Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Repositioning the bone window
Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.
Intervention: Guided inferior Alveolar Nerve lateralization (Procedure)
Augmentation using sticky bone
Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone
Intervention: Guided inferior Alveolar Nerve lateralization (Procedure)
Outcomes
Primary Outcomes
Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.
Time Frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using two point discrimination test
Time Frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.
Time Frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)
Time Frame: 1 month, 3 months and 6 months
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.
Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.
Time Frame: 1 week, 1 month, 3 months and 6 months
Done at 1 week, 1 month, 3 months and 6 months postoperative.
Secondary Outcomes
- Implant Success rate(3 months and 6 months)