Scan Time and Prosthetic Complications of Intraoral Scanning Versus Intraoral Photogrammetry for Full-Arch Titanium Framework With Zirconia Overlay Implant Screw-Retained Prostheses: A Randomized Clinical Trial
Phase: NA
Conditions: Scan Time
Sponsor: Cairo University

 
+ 
 
Scan Time and Prosthetic Complications of Intraoral Scanning 
Versus Intraoral Photogrammetry for Full-Arch Titanium 
Framework with Zirconia Overlay Implant Screw-Retained 
Prostheses: A Randomized Clinical Trial 
 
 
 
 
 
Submitted for partial fulfillment of the Ph D requirements in Faculty of 
Dentistry 
Cairo University 
 
By 
Nour El Hoda Mahmoud Naguib El Tarabishi 
B.D.S. Cairo University (2017)  
M.Sc. Cairo University (2023)  
PROSR 6-2-1 
11-2-2025 
 
Supervisors’ signature 
Head of department’s signature 
1- 
 
 
2- 
 
 
Date 
 
 
 
 
 
 
 
 
 

 
Protocol checklist 
Section and topic 
Item no. 
Checked item 
Reported 
on page No. 
Reviewer’s 
check 
I. Administrative information 
1 
Title 
1 
 
2 
Protocol registration 
1 
 
3 
Protocol version 
1 
 
4 
Funding 
1 
 
5 
Roles and responsibilities 
1 
 
 
II. Introduction 
 
 
 
A) Background and Rationale 
6 a 
Research question  
3 
 
Statement of the problem 
3 
 
Rationale for carrying out the 
trial 
3 
 
Review of literature 
3 
 
6 b 
Choice of comparators 
4 
 
B) Objectives 
7 
Aim of the study 
5 
 
Hypothesis 
5 
 
Primary and secondary objectives 
5 
 
C) Trial design 
8 
Trial design 
5 
 
 
III. Methods 
 
 
 
A) Participants, interventions 
& outcomes 
9 
Study setting 
5 
 
10 
Eligibility criteria 
6 
 
11 
Interventions 
6 
 
12 
Outcomes 
8 
 
13 
Participant timeline 
9 
 
14 
Sample size 
10 
 
15 
Recruitment 
10 
 
B) Assignment of 
interventions 
16 
Allocation 
10 
 
16 a 
Random sequence generation 
(Randomization) 
10 
 
16 b 
Allocation concealment 
mechanism 
10 
 
16 c 
Implementation 
10 
 
17 
Blinding (masking) 
10 
 
C) Data collection, 
management, and analysis 
18 
Data collection methods 
10 
 
19 
Data management 
11 
 
20 
Statistical methods 
11 
 
D) Monitoring 
21 
Data monitoring 
11 
 
22 
Harms 
11 
 
23 
Auditing 
11 
 
 
IV. Ethics and dissemination 
24 
Research ethics approval 
12 
 
25 
Protocol amendments 
12 
 

 
26 
Informed Consent  
12 
 
27 
Confidentiality 
12 
 
28 
Declaration of interests 
12 
 
29 
Access to data 
12 
 
30 
Ancillary and post-trial care 
12 
 
31 
Dissemination policy 
12 
 
 
V. Appendices 
 
32 
Informed consent materials 
13 
 
 
33 
Biological specimens 
14 
 
 
VI. References 
 
 
 
15 
 
 
Evidence based committee (Reviewers) 
 
Name 
Signature 
Date 
1. 
 
 
 
2. 
 
 
 
 
Research plan committee 
 
Name 
Signature 
Date 
1.  
 
 
 
2.  
 
 
 

1 
 
 
Administrative information: 
1. Title:  
Scan Time and Prosthetic Complications of Intraoral Scanning Versus Intraoral Photogrammetry for Full-Arch 
Titanium Framework with Zirconia Overlay Implant Screw-Retained Prostheses: A Randomized Clinical Trial 
 
2. Protocol Registration:  
The study will be registered on clinicaltrials.gov. 
 
3. Protocol version:  
This is the first version of the protocol. 11th February 2025 Protocol number: 1.    
 
4. Funding:  
Self-funding. 
 
5. Roles and responsibilities: 
1. Prof. Amr Hosny Mostafa El Khadem (AK) 
− Professor of Prosthodontics, Faculty of Dentistry, Cairo University. 
− Main supervisor. Responsible for randomization, data management, auditing, supervising clinical 
procedure, and final thesis revision. 
2. Dr. Nesma Mohamed Awaad (NA) 
− Assistant Professor of Prosthodontics, Faculty of Dentistry, Cairo University. 
− Co-supervisor. Responsible for outcome assessment, data collection, providing technical expertise in 
clinical trial design, designing the splints and thesis revision. 
3. Nour El Hoda Mahmoud Naguib El Tarabishi (NT) 
− Researcher and principal investigator responsible for all the clinical and laboratory work. 
− Writing the protocol and the final thesis. 
5.b   Name and contact information for the trial sponsor 
          Nour El Hoda Mahmoud Naguib El Tarabishi 
− Email: nourelhodaeltarabishi@dentistry.cu.edu.eg 
5.c Role of study sponsor and funders 
Department of Prosthodontics – Faculty of Dentistry – Cairo University is the sponsor of the trial. Without 
any influence on the study design or conduct, data collection, management, analysis or even data interpretation. 
The principle investigator will fund the implants and all the prosthodontics requirements of the research. 
 
