Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001497381 Date of Approval: 28/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title comparative study between inferior alveolar nerve lateralization and inferior alveolar nerve bypass as a surgical method for implant insertion
Official scientific title Evaluation of Neurosensory Deficits following the Use of Computer Assisted Surgical Guide for Inferior Alveolar Nerve Bypass versus Inferior Alveolar Nerve Lateralization
Brief summary describing the background and objectives of the trial Rehabilitation of resorbed posterior mandible was carried out by many surgical tech.1.ridge splitting 2.ridge augmentation 3.nerve relocation which considered a major surgery with many complications.A cone beam computed tomography has been proven to be a good imaging system in order to bypass inferior alveolar nerve. The aim of the study is to evaluate the neurosensory deficits of the inferior alveolar nerve following inferior alveolar nerve lateralization versus inferior alveolar nerve bypass.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Nl nerve lateralizat
Disease(s) or condition(s) being studied Nervous System Diseases,Oral Health,resorbed posterior mandible,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 30/01/2017
Actual trial start date 07/02/2017
Anticipated date of last follow up 30/01/2019
Actual Last follow-up date 07/02/2019
Anticipated target sample size (number of participants) 26
Actual target sample size (number of participants) 20
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
311 622
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised using computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group inferior alveolar nerve lateralization unilateral procedure period of follow up(2 years) implant placement following the inferior alveolar nerve lateralization 10 Active-Treatment of Control Group
Experimental Group inferior alveolar nerve bypass unilateral procedure period of follow up(2 years) implant placement following the inferior alveolar nerve bypass 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.partialy edentulous ridge . 2.patient signing informed consent 3.patient age range from 20to 80 years 1.heavy smoker patient. 2.previous mandibular fracture 3.any contraindicating systemic disease 20 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 05/06/2016 oral and dental ethic committe-cairo university
Ethics Committee Address
Street address City Postal code Country
el manil street cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neurosensory deficits 1.static light touch detection (seconds) 2.Brush stroke discrimination (seconds) 3.Two point discrimination (mm)
Secondary Outcome implant angulation Cone beam computed tomography ( CBCT ) _ Angle degree
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El qassr el eani el manil street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ibrahim (main investigator) 11 hosny metwaly street giza Egypt
Ahmed Ibrahim (main investigator) 11 hosny metwaly street arezona el haram giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Ibrahim (main investigator) 11 hosny metwaly street arezona el haram giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr.Hisham abd el hakm 9 street cairo .el maadi Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ebrahim dentist.ahmed78@yahoo.com 01222936434 1 1 hosny metwally el arezona el haram
City Postal code Country Position/Affiliation
Giza Egypt Egypt
Role Name Email Phone Street address
Public Enquiries Basma mohamed dentist.ahmed78@yahoo.com 01283147176 11 hosny metwaly el arezona el haram
City Postal code Country Position/Affiliation
giza Egypt egypt
Role Name Email Phone Street address
Scientific Enquiries Hisham Abd AL hakam dentist.ahmed78@yahoo.com 01156096060 9street el maadi . number 70
City Postal code Country Position/Affiliation
cairo Egypt egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information