Acceleration of Alignment of Crowded Lower Anterior Teeth

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 included. Then, initial diagnostic records (diagnostic gypsum models, 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 two groups of patients with moderate crowding of the lower anterior teeth First group (Experimental): the patients in this group will be treated with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in order to induce remodeling of the bony structures and enhance orthodontic movement. Second group (Control): the patients in this group will be treated using fixed appliances with any acceleration method.

Official Title
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Evaluation of the Efficacy of Periodontally Accelerated Osteogenic Orthodontics in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Two-Arm Randomized Controlled Clinical Trial

Conditions
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Malocclusion, Angle Class I, Crowded Teeth

Intervention / Treatment
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* Procedure: periodontally accelerated osteogenic orthodontics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I malocclusion with moderate crowding (4-6 mm of tooth-size-arch-length-discrepancy). Good oral hygiene and periodontal health. No severe skeletal discrepancy. Normal inclination for the upper and lower incisors. No congenitally missing or extracted teeth (except for the third molars). Exclusion Criteria: Bi-maxillary severe dental protrusion. Previous orthodontic treatment. Subject with psychological abnormalities. Subject with systemic diseases.

Ages Eligible for Study
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Minimum Age: 18 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: Periodontally accelerated osteogenic orthodontics<br>Patients in this group will undergo orthodontic treatment plus periodontally accelerated osteogenic orthodontics in order to induce tooth movement. | Procedure: periodontally accelerated osteogenic orthodontics<br>* Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement<br>* Other names: PAOO;|
| No Intervention: Traditional orthodontics<br>Patients in this group will undergo traditional orthodontics without any surgical interventions | |

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 | The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 5 to 6 months | 
| Change in Little's Index of Irregularity | The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment. | T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months | 
| Change in Alveolar Defect | Using cone-beam computed tomography (CBCT), each tooth root will be evaluated in axial and cross-sectional slices at the buccal and lingual surfaces. When no cortical bone is observed around the root in at least three sequential views, this will be considered an alveolar defect. If the alveolar bone height is more than 2 mm from the cemento-enamel junction, it will be classified as dehiscence ,When the defect does not involve the alveolar crest, this case will be classified as fenestration. The status of the alveolar bone will be assessed twice. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inter-canine width | The distance between the cusp tips of the lower 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 | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 
| Change in Alveolar Bone Thickness | Will be measured for each of the lower anterior teeth in the cervical, middle, and apical regions. This will be achieved by using the ruler which will be positioned perpendicular to tooth long axis from the root surface (without measuring the periodontal ligament ) to the most external surface of the cortical bone. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 
| Change in Lower Incisors' Inclination | The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 
| Change in the positioning of the upper lip | It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion). The distance of the upper lip from this line is a measure of lip positioning. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 
| Change in the positioning of the lower lip | It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion). The distance of the lower lip from this line is a measure of lower lip positioning. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months | 
| Change in the naso-labial angle | It is the angle formed between the lower border of the nose and the upper lip. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months |