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.: PACTR201603001536183 Date of Approval: 16/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical and Radiographic evaluation of short implants (5.5mm) and standard implants (10MM) with internal sinus floor elevation in posterior maxilla
Official scientific title Clinical and Radiographic evaluation of short implants (5.5mm) and standard implants (10MM) with internal sinus floor elevation in posterior maxilla
Brief summary describing the background and objectives of the trial Clinical and Radiographic evaluation of short implants (5.5mm) and standard implants (10MM) with ostetome sinus floor elevation in posterior maxilla
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 23/03/2016
Actual trial start date
Anticipated date of last follow up 01/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 patients will be randomly selected using computer generated randomization and will be performed by another individual other than the investigator . the numbers will be allocated to each patients the two groups will be equally prepared for surgical implant placement . then the decision of which implant length to use will be selected according to the randomized numbers in the envelope . the number will be picked by a person other than the operator Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard length implant with osteotome sinus floor elevation 27 Active-Treatment of Control Group
Experimental Group short implants placed in posterior maxilla short implants placed in posterior maxilla 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-partially edentulous patients in the maillary posterior region 2-medically free patients 3-presence of proper inter-arch space for placement of the implant prothetic part 4-adequate soft tissue biotype (>2mm) 5-the available bone geight below the maxillary sinus should be 7mm +/-1 6-non-smoker 7-patients >20 years old 8-good oral hygiene 9- accepts one year follow-up period 10- patients provides an informed consent 1-patients with systemic conditions that may interfere with the results of the study 2-patients with local pathological defects related to the area of interest 3- unmotivated , uncooperative patients with poor oral hygiene 4-patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking , alcoholism or parafunctional habits 5-inadequate inter-arch space for implant prosthetic part 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
Yes ethical committee of cairo university
Ethics Committee Address
Street address City Postal code Country
11 saraia streat el manial cairo 11559 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome primary implant stability Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
Secondary Outcome crestal bone resorption day of surgery 3 month after surgery 6 month after surgery
Secondary Outcome Post operative pain 12 days after surgery
Secondary Outcome post operative swelling 8 days after surgery
Secondary Outcome probing depth Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
Secondary Outcome gingival recesion Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
Secondary Outcome modified plaque index Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
Secondary Outcome modified gingival index Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
Secondary Outcome modified bleeding on probing index Day of surgery 3 month after surgery 6 month after surgery 9 month after surgery 12 month after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university - department of periodontology 11 saraya street , el manial giza 11559 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 11 saraya street , el manial cairo 11559 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mostafa magdy awad 15 hanadi streat - el haram- iza giza 11559 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mostafa magdy awad 15 el hanadi street - el haram giza 12557 Egypt
sobhy alloush 6 of october 6 of october 12566 Egypt
menna tállah farid sheraton cairo 11799 Egypt
hany el nahass dokki giza 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hany El Nahass nahass77@gmail.com 01002659854 dokki
City Postal code Country Position/Affiliation
giza 12611 Egypt cairo university , faculty of dentistry
Role Name Email Phone Street address
Public Enquiries mostafa magdy mostafa_magdy@hotmail.com 01000356793 el haram
City Postal code Country Position/Affiliation
giza 12557 Egypt cairo university , faculty of dentistry
Role Name Email Phone Street address
Scientific Enquiries hany El Nahass nahass77@gmail.com 01002659854 dokki
City Postal code Country Position/Affiliation
giza 12611 Egypt cairo university , faculty of dentistry
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information