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
Sponsored by
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
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
No
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