Back to results

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

Primary Purpose

Posterior Atrophic Mandible, Inferior Alveolar Nerve, Nerve Lateralization

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Guided inferior Alveolar Nerve lateralization

About this trial

This is an interventional treatment trial for Posterior Atrophic Mandible focused on measuring inferior Alveolar nerve lateralization, neurosensory disturbance, guided surgery, Posterior atrophic mandibular ridge

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Dina Metawie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Repositioning the bone window

Augmentation using sticky bone

Arm Description

Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.

Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone

Outcomes

Primary Outcome Measures

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

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.

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

Done 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.

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

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

Done 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.

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

Secondary Outcome Measures

Implant Success rate

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

Full Information

NCT ID

NCT04590339

First Posted

August 12, 2020

Last Updated

July 27, 2021

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04590339

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

December 10, 2020 (Actual)

Study Completion Date

January 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posterior Atrophic Mandible, Inferior Alveolar Nerve, Nerve Lateralization

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Repositioning the bone window

Arm Type

Active Comparator

Arm Description

Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.

Arm Title

Augmentation using sticky bone

Arm Type

Active Comparator

Arm Description

Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone

Intervention Type

Procedure

Intervention Name(s)

Guided inferior Alveolar Nerve lateralization

Other Intervention Name(s)

computer guided implant placement

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1 month, 3 months and 6 months

Title

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

Description

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

Time Frame

1 week, 1 month, 3 months and 6 months

Title

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

Description

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

Time Frame

1 week, 1 month, 3 months and 6 months

Title

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

Description

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

Time Frame

1 week, 1 month, 3 months and 6 months

Title

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

Description

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

Time Frame

1 week, 1 month, 3 months and 6 months

Secondary Outcome Measure Information:

Title

Implant Success rate

Description

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

Time Frame

3 months and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina N. Metawie

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dina Metawie

City

Alexandria

ZIP/Postal Code

21500

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs