Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

Study Overview
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Brief Summary
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Atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. There are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. Refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.

Official Title
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Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)

Conditions
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Mandible; Deformity

Intervention / Treatment
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* Device: Guided biaxial alveolar distraction device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the posterior atrophic mandible. The distance from the alveolar crest to the upper border of the canal is not less than 5 mm. Adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months. Patientswithanadequateoralhygiene. The patient should be psychologically accepting of the involved procedures. Exclusion Criteria: Medically compromised patients contradicting operation (ASA III, IV & V). Patients receiving radiotherapy or chemotherapy or bisphosphonate. Bonediseases(Osteoporosis,Osteopetrosis,Osteomalacia...etc.) Any habits that might retard healing such as heavy smoking and alcoholism. A history of any grafting procedure at the designated area.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided biaxial distraction<br> | Device: Guided biaxial alveolar distraction device<br>* A crestal incision will be done, a surgical guide will be placed to assist the correct position of osteotomy, an Extraosseous alveolar distractor will be placed on the ridge to mark screw sites and then will be removed, A distractor will be stabilized to the basal segment with a monocortical screw.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain scorre | It will be assessed on daily basis for one week through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) | at 1, 7 and 14 days | 
| change in wound healing | The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent) | at 1, 7 and 14 days | 
| Change in mental nerve reflex | Mental nerve blink reflex responses to electrical stimuli given with a small bipolar pediatric stimulating electrode to the center of the mental nerve distribution on the chin and lower lip on each side will be recorded bilaterally with surface electrodes on the orbicularis oculi muscles with Viking IV EMG equipment | Baseline, after 2 weeks and 1 month | 
| Change in bone density | Bone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT | Baseline,1 month, 3 months |