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.: PACTR201307000559290 Date of Approval: 12/06/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical evaluation of the lateral approach of the maxillary sinus lifting using two different reamers with simultaneous implant placement
Official scientific title Clinical evaluation of the lateral approach of the maxillary sinus floor augmentation using two different reamers with simultaneous implant placement
Brief summary describing the background and objectives of the trial A new technique of using reamers for the lateral approach sinus floor augmentation which has insufficient information aiming to provide simplicity of bone removal , clinical applicability , time preservation and protection of sinus membrane integrity minimizing its perforation possibility. (Young kim etal. 2012)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied maxillary sinus floor augmentation,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2013
Actual trial start date 01/06/2013
Anticipated date of last follow up 01/06/2014
Actual Last follow-up date 01/06/2014
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 generated random numbers using closed envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group c reamer once 5 minutes surgical reamer 10
Control Group l s reamer once 5 minutes surgical reamer 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- upper posterior edentoulus area need sinus floor augmantation. 2- medically free patients. 3- cooperative patients and accepted to be included in the study and follow up (consent). 1-upper posterior edentoulus area less than 5mm which unsuitable for simultaneous implant placement. 2- medically compromised patients( chronic sinusitis) 18 Year(s) 90 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
Yes 07/05/2013 Ethics committee of cairo university
Ethics Committee Address
Street address City Postal code Country
al asr el ainy cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Tear of sinus membrane at surgery
Primary Outcome time of bone removal at surgery
Secondary Outcome amount of bone gaining after sinus augmentation 6 months after sinus augmentation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine cairo university al kasr el ainy st Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed mortada fikry 5 el hossary st 6 october 22344 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and dental medicine al kasr el ainy st cairo 1234 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ahmed mortada fikry 5 el hossary st 6 october 22344 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Zahran dramrzahran@gmail.com 002-01223101977 10 alnakheel st - almohandseen
City Postal code Country Position/Affiliation
giza Egypt prof of periodontology cairo university
Role Name Email Phone Street address
Principal Investigator ahmed fikry mortadafikry@hotmail.com 01223908343 5 elhossary st
City Postal code Country Position/Affiliation
6 october 22344 Egypt assistant lecturer of periodontology at misr university for science and technology
Role Name Email Phone Street address
Public Enquiries ahmed fikry mortadafikry@hotmail.com 01223908343 5 elhossary st
City Postal code Country Position/Affiliation
6 october 22344 Egypt assistant lecturer of periodontology at misr university for science and technology
Role Name Email Phone Street address
Scientific Enquiries amr zahran dramrzahran@gmail.com 002-01223101977 10 alnakheel st - almohandseen
City Postal code Country Position/Affiliation
giza 33244 Egypt prof of periodontology cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information