Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement Will be Performed on 10 Surgical Sides (Mandibular Quadrants) to Evaluate the Postoperative Neurosensory Disturbances Following Guided Inferior Alveolar Nerve Lateralization

NCT06961045 | Enrolling By Invitation DMC

• 1 other identifier: OS 4-24 2184
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to primarily evaluate the postoperative neurosensory disturbances following guided inferior alveolar nerve lateralization with simultaneous implant placement in 10 surgical sides (mandibular quadrants distal to the mental foramen) either in males or females with age range from 30 to 75 years. The main questions it aims to answer are:

1. 1.Will the postoperative neurosensory disturbances after the surgical intervention fade out and if not, will it be annoying to the patient?
2. 2.Can we consider inferior alveolar nerve lateralization efficient substitute to short implants?
3. 3.will the inserted implants going to be properly ossteointegrated at the site of osteotomy for lateralization?

Conditions

Neurosensory Function of Inferior Alveolar Nerve

Keywords

Inferior Alveolar Nerve Lateraliztion; Computer Assisted; Clinical neurosensory Testing

Outcome Measures

Primary Outcomes (1)

• clinical neurosensory testing of the inferior alveolar nerve function

  We will use the light touch test and sensitivity mapping by applying moderated pressure with a periodontal probe to depress the skin by 1-2 mm while the patients will be seated comfortably in a quiet room with their eyes closed throughout the procedures. We will show the hypo aesthetic area as a graphic to illustrate its extension. We will choose this technique because it selects the dysfunction of rapidly adapting long myelinated fibers, which are 90% of the fibers of the IAN.

  Postoperatively 1 week, 1 month, 3 months, 6 months

Study Arms (1)

Main single arm for the clinical trial

OTHER

Procedure: Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement

Interventions

Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement PROCEDURE

All patients will be operated on under general anesthesia. A para-crestal incision will be done and a mucoperiosteal flap will be reflected exposing the alveolar ridge and the buccal cortex. The surgical guide will be fitted and fixed in place and the outline of the window will be drawn by the aid of the surgical guide using the piezotome then the guide will be removed. Once the osteotomy is completed the bone window will be mobilized for exposure of the neurovascular bundle. The diamond tips will be used for removal of any remaining bone around the nerve. The neurovascular bundle will be dissected and retracted properly. a surgical guide will be inserted for implant osteotomy. The bone block which was removed for the buccal window will be crushed to be particulates and will be mixed with autologous fibrin glue for preparation of sticky bone, the sticky bone will be packed gently in the window area around the neurovascular bundle then will be covered by platelet rich fibrin.

Main single arm for the clinical trial

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrophic mandibular ridges distal to the mental foramen with residual alveolar bone height ≤ 8 mm above the IAN.
• The width of the alveolar ridge ≥ 6 mm, 3mm down from the alveolar crest.

You may not qualify if:

• All patients suffering from any systemic disease that may contraindicate implant surgery or affect bone healing and osseointegration of implant.
• Previous history of bone augmentation or implant placement in the site planned for nerve lateralization.

Sponsors & Collaborators

• AYMAN M. ARAKEEP, MSc, PhD researcher: lead

Study Sites (1)

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Oral and Maxillofacial surgery

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: February 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)