Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion

Study Overview
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Brief Summary
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Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth: Group 1 : Patients will be treated using self-ligating brackets Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy. Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth) At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.

Detailed Description
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The sample of this study will be chosen according the following steps: The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial. A random sample of 100 patients from the sampling frame will be chosen. An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate. A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.

Official Title
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An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial

Conditions
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Malocclusion of Anterior Teeth

Intervention / Treatment
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* Device: Self-Ligating Brackets
* Device: Traditionally-Ligated Brackets
* Procedure: Corticotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of patients: 17-28 years. Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction. The Little's Index of Irregularity is over 7 mm. There is no previous orthodontic treatment. The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...). The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963). Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship. Overbite is between 0-4 mm. There is no skeletal constriction on the upper jaw. Full presence of all permanent teeth in the dental arch (except for third molars) Exclusion Criteria: Any systemic diseases that would affect tooth movement . Any congenital syndromes or cleft lip and palate cases Bad oral health

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 28 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: Self-Ligating Brackets<br>Patients will be treated using self-ligating brackets to achieve proper alignment of teeth | Device: Self-Ligating Brackets<br>* These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.<br>* Other names: SLBs;|
| Experimental: Self-Ligating Brackets with Corticotomy<br>Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment. | Device: Self-Ligating Brackets<br>* These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.<br>* Other names: SLBs;Procedure: Corticotomy<br>* Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.<br>* Other names: Decortication;|
| Active Comparator: Traditionally-Ligated Brackets<br>Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth | Device: Traditionally-Ligated Brackets<br>* These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.<br>* Other names: Non-SLBs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Alignment | The time required in days will be calculated from the beginning of treatment till the end of the alignment stage | This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months) | 
| Change in Little's Index | The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is. | T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months) | 
| Change in inter-canine width lingually | The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | 
| Change in inter-canine width | The distance between the cusp tips of the upper canines. This variable will be measured on plaster models. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | 
| Change in Canine Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | 
| Change in Lateral Incisor Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | 
| Change in Central Incisor Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) |