 
 
 
 
 
 
 

 
2 
 
        5.d Role of the steering committee: 
 
Role of the steering committee 
− 
Department of Prosthodontics, Faculty of Dentistry - Cairo University. 
 
It is responsible for ensuring that the research idea follows the research plan of the department. 
 
− 
Evidence-Based Committee, Faculty of Dentistry - Cairo University. 
 
It is responsible for: 
 
− 
PICO revision. 
− 
Protocol revision. 
− 
Revise the reported methodology. 
− 
Medical biostatistics Unit (MBU) 
− 
It is responsible for sample size calculation and reporting of statistical methods. 
− 
The Ethical Committee, Faculty of Oral and Dental Medicine - Cairo University 
 
It is responsible for: 
 
− 
Ensuring that the trial does not violate privacy, ethical issues, or human rights. 
− 
Supplying the main investigator with a template of informed consent. 
− 
Approving the research, once it fulfils the required ethical criteria. 
− 
Faculty and University Board 
 
It approves the protocol once it is approved by the previously mentioned boards and committees. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
3 
 
II. Introduction: 
6. Background and rationale: 
Statement of the problem:  
 
Full arch implant restorations are a vital treatment option to rehabilitate complete edentulism. Prosthetic 
complications in full-arch titanium frameworks with zirconium overlays are prevalent, often resulting in increased 
patient morbidity and higher clinical workload. Traditional impression techniques are time-consuming and pose 
accuracy challenges, potentially contributing to these issues (Yuzbasioglu et al., 2014; Bandiaky et al., 2022). 
There is a need to explore alternative methods that can provide comparable or superior outcomes with improved 
efficiency. 
In this study intraoral scanning (IOS) and intraoral photogrammetry (IOP) will be compared. The comparison 
aims to evaluate if there is a difference in scanning time and prosthetic complication events between the two 
technologies regarding full-arch titanium framework with zirconium overlay.  
 
Rationale for conducting the research: 
IOS and IOP are emerging technologies in the field of prosthodontics that offer potential benefits over 
traditional impression techniques. These methods are becoming increasingly prominent due to their potential to 
enhance accuracy, reduce patient discomfort, and improve workflow efficiency (Yuzbasioglu et al., 2014; 
Bandiaky et al., 2022). The use of IOS and IOP for full-arch implant-supported prostheses, specifically with 
titanium frameworks and zirconium overlays, prompts examination of their impact on prosthetic outcomes such as 
scan times and complication rates. 
Traditional impression techniques are time-consuming and pose accuracy challenges, potentially contributing 
to these issues (Joda et al., 2021). Prosthetic complications in full-arch titanium frameworks with zirconium 
overlays are prevalent, often resulting in increased patient morbidity and higher clinical workload (Gao et al., 
2024). There is a need to explore alternative methods that can provide comparable or superior outcomes with 
improved efficiency (Ma et al., 2023). 
By comparing IOS and IOP, this research aims to determine whether these modern techniques can affect scan 
time and prosthetic complications. Such findings would be valuable for practitioners seeking to optimize clinical 
outcomes and streamline workflows, ultimately enhancing patient care and satisfaction. 
 
Review of literature:  
Intra-oral scanning (IOS) and intra-oral photogrammetry (IOP) have revolutionized the field of prosthodontics 
by offering a digital alternative to conventional impression-making techniques. These technologies provide 
numerous benefits, including enhanced accuracy, reduced patient discomfort, and streamlined workflows (El 
Hussieny fayad et al., 2024). The clinical utility of IOS and IOP has been widely explored in various dental 
contexts, yet their specific impact on full-arch implant-supported prostheses requires further investigation. 
Recent studies have compared the accuracy of IOS and IOP with conventional impression techniques. A study 
by Ma et al. (2021) demonstrated that for complete-arch implant rehabilitation, the IOP system showed the highest 
accuracy in terms of trueness and precision, followed by conventional techniques, and IOS providing the less 
accurate results (Ma et al., 2021).  
Scan time is a critical factor when considering the overall efficiency and patient experience in prosthodontic 
treatments. The study by Lawand et al. (2022) evaluated the effect of implant scan body modifications on the 
trueness and scan time of complete-arch intraoral scans (Lawand et al., 2024). The results indicated that certain 
modifications could enhance scanning speed while maintaining accuracy. Eldabe and Botros (2025) also stressed 

