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.: PACTR202603707948061 Date of Registration: 31/03/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of Optimal Position of Zygomatic Implants by Virtual Planning For Reconstruction of Atrophic Maxilla
Official scientific title Optimal Position Zygomatic Implants by Virtual Planning For Reconstruction of Atrophic Maxilla
Brief summary describing the background and objectives of the trial Digital technology is rapidly evolving, and recent advancements have improved precision of implants placement. Optical scans and 3D printing reduced the number of steps required from the patient's preoperative examination to the actual performance of the surgery. The aim of this study is to evaluate the efficacy of virtual planning in treatment of atrophic maxilla by optimal position of zygomatic implants. Deviation between virtually planned implants and actually placed ones were measured.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/01/2022
Actual trial start date 06/05/2023
Anticipated date of last follow up 14/04/2024
Actual Last follow-up date 14/08/2025
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
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
Single Group 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 virtual planning lifetime zygomatic implants were placed in atrophic maxilla and zygoma according to a virtually preplanned path on a software in addition to the use of static acrylic guide to determine points of entry of implant in bone 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Male or Female patient. (2) Patient more than 40 years. (3) Medical free patients. (4) patients with severely atrophic edentulous upper arch that could not be restored with other type of treatment. (1) Acute sinusitis. (2) Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma. (3) Medically compromised Patients. (4) Heavy smoker. (5) Inability to open mouyh widely. (6) interarch distance less than 22mm Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 07/06/2022 Research ethics comittee Suez canal University
Ethics Committee Address
Street address City Postal code Country
Al Sheikh Zayed, El Salam district Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Implant survival Postoperative: 1 week, 3 months, 6 months
Secondary Outcome Patient satisfaction 6 month postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez canal University El Sheikh Zayed, Al Salam district Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Agha Al Banafseg Cairo 11 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahmoud Agha Al banafseg Cairo 11 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Agha Agha.2008@live.com 01007754244 Al banafseg
City Postal code Country Position/Affiliation
Cairo 11 Egypt PhD researcher Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Amr ElSweify Prof.swify@gmail.com 01005106268 El sheikh zayed
City Postal code Country Position/Affiliation
ismailia Egypt Professor of oral and maxillofacial surgery faculty of dentistry Suez Canal University.
Role Name Email Phone Street address
Public Enquiries Ahmed Aly D.ahmed_abdelmohsen@yahoo.com 01223455289 Al salam axis
City Postal code Country Position/Affiliation
ismailia Egypt Lecturer of oral and maxillofacial surgery faculty of dentistry Suez canal university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elsholkami Mohamed_elshlkami1@deny.suez.edu.eg +201223366424 Al salam
City Postal code Country Position/Affiliation
ismailia Egypt Professor of oral and maxillofacial surgery faculty of dentistry suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data will be shared upon reasonable request Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after publication controlled access upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 24/03/2026 more accurate Optimal Position Zygomatic Implants by Virtual Planning For Reconstruction of Atrophic Maxilla Evaluation of Optimal Position of Zygomatic Implants by Virtual Planning For Reconstruction of Atrophic Maxilla
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 24/03/2026 Rephrasing and adding more information Digital technology is rapidly evolving, and recent advancements have improved precision. optical scans and 3D printing reduced the number of steps required from the patient's preoperative examination to the actual performance of the surgery. The aim of this study is to evaluate the efficacy of virtual planning in treatment of atrophic maxilla by optimal position of zygomatic implants. Digital technology is rapidly evolving, and recent advancements have improved precision of implants placement. Optical scans and 3D printing reduced the number of steps required from the patient's preoperative examination to the actual performance of the surgery. The aim of this study is to evaluate the efficacy of virtual planning in treatment of atrophic maxilla by optimal position of zygomatic implants. Deviation between virtually planned implants and actually placed ones were measured.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 24/03/2026 there was an error in the previous choice RCT Non-Randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 24/03/2026 correcting an error Sealed opaque envelopes Allocation Sequence/Code was not concealed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking type 24/03/2026 correcting an error Masking/blinding used Open-label(Masking Not Used)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 24/03/2026 one age group was missed Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 24/03/2026 the new choice is more accurate Oral Health Surgery
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/03/2026 the new description is more informative Experimental Group, virtual planning, , lifetime, zygomatic implant, 20, Experimental Group, virtual planning, , lifetime, zygomatic implants were placed in atrophic maxilla and zygoma according to a virtually preplanned path on a software in addition to the use of static acrylic guide to determine points of entry of implant in bone, 20,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 24/03/2026 more clarification Primary Outcome, Implant survival, 1 week, 3 months, 6 months Primary Outcome, Implant survival, Postoperative: 1 week, 3 months, 6 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 24/03/2026 more clarification Secondary Outcome, Patient satisfaction, 6 month Secondary Outcome, Patient satisfaction, 6 month postoperative
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 24/03/2026 Clarifying the source name Self funding, Al Banafseg, Cairo, 11, Egypt, Self Funded, Mahmoud Agha, Al Banafseg, Cairo, 11, Egypt, Self Funded,