NCT04590339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

August 12, 2020

Last Update Submit

July 27, 2021

Conditions

Posterior Atrophic MandibleInferior Alveolar NerveNerve Lateralization

Keywords

inferior Alveolar nerve lateralizationneurosensory disturbanceguided surgeryPosterior atrophic mandibular ridge

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    1 week, 1 month, 3 months and 6 months

  • 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.

    1 week, 1 month, 3 months and 6 months

  • 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.

    1 week, 1 month, 3 months and 6 months

  • 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.

    1 week, 1 month, 3 months and 6 months

Secondary Outcomes (1)

  • Implant Success rate

    3 months and 6 months

Study Arms (2)

Repositioning the bone window

ACTIVE COMPARATOR

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

Procedure: Guided inferior Alveolar Nerve lateralization

Augmentation using sticky bone

ACTIVE COMPARATOR

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

Procedure: Guided inferior Alveolar Nerve lateralization

Interventions

Guided inferior Alveolar Nerve lateralizationPROCEDURE

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

Also known as: computer guided implant placement
Augmentation using sticky boneRepositioning the bone window

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dina Metawie

Alexandria, 21500, Egypt

Location

Study Officials

  • Dina N. Metawie

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

October 19, 2020

Study Start

October 25, 2018

Primary Completion

December 10, 2020

Study Completion

January 10, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)