 
4 
 
the importance of scan bodies in improving the ease and trueness of full-arch implant scans, which can potentially 
reduce scan times and related prosthetic complications (Eldabe, Adel-Khattab and Botros, 2025). 
Prosthetic complications in full-arch implant-supported prostheses can arise from several factors, including the 
impression technique used. Research by Patel et al. (2023) highlights that while immediate placement and loading 
of implants yield successful outcomes, the associated prosthetic complications demand vigilant management across 
all treatment phases (Patel et al., 2023). Further, studies have suggested that the accuracy of impression techniques 
significantly impacts prosthetic fit, which in turn influences complication rates. 
Framework materials play a pivotal role in the success of full-arch implant-supported prostheses. Delucchi et 
al. (2021) conducted a systematic review to analyze the clinical outcomes of different framework materials used in 
full-arch implant prostheses (Delucchi et al., 2021). The study found that materials like titanium and zirconia 
showed high cumulative survival rates and favorable outcomes, while highlighting the need for long-term studies 
to validate these findings (Delucchi et al., 2021). 
The clinical performance of prostheses with titanium frameworks and zirconium overlays has been the subject 
of various studies. A study by Papaspyridakos et al. (2020) evaluated the complication rates and survival outcomes 
of full-arch implant-supported prosthesis (Papaspyridakos et al., 2020). The research indicated that while these 
prostheses offer promising results, they are not devoid of complications, necessitating continuous clinical evaluation 
and refinement of techniques. 
This literature review underscores the need for comprehensive research on the impact of IOS and IOP on scan 
time and prosthetic complications in full-arch implant-supported prostheses. Understanding these aspects can lead 
to optimized treatment protocols, reduced patient morbidity, and enhanced clinical outcomes. 
 
Explanation for choice of comparator 
The adoption of intraoral scanners (IOS) for full-arch implant-supported prosthesis rehabilitation has been 
validated through multiple recent studies, highlighting improvements in accuracy, efficiency, and patient comfort. 
Research indicates that full-arch digital impressions achieved through IOS may rival traditional methods, with 
various studies supporting the transition to fully digital workflows in implant dentistry. 
Recent studies have demonstrated the validity of intraoral scanners (IOS) in capturing precise and accurate full-
arch digital impressions. For instance, in a systematic review and meta-analysis by Floriani et al. (2023) nine studies 
were analyzed and the authors reported that IOS were more accurate in recording full arch implant supported 
prosthesis digital impressions compared to conventional physical impressions. The IOS presented 137.86 μm 
compared to 182.51 μm for conventional impressions (Floriani et al., 2023). The previously mentioned value is 
below the minimal acceptable clinical difference of 200 μm. This validates IOS as a reliable tool for full-arch 
impressions, establishing it as a benchmark for comparison. 
 
An invitro study compared the trueness and precision of PG, IOS, and conventional splinted open-tray 
impression technique. Each impression technique was performed 10 times on a master cast containing six implant 
abutment replicas. Standard tessellation language files (STL files) for all impression techniques were investigated 
after digitizing the master casts obtained from the conventional impression technique by a benchtop scanner. Results 
showed that accuracy of the PG system was highest followed by the conventional and IOS impression techniques 
(Ma et al., 2021). Evidently there is a need to investigate PG and IOS for scanning full -arch implant cases.  
Sinada & Papaspyridakos (2021) emphasize the integral role of intraoral scanners in providing accurate 
full-arch digital impressions necessary for creating CAD/CAM verification jigs. Their findings suggest that 
while the accuracy of such impressions depends on advances in scanning technology, existing clinical evidence 

 
5 
 
indicates that IOS performance for full-arch impressions has improved significantly, making them comparable to 
conventional methods (Sinada and Papaspyridakos, 2021).  
Furthermore, a study by Meneghetti et al. (2021) illustrated substantial advancements in techniques and 
workflows, integrating IOS with other technologies such as photogrammetry to improve outcomes for complete-
arch restorations. This holistic approach to digital processes exemplifies the shift toward fewer clinical steps and 
enhanced patient experiences (Meneghetti et al., 2021). The common theme is an increasing consensus 
regarding the feasibility and accuracy of full-arch rehabilitation using intraoral scanners, despite occasional 
challenges noted in specific clinical scenarios. 
In conclusion, the recent literature consistently highlights the efficacy and evolving accuracy of intraoral 
scanners in full-arch implant-supported prosthesis rehabilitation. As digital technologies advance, it is expected 
that their integration into routine dental practice will enhance the precision of prosthetic reconstructions and 
streamline overall workflows in implant dentistry. 
Research question:  
What is the effect of intra-oral photogrammetry on scan time and prosthetic complications in patients receiving full-
arch titanium framework with zirconium overlay implant screw-retained prostheses as compared to intra-oral 
scanning? 
 
