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

NCT ID: NCT06961045

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2026-12-31

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. Will the postoperative neurosensory disturbances after the surgical intervention fade out and if not, will it be annoying to the patient?

2. Can we consider inferior alveolar nerve lateralization efficient substitute to short implants?

3. will the inserted implants going to be properly ossteointegrated at the site of osteotomy for lateralization?

Conditions

Neurosensory Function of Inferior Alveolar Nerve

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main single arm for the clinical trial

Group Type: OTHER

Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement

Intervention Type: 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.

Interventions

Guided Inferior Alveolar Nerve Lateralization with Simultaneous Implant Placement

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AYMAN M. ARAKEEP, MSc, PhD researcher

OTHER

Sponsor Role: lead

Responsible Party

AYMAN M. ARAKEEP, MSc, PhD researcher

Assistant Lecturer of Oral and Maxillofacial surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

OS 4-24 2184

Identifier Type: -

Identifier Source: org_study_id