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

Inferior Alveolar Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590339
• Other study ID #: 0010556-IORG 00088390
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: January 10, 2021

Study information

• Verified date: July 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 10, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Inferior Alveolar Nerve
• Nerve Lateralization
• Posterior Atrophic Mandible

Intervention

Procedure:
• Guided inferior Alveolar Nerve lateralization
Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique

Locations

Country	Name	City	State
Egypt	Dina Metawie	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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