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Enrolling by Invitation

NCT Number: NCT06961045

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

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?

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Key information

Conditions

Neurosensory Function of Inferior Alveolar Nerve

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. clinical neurosensory testing of the inferior alveolar nerve function

    Time frame: Postoperatively 1 week, 1 month, 3 months, 6 months

    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.

Sponsors and collaborators

Lead sponsor

AYMAN M. ARAKEEP, MSc, PhD researcher

Other

Registry information

Official study title

Computer - Guided Inferior Alveolar Nerve Lateralization With Simultaneous Prosthetic Driven Implant Placement

Acronym: IANL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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