of 66 patients with 3-6mm crowding. The sample will be allocated randomly into two experimental groups, in addition to a control group. The brackets will be applied using indirect bonding method for all patients. The dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using CBCT radiographs; pre and post- treatment changes for each group will be evaluated individually.

Detailed Description
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Producing of modern and various brackets systems both self- ligating and conventional make the 3 dimensional important in order to evaluate the root positions and to investigate EARR in multi root teeth, so the research will depend on CBCT to carry out these purposes in our study. Beside to compare the duration of alignment among groups. Fixed appliances will be applied into three groups as 1. Active self ligating brackets (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach to wire 19*25 S.S upper and lower. During leveling, thermal activated wires will be used in all patients. CBCT images will be done before and after leveling and alignment of teeth to compare dentoalveolar changes between study groups.

Official Title
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Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT Randomized Controlled Trial

Conditions
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Crowding

Intervention / Treatment
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* Device: Traditional brackets
* Device: Active self-ligating brackets
* Device: Passive self-ligating brackets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients permanent dentition stage. crowding up to 6 mm Class I relationship. Good oral hygiene. Exclusion Criteria: Poor oral hygiene. Previous orthodontic treatment. Patients with syndromes, clefts, or craniofacial abnormalities. Class II or III skeletal anteroposterior relationship. Crowding less than 3mm and more than 6mm.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 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: Traditional brackets<br>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022 Brackets | Device: Traditional brackets<br>* Treating of crowding using traditional brackets<br>|
| Experimental: Active self-ligating brackets<br>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using active self-ligating brackets; American orthodontics active self-ligating Empower® MBT 0.022 | Device: Active self-ligating brackets<br>* Treating of crowding using active self-ligating brackets<br>|
| Experimental: Passive self-ligating brackets<br>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using passive self-ligating brackets; American orthodontics passive self-ligating Empower® MBT 0.022 | Device: Passive self-ligating brackets<br>* Treating of crowding using passive self-ligating brackets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of alignment | Speed of alignment will be measured and compared between the groups. | After 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the torque and tipping of teeth | The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images. | Evaluation before and after alignment and leveling teeth. (after 9 months) | 
| Changes of widths and depths of the dental arches | Changes of dental arches dimensions will be measured and compared between groups. | Evaluation before and after alignment and leveling teeth. (after 9 months) | 
| External apical root resorption | External apical root resorption of each tooth on CBCT images (frequencies) after treatment. | After 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crowding, Self ligating, CBCT, RCT