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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607778325580 Date of Registration: 29/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Accuracy of Different CAD Software Programs and Design Methodologies in Generating Implant-Supported Restorations
Official scientific title Accuracy of Different CAD Software Programs and Design Methodologies in Generating Implant-Supported Restorations
Brief summary describing the background and objectives of the trial Digital dental technologies have streamlined the fabrication of implant-supported restorations, yet the morphological accuracy of initial proposals generated by different computer-aided design (CAD) software algorithms remains unclear. Inaccurate initial proposals compromise clinical efficiency and can lead to inadequate restoration contours, directly impacting the precision of interproximal and occlusal contacts in the definitive prosthesis. Therefore, the purpose of this study was to evaluate and compare the 3D morphological accuracy of initial restoration proposals generated by two widely used CAD systems, exocad and Dental System 3Shape, utilizing both library and correlation design methodologies. this study aims to evaluate and compare the 3D morphological accuracy of initial restoration proposals generated by two widely used CAD systems, exocad and Dental System 3Shape, utilizing both library and correlation design methodologies.
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: Other
Anticipated trial start date 30/05/2023
Actual trial start date 31/05/2023
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date 31/03/2025
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL N/A
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 Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exocad N/A Once Exocad Software was utilized to design implant-supported restorations based on the same digital impression and design parameters. The restoration designs were exported and superimposed onto the reference STL file to evaluate morphological accuracy using the root mean square (RMS) method with 3D analysis software. 20
Control Group Dental System 3Shape N/A Once Dental System 3Shape Software was utilized to design implant-supported restorations based on the same digital impression and design parameters. The restoration designs were exported and superimposed onto the reference STL file to evaluate morphological accuracy using the root mean square (RMS) method with 3D analysis software. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Presence of adequate interarch Mesiodistal restorative space Antagonist tooth Presence of any systemic diseases Malposition dental implant Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 40 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 22/05/2025 The Ethics Committee of the Faculty of Dentisry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Root Mean Square of deviation morphological accuracy Pre treatment and immediatelly post treatment
Secondary Outcome Marginal adaptation of implant supported restoration during procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Department of Prosthodontics Faculty of Dentistry Alexandria University Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moamen Mohammed Mohsen Abdalla Sarhan Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Prosthodontics Faculty of Dentistry Alexandria University Champollion St., El Messalah, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Moataz Khamis Abdel Razek Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
Nermeen Abd Elsalam Rady Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
Moamen Mohammed Mohsen Abdalla Sarhan Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Moataz Khamis moataz_khamis@yahoo.com 00201001634254 Champollion St., El Messalah, Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Nermeen Rady nermeen.rady@alexu.edu.eg 00201223349577 Champollion St., El Messalah, Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Associate Professor of Prosthodontics Faculty of Dentistry Alexandria University Egypt
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 Moamen Sarhan moamen.sarhan@yahoo.com 00201005236943 Champollion St., El Messalah, Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Assistant Lecturer of Prosthodontics Faculty of Dentistry Alexandria University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data that will be collected during the trial, after deidentification. Informed Consent Form,Study Protocol Immediately following publication. No end date. To get the data please send an e-mail to elsayedamr@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A Yes 03/06/2026 03/06/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/06/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks N/A
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 15/07/2026 corrected 30 May 2023 31 May 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 03/06/2026 corrected 20 40
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/06/2026 yes .. because the 20 did same intervention so, they are 20 patients all did the intervention 1 and intervention 2 that is why it is not randomized trial 40 20
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 03/06/2026 corrected 20 40
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 10/06/2026 yes .. because the 20 did same intervention so, they are 20 patients all did the intervention 1 and intervention 2 40 20
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 22/07/2026 I answered this many many times they are 20 models but each of them done by the 2 scanners So they are 20 each one done by the two scanners so the total sample size is 20 (same) x 2 (scanner) = 40 20 40
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 03/06/2026 not published 03 Jun 2026
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 03/06/2026 Done as instructed N/A
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 03/06/2026 N/A N/A
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 03/06/2026 Done as instructed No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 03/06/2026 Done as instructed 41415_28585_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 10/06/2026 already uploaded 41415_28585_1045.pdf 41415_28585_1045.pdf