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.: PACTR201806003428271 Date of Approval: 30/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of New Guiding Sleeve on Intraosseous Heat Generation During Implant Site Preparation
Official scientific title Effect of New Guiding Sleeve on Intraosseous Heat Generation During Implant Site Preparation
Brief summary describing the background and objectives of the trial Osseointegration is the key factor of implant success which is strongly affected by heat generated during drilling procedure. Heating the bone up to 47c for 1 minute could be sufficient to impair bone healing and formation. Recently, using patient specific surgical guide for implant site preparation became widely accepted due to its several advantages such as, providing 3D view of bone which allows the surgeon to evaluate the bone , avoiding injury of vital structures , prosthetically driven treatment planning and flapless surgery. Despite of these advantages of guided implant surgery one of the drawbacks is heat generation as it can cause higher heat generation than conventional techniques due to friction and drill guide itself prevents the delivery of irrigation fluid. The aim of this in vitro study is to introduce and test a modified type of sleeves and to evaluate the effect of different designs of sleeves (conventional cylindrical sleeve, open (C) sleeve and modified cylindrical sleeve) and irrigation fluid temperature on intraosseous heat generated while using CAD/CAM surgical guide) during implant site preparation.
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 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
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 Open ( c- shaped) sleeves 2 minutes bovine ribs samples will be prepared and a total of 72 implant site preparations will be done through surgical guide with different types of sleeves. During drilling procedure heat generated will be measured using k-type thermocouple. 24
Experimental Group Modified cylindrical sleeves 2 minutes bovine ribs samples will be prepared and a total of 72 implant site preparations will be done through surgical guide with different types of sleeves. During drilling procedure heat generated will be measured using k-type thermocouple. 24
Control Group Conventional cylindrical sleeves 2 minutes bovine ribs samples will be prepared and a total of 72 implant site preparations will be done through surgical guide with different types of sleeves. During drilling procedure heat generated will be measured using k-type thermocouple. 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All the specimens will be taken from the same animal The samples will be cleaned and removed of all soft-tissue residues The ribs will be sawed into bone blocks of approximately 10-cm length Specimens will be all stored at -10¿C in normal saline solution between the experiments. Three hours before starting the experiment the specimens will be thawed to room temperature. for the in-vivo part of the 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 Adult: 19 Year-44 Year,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 01/05/2018 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
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
Amal Ashry Fathy 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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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information