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

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

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.

Study Overview

• Status: Completed
• Conditions: Posterior Atrophic Mandible; Inferior Alveolar Nerve; Nerve Lateralization
• Intervention / Treatment: Procedure: Guided inferior Alveolar Nerve lateralization

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21500
    • Dina Metawie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Repositioning the bone window; Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.	Procedure: Guided inferior Alveolar Nerve lateralization; Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique; Other Names: computer guided implant placement
Active Comparator: Augmentation using sticky bone; Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone	Procedure: Guided inferior Alveolar Nerve lateralization; Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique; Other Names: computer guided implant placement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Dina N. Metawie, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): January 10, 2021

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: inferior Alveolar nerve lateralization; neurosensory disturbance; guided surgery; Posterior atrophic mandibular ridge
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 0010556-IORG 00088390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No