Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation

Study Overview
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Brief Summary
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Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using implants is subject to anatomical, surgical, and biological difficulties. In many cases, the bone is severely atrophied that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve (IAN). IANL is defined as the lateralization of inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of the incisive nerve; exposure and traction are used to deflect the IAN laterally while the implants are placed.

Detailed Description
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This prospective randomized clinical trial will enroll 20 patients with posterior mandibular ridge atrophy. Ten of which will undergo computer guided nerve lateralization with subsequent implant placement and repositioning of the osteomotized bone window and ten patients will undergo computer guided nerve lateralization with subsequent implant placement and sticky bone grafting.

Official Title
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Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation: A Randomized Controlled Clinical Trial

Conditions
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Posterior Atrophic Mandible, Inferior Alveolar Nerve, Nerve Lateralization

Intervention / Treatment
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* Procedure: Guided inferior Alveolar Nerve lateralization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from unilateral posterior mandibular edentulism and having < 8 mm of bone above the mandibular canal. The width of the ridge should be > 4mm. The patient should be psychologically accepting the implant and the involved procedures. The patients should have adequate oral hygiene and adequate bone quality. Exclusion Criteria: Any absolute contraindication for implant surgery such as uncontrolled diabetes mellitus, blood and/or bleeding disorders, serious osseous defects…etc. Any relevant systemic disease directly affecting bone metabolism and healing. Any habits that might reduce the blood flow and retard healing such as heavy smoking and alcoholism. A history of any grafting procedure at the designated area. Patient with thick cortical bone buccally and a thin neurovascular bundle.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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: Repositioning the bone window<br>Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window. | Procedure: Guided inferior Alveolar Nerve lateralization<br>* Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique<br>* Other names: computer guided implant placement;|
| Active Comparator: Augmentation using sticky bone<br>Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone | Procedure: Guided inferior Alveolar Nerve lateralization<br>* Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique<br>* Other names: computer guided implant placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line) | Electrophysiological test using Mental nerve Blink reflex is done for each patient before surgery(base line), after surgery at 1 month, 3 months and 6 months. | 1 month, 3 months and 6 months | 
| Clinical assessment of the change in neurosensory function recovery using Static light touch detection test. | Done at 1 week, 1 month, 3 months and 6 months postoperative. | 1 week, 1 month, 3 months and 6 months | 
| Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test. | Done at 1 week, 1 month, 3 months and 6 months postoperative. | 1 week, 1 month, 3 months and 6 months | 
| Clinical assessment of the change in neurosensory function recovery using two point discrimination test | Done at 1 week, 1 month, 3 months and 6 months postoperative. | 1 week, 1 month, 3 months and 6 months | 
| Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test. | Done at 1 week, 1 month, 3 months and 6 months postoperative. | 1 week, 1 month, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Success rate | Implant Stability using osstell device to measure the implant success at the time of implant insertion, after 3 month and at 6 month. | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inferior Alveolar nerve lateralization, neurosensory disturbance, guided surgery, Posterior atrophic mandibular ridge