Clinical trial NCT04590339: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Atrophic Mandible
Inferior Alveolar Nerve
Nerve Lateralization
Keywords: inferior Alveolar nerve lateralization
neurosensory disturbance
guided surgery
Posterior atrophic mandibular ridge
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in neurosensory recovery and sensation regaining over 6 months compared to normal (taken at base line)
timeFrame: 1 month, 3 months and 6 months
measure: Clinical assessment of the change in neurosensory function recovery using Static light touch detection test.
timeFrame: 1 week, 1 month, 3 months and 6 months
measure: Clinical assessment of the change in neurosensory function recovery using Brush stroke discrimination test.
timeFrame: 1 week, 1 month, 3 months and 6 months
measure: Clinical assessment of the change in neurosensory function recovery using two point discrimination test
timeFrame: 1 week, 1 month, 3 months and 6 months
measure: Clinical assessment of the change in neurosensory function recovery using pin-prick sensation test.
timeFrame: 1 week, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Implant Success rate
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Dina Metawie
Study officials:
affiliation: Alexandria University
name: Dina N. Metawie
role: PRINCIPAL_INVESTIGATOR
References: