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.: PACTR201806003429357 Date of Approval: 30/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Heat Generation During Implant Placement in High-density Bone: Effect of Different Drilling Techniques
Official scientific title Heat Generation During Implant Placement In High-density Bone: Effect of Different Drilling Techniques
Brief summary describing the background and objectives of the trial Successful implant therapy depends mainly upon osseointegration,which necessitates preservation of the vitality of the bone cells. However, thermal damage to the bone cells during drilling and implant placement have become a great challenge especially for those of highly calcified bone type. Excessive heat inducesbone cells necrosis which threatens the hydroxyapatite mineral lattice structure which results in loss of osseointegration and early failure of implant therapy. The aim of the study is to measure the effect of different surgical techniques on the least heat generation possible, particularly in the thick layer of compact bone without jeopardizing, the primary stability of the dental implants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental Implants patients,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/07/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 01/07/2019
Actual Last follow-up date 01/07/2019
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
Recruitment status Not yet 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 Permuted block randomi sation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Undersized drilling [UD] bovine ribs samples will be prepared and a total of 24 implant site preparations besides 3 holes for each thermocouple insertion per each implant site will be done through surgical guide . During implant insertion procedure heat generated will be measured using k-type thermocouple and the insertion torque value will be will be recorded onto a PC connected to the implant engine. 8
Experimental Group Undersized drilling + Cortical drill [UD+CD] bovine ribs samples will be prepared and a total of 24 implant site preparations besides 3 holes for each thermocouple insertion per each implant site will be done through surgical guide . During implant insertion procedure heat generated will be measured using k-type thermocouple and the insertion torque value will be will be recorded onto a PC connected to the implant engine. 8
Experimental Group Undersized drilling + Cortical tap[UD+CT] bovine ribs samples will be prepared and a total of 24 implant site preparations besides 3 holes for each thermocouple insertion per each implant site will be done through surgical guide . During implant insertion procedure heat generated will be measured using k-type thermocouple and the insertion torque value will be will be recorded onto a PC connected to the implant engine. 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-All the specimens will be taken from the same animal 2-The samples will be cleaned and removed of all soft-tissue residues 3- The ribs will be sawed into bone blocks of approximately 10-cm length 4- Specimens will be all stored at -10¿C in normal saline solution between the experiments. 5- Three hours before starting the experiment the specimens will be thawed to room temperature. for the in-vivo study: Patient free from diabetes . Patient free from osteoporosis . Patient free from previous radiotherapy. 1-The specimens which are not from the same animal 2-The samples with remaining soft-tissue residues 3- The ribs will be sawed into bone blocks of wrong length. 4- Broken specimens during preparation. 5- Specimens not properly stored. temperature(34). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 15/05/2018 IRB: Faculty of Dentistry, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Temperature measured in degree centigrade's All through the study
Primary Outcome Insertion torque value measured in Nm During implant insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of removable prosthodontics ¿ Faculty of Dentistry- Alexandria university 17 Champollion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Dentistry, Alexandria University. 17 Champollion St., Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry, Alexandria University. 17 Champollion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Sherine El Attar 17 Champollion St., Azarita Alexandria 21521 Egypt
Osama Ahmed Ali El-Samni 17 Champollion St., Azarita Alexandria 21521 Egypt
Mostafa Ahmed Aboulfath 17 Champollion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Sherine El-Attar president@aoiaegypt.com 002-01222140037 17 Champolion St. Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Removable Prosthodonticand Chairman of Alexandria Oral Implantology Association
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Osama El- Samni elsamni@gmail.com 002- 01008382338 17 Champolion St. Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor and Head of Thermal Division- department of mechanics
REPORTING
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Changes to trial information