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

• ClinicalTrials.gov Identifier: NCT04590339
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: July 28, 2021
• Sponsor: Alexandria University
• Information provided by (Responsible Party): Alexandria University

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.

Condition or disease	Intervention/treatment	Phase
Posterior Atrophic Mandible; Inferior Alveolar Nerve; Nerve Lateralization	Procedure: Guided inferior Alveolar Nerve lateralization	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation: A Randomized Controlled Clinical Trial
• Actual Study Start Date: October 25, 2018
• Actual Primary Completion Date: December 10, 2020
• Actual Study Completion Date: January 10, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Repositioning the bone window; Computer guided inferior alveolar nerve lateralization and implant placement with subsequent repositioning of the osteotomized bone window.	Procedure: Guided inferior Alveolar Nerve lateralization; Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique; Other Name: computer guided implant placement
Active Comparator: Augmentation using sticky bone; Computer guided inferior alveolar nerve lateralization and implant placement with grafting around the implant using sticky bone	Procedure: Guided inferior Alveolar Nerve lateralization; Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique; Other Name: computer guided implant placement

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Dina Metawie

Alexandria, Egypt, 21500

Sponsors and Collaborators

Alexandria University

Investigators

• Principal Investigator: Dina N. Metawie; Alexandria University

More Information

• Responsible Party: Alexandria University
• ClinicalTrials.gov Identifier: NCT04590339
• Other Study ID Numbers: 0010556-IORG 00088390
• First Posted: October 19, 2020
• Last Update Posted: July 28, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandria University:

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

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical