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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04590339
Enrollment
20
Registered
2020-10-19
Start date
2018-10-25
Completion date
2021-01-10
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inferior Alveolar Nerve, Nerve Lateralization, Posterior Atrophic Mandible

Keywords

inferior Alveolar nerve lateralization, neurosensory disturbance, guided surgery, Posterior atrophic mandibular ridge

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREGuided inferior Alveolar Nerve lateralization

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)1 month, 3 months and 6 monthsElectrophysiological 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.
Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.1 week, 1 month, 3 months and 6 monthsDone at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.1 week, 1 month, 3 months and 6 monthsDone at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using two point discrimination test1 week, 1 month, 3 months and 6 monthsDone at 1 week, 1 month, 3 months and 6 months postoperative.
Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.1 week, 1 month, 3 months and 6 monthsDone at 1 week, 1 month, 3 months and 6 months postoperative.

Secondary

MeasureTime frameDescription
Implant Success rate3 months and 6 monthsImplant Stability using osstell device to measure the implant success at the time of implant insertion, after 3 month and at 6 month.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026