Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement in Atrophic Posterior Mandible

July 3, 2025 updated by: Muhammad Ashraf Elsawi, Cairo University

Evaluation of Neurosensory Function of Inferior Alveolar Nerve Following Lateralization With Sticky Bone Versus Nil Using Computer Guided Dental Implant Placement: A Randomized Clinical Trial

The aim of this study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main disadvantage of this technique & provide a reliable,saving time - computer guided simultaneous implant placement- and improved technique.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lateralization of IAN allows simultaneous implant placement with longer implants and primary stability.2 IAN lateralization provides an option to avoid costly, prolonged bone graftt and also healing periods can be reduced by this option of treatment Vestibular depth remains intact as there is no augmentation in the underlying bone defect. 2 IAN lateralization technique has also some advantages such as less morbidity and less of peri-implant disease.2 In case of the IAN is located in the superior part of the body of the mandible , and presence of mild atrophy of the edentulous alveolar ridge will fetch the alveolar ridge in a close relation to the neuro-vascular bundle, The incidence of "high" IAN locations ranges from 14.6 to 30.7%. 1However there is some complications such as numbness after surgery which is considered as the most common one also prevent thermal conductivity via implants(Kahnberg et al., 2000) so sticky bone is going to be used to act as an insulator between dental imlants & Inferior alveolar nerve and it contains a number of growth factors so it is predicted to play an important role to enhance recovery of the inferior alveolar nerve after surgery

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients requiring oral rehabilitation with dental implants in vertically atrophied

    • Posterior mandibular region, less than 8mm of bone above the mandibular canal.
    • Patients should be free from any systemic conditions that may affect normal healing.
    • Absence of any pathological conditions involving mandibular bones.

Exclusion Criteria:

  • Patients under bisphosphonates treatment.

    • Any contraindication for general anaesthesia.
    • Osteoporotic patients.
    • Patients with neurological disorders (neuralgias, Parkinson' s disease).
    • Patients with systematic disease that may complicate healing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Computer guided immediate implant placement & IAN lateralization
Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.
Procedure: Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization only.
Standard procedure without Sticky Bone application.
Experimental: computer guided immediate implant placement & IAN lateralization with Sticky bone
Patients receiving computer-guided immediate implant placement and inferior alveolar nerve (IAN) lateralization with sticky bone
Procedure: IAN lateralization with computer-guided immediate implant placement using Sticky Bone
The same as the control with additional application of Sticky Bone as an insulator for enhanced neurosensory disfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical neurosensory assessment of inferior alveolar nerve.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IAN Lateralization

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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