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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: www.pactr.org

Trial no.: PACTR201307000559290 Date registered: 2013/06/12
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
Purpose of the trial Treatment
Anticipated trial start date 2013-06-01
Actual trial start date 2013-06-01
Anticipated date of last follow up 2014-06-01
Actual date of last follow up 2014-06-01
Anticipated target sample size (number of participants) 20   
Actual target sample size (number of participants) 20   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group l s reamer once 5 minutes surgical reamer 10 Active
Experimental group c reamer once 5 minutes surgical reamer 10

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 90 Years 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 2013/05/07 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 Fax
Principal Investigator Prof Amr Zahran dramrzahran@gmail.com 002-01223101977
Street address City Postal code Country Position / Affiliation
10 alnakheel st - almohandseen giza Egypt prof of periodontology cairo university
Role Name Email Phone Fax
Principal Investigator Dr ahmed fikry mortadafikry@hotmail.com 01223908343 38377807
Street address City Postal code Country Position / Affiliation
5 elhossary st 6 october 22344 Egypt assistant lecturer of periodontology at misr university for science and technology
Role Name Email Phone Fax
Public Enquiries Dr ahmed fikry mortadafikry@hotmail.com 01223908343 38377807
Street address City Postal code Country Position / Affiliation
5 elhossary st 6 october 22344 Egypt assistant lecturer of periodontology at misr university for science and technology
Role Name Email Phone Fax
Scientific Enquiries Prof amr zahran dramrzahran@gmail.com 002-01223101977 002-01223101977
Street address City Postal code Country Position / Affiliation
10 alnakheel st - almohandseen giza 33244 Egypt prof of periodontology cairo university