Mandibular First Molar Distalization

Study Overview
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Brief Summary
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A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.

Detailed Description
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Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.

Official Title
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The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial

Conditions
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Class III Malocclusion

Intervention / Treatment
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* Procedure: Mandibular distalization using extra-radicular miniscrews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class III dental incisal relation. Dental canine and molar relation not more than half unit Class III. Presence of unerupted mandibular third molars on both sides. Skeletal Class I or mild Class III. Full Permanent dentition. Medically free subjects. Exclusion Criteria: Patients with systemic diseases or neuromuscular disorders. Retroclined lower incisors. Sever skeletal dysplasia. Patients with periodontal disease.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator<br>Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws. | Procedure: Mandibular distalization using extra-radicular miniscrews<br>* Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars<br>|
| Experimental: Intervention<br>Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws. | Procedure: Mandibular distalization using extra-radicular miniscrews<br>* Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental effect | Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program . Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal and soft tissue effect | Skeletal and soft tissue changes post distalization, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device