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Completed

NCT Number: NCT04590339

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

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.

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Key information

Conditions

Posterior Atrophic Mandible Inferior Alveolar Nerve Nerve Lateralization

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dina Metawie

Alexandria, 21500, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Guided inferior Alveolar Nerve lateralization

Procedure

Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique

Other names: computer guided implant placement

Primary outcomes

  1. Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)

    Time frame: 1 month, 3 months and 6 months

    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.

  2. Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.

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

    Done at 1 week, 1 month, 3 months and 6 months postoperative.

  3. Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.

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

    Done at 1 week, 1 month, 3 months and 6 months postoperative.

  4. Clinical assessment of the change in neurosensory function recovery using two point discrimination test

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

    Done at 1 week, 1 month, 3 months and 6 months postoperative.

  5. Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.

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

    Done at 1 week, 1 month, 3 months and 6 months postoperative.

Secondary outcomes

  1. Implant Success rate

    Time frame: 3 months and 6 months

    Implant Stability using osstell device to measure the implant success at the time of implant insertion, after 3 month and at 6 month.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jul 28, 2021

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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