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.: PACTR201907800151481 Date of Approval: 22/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Accuracy of Implants Placed Using Fully Versus Partially Guided Tissue Supported 3D Printed Surgical Guides
Official scientific title Accuracy of Implants Placed Using Fully Versus Partially Guided Tissue Supported 3d Printed Surgical Guides
Brief summary describing the background and objectives of the trial With the advancement of implant imaging and computer technology, surgeons can transfer the preoperative plan to the surgical process. Therefore, a surgical guide based on cone-beam computer tomography (CBCT) gains more importance in dental implantology which not only shortens the operative time but also minimizes invasiveness. Implant insertion can be performed through surgical guide sleeve defined as fully guided surgery or freehanded without guidance through a sleeve, mainly defined as partially-guided surgery. However, the accuracy of both insertion modalities has not been compared till now and the benefit in terms of higher accuracy for flapless surgery has not been proven for fully guided systems. Additionally, the control over implant direction is usually achieved with a closed circular configuration with small drill tolerance. This is always associated with accessibility problems in the posterior region and thought to block the passage of the irrigation. Surgical guide designed with a c-shaped guiding hole with a facial opening allows for side approach of the drills and unrestricted access of the coolant. But further investigations are required to evaluate its accuracy and long term success rates. The aim of this in-vivo study is to evaluate the accuracy of implant placement using fully guided versus partially guided surgical guides with cylindrical versus c-shaped guiding holes.
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 01/08/2019
Actual trial start date 01/08/2019
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/08/2020
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
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 randomization 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 Surgical guide Dental Implants fully guided protocol cylindrical guide hole At application and then for life unless failure Tissue supported surgical guides will be constructed utilizing 3D printing technology, each guide consist of a cylindrical guide hole with fully guided protocol 12
Experimental Group Surgical guide Dental Implants fully guided protocol C shape guide hole At application and then for life unless failure Tissue supported surgical guides will be constructed utilizing 3D printing technology, each guide consist of c-shape guide hole with fully guided protocol 12
Control Group surgical guide Dental Implants partially guided protocol cylindrical guide hole At application and then for life unless failure Tissue supported surgical guides will be constructed utilizing 3D printing technology, each guide consist of cylindrical guide hole with partially guided protocol 12 Active-Treatment of Control Group
Control Group surgical guide Dental Implants partially guided protocol C shape guide hole At application and then for life unless failure Tissue supported surgical guides will be constructed utilizing 3D printing technology, each guide consist of c-shape guide hole with partially guided protocol 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Completely edentulous patients with skeletal Class I maxilla-mandibular relationship. Adequate inter-arch space (22 mm), (by using the "try in" as a measure before any intervention taking place). Maxillary and mandibular ridges with no history of recent extraction. Mandibular ridge should be ≥15 mm height and ≥ 6 mm width to house four implants in the intra-foramina area of mandibular arch this will be verified by using cone-beam computed tomography (CBCT). History of radiotherapy in the head and neck region. History of hard tissue augmentation. Presence of any intra-oral pathological condition. Any medical disorder that could complicate the surgical phase or affect osseointegration as osteoporosis, uncontrolled diabetes, and hypertension. Heavy smokers (more than 20 cigarettes/ day). 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 01/12/2017 IRB Faculty of Denistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champlion Street Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Linear deviations of the implant hex immediately after surgery
Primary Outcome Linear deviations of the implant apex immediately after surgery
Primary Outcome The angular deviations of the implant axis immediately after surgery
Secondary Outcome Implant height/depth immediately after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Prosthodontics Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moamen Mohammed Mohsen Abdalla Sarhan 398 hooria street moustafa kamel Alexandria 21529 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Prosthodontics Dentistry Faculty of Dentistry Alexandria University Champilon street, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahlam EL Sharkawy 19 Zaki Ragab ST., City Stars Tower , Smouha Alexandria 21615 Egypt
Mohamed Moataz Khamis 20, Amin Fekry St., mehatet el raml Alexandria 21563 Egypt
Moamen Mohammed Mohsen Abdalla Sarhan 398 hooria street moustafa kamel Alexandria 21529 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahlam El sharkawy drahlamsharkawy@yahoo.com 00201224005900 19 Zaki Ragab ST., City Stars Tower , Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Moataz Khamis Moataz_khamis@yahoo.com 00201001634254 20 Amin Fekry Street mehatet el raml
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University
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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information