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

Not Applicable

Completed

• Conditions: Nerve Lateralization; Posterior Atrophic Mandible; Inferior Alveolar Nerve
• Interventions: Procedure: Guided inferior Alveolar Nerve lateralization

• Registration Number: NCT04590339
• Lead Sponsor: Alexandria University

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 Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2020-12-10
• Study Completion: 2021-01-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Augmentation using sticky bone	Guided inferior Alveolar Nerve lateralization	Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone
Repositioning the bone window	Guided inferior Alveolar Nerve lateralization	Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.

Primary Outcome Measures

Name	Time	Method
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)	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.	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 Brush stroke discrimination test.	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	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.	1 week, 1 month, 3 months and 6 months	Done at 1 week, 1 month, 3 months and 6 months postoperative.

Secondary Outcome Measures

Name	Time	Method
Implant Success rate	3 months and 6 months	Implant Stability using osstell device to measure the implant success at the time of implant insertion, after 3 month and at 6 month.

Trial Locations

Locations (1)

Dina Metawie; 🇪🇬 Alexandria, Egypt