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Assessment of the Neurosensory Alteration After Inferior Alveolar Nerve Lateralization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669510
Recruitment Status : Unknown
Verified September 2018 by Mohamed Reda Mohamed Abdelhady, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Reda Mohamed Abdelhady, Cairo University

Brief Summary:
: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement

Condition or disease Intervention/treatment Phase
Implant Site Reaction Other: computer guided IAN lateralization surgical technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: atrophic posterior mandible requiring nerve lateralization
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Neurosensory Alteration With Computer Guided Inferior Alveolar Nerve Lateralization Versus Non Guided Classic Technique
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: computer gaiuded IAN
Computer guided surgical technique
Other: computer guided IAN lateralization surgical technique
Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique

Experimental: Classical technique
Non computer guided surgical technique
Other: computer guided IAN lateralization surgical technique
Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique




Primary Outcome Measures :
  1. Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10) [ Time Frame: 2 months up to 1 year ]
    assessing the sensation regaining over time subjective (a scale 1-10 )


Secondary Outcome Measures :
  1. Implant stability [ Time Frame: At the placement and after exposure ( up to 6 months ) ]
    Measurements of the implant stability immediately after placement by osstell



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients with with atrophied posterior mandibular ridge
  • both sexes
  • NO intra oral soft and hard tissue pathology
  • NO systematic that contraindicate implant placement

Exclusion Criteria:

  • Presence pathological lesion
  • Heavy smokers more than 20 cigarettes per day.
  • patients with systemic disease that may affect normal healing
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Responsible Party: Mohamed Reda Mohamed Abdelhady, director, Cairo University
ClinicalTrials.gov Identifier: NCT03669510    
Other Study ID Numbers: 14422016552019
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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