7. Objectives: 
This study aims to evaluate the effect of intra-oral scanning and intra-oral photogrammetry on scan time and 
prosthetic complications in patients receiving full-arch titanium framework with zirconium overlay implant screw-
retained prostheses. 
Hypothesis:  
The null hypothesis is that there is no difference between intra-oral scanning and intra-oral photogrammetry on 
scan time and prosthetic complications in patients receiving full-arch titanium framework with zirconium overlay 
implant screw-retained prostheses. 
 
 
 
Primary objective: 
P: Full-arch titanium framework with zirconia overlay screw-retained prosthesis. 
I: Intra-oral Photogrammetry. 
C: Intra-oral scanning. 
O1: Scan time. 
O2: Prosthetic complications. 
 
8. Trial design: 
Parallel group, two arm, and superiority trial with 1:1 allocation ratio.  
 
III. Methods 
A) Participants, interventions & outcomes 
9. Study settings: 
Out clinic patients of department of prosthodontics – Cairo university 

 
6 
 
10. Eligibility criteria: 
Inclusion criteria: 
− Patients requiring maxillary and/or mandibular full arch screw-retained implant-supported prosthesis. 
− Number of implants placed per arch ranging from 4-6 implants per arch. 
− Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height 
space 9-15 mm per arch).  
− Adequate zone of keratinized mucosa (> 2mm width). 
− Both genders. 
− Acceptable oral hygiene. 
− Cooperative patients. 
− Controlled systemic diseases (Diabetes, hypertension). 
Exclusion criteria: 
− Completely edentulous patients with insufficient inter-arch space to receive fixed prosthesis (Crown height 
space lesser than 9mm per arch). 
− Completely edentulous patients with in-adequate zone of keratinized mucosa (< 2mm).  
− Un cooperative patients. 
− Poor oral hygiene. 
− Uncontrolled systemic diseases (Diabetes, hypertension). 
11. Interventions 
Completely edentulous patients that have received dental implants 1and ready to start prosthetic steps of full 
arch screw retained prosthesis will be recruited and randomly divided into two groups. 
 
 
IOS group (control group): 
IOS will be performed using commercially available IOS device. The scan data will be used to design and fabricate 
the full-arch screw-retained titanium framework with a zirconia overlay. 
- 
Intra-oral scanner2 will be used in the study to take a digital impression for the implants.  
- 
3D printed generic Scan bodies3 with unified shape and length replacing the traditional transfer copings will 
be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture 
their position and intra-oral scanning will be done. 
- 
With scan bodies in place, bite will be registered where, in case of completely edentulous upper and lower 
arches a 3D printed centric holding device 4will be used to fix the vertical dimension at the desired height and 
the intra-oral scanner will capture the bite at this position, but in case of a completely edentulous arch opposed 
                                                        
1 Bredent, made in Germany/ Dentis , made in Korea/ Root, made in Switztherland/ Jdental , 
made in Italy./ Dual , Made in Egypt 
2 Medit i700, made in South Korea 
3 Phrozen Shuffle xl 3D printer, and its own resin material, made in Taiwan 
4 Phrozen Shuffle xl 3D printer, and its own resin material, made in Taiwan 

 
7 
 
by dentulous arch , a green stick jig will be customized anteriorly to hold vertical dimension at the desired height 
and intra-oral scanner will be used to record the bite bilaterally. 
- 
The time taken to complete the scan will be recorded.  
- The final prosthesis framework will be designed on the patient’s scan using dental wings. The framework 
will be milled form titanium and then a zirconium overlay will be constructed. 
-  The final prosthesis will be delivered to the patient. 
- Follow up of the patients will be done at 3 and 6 months to check if there are any prosthetic complications. 
 
IOP group (intervention group): 
IOP will be performed using a specialized photogrammetry system. The photogrammetry data will be used to design 
and fabricate the full-arch screw-retained titanium framework with a zirconia overlay. 
- 
Intraoral photogrammetry5 will be used in the study to take a digital impression for the implants.  
- 
The scanner will be used to record the soft tissue anatomy and trans-mucosal abutments. 
- 
3D Scan bodies6 will be fitted on the trans-mucosal abutments that are screwed on the implants to capture 
their position and scanning will be done. 
- 
A scan of the soft tissue and scan bodies will finally be conducted. 
- 
With scan bodies in place, bite will be registered where, in case of completely edentulous upper and lower 
arches a 3D printed centric holding device 7will be used to fix the vertical dimension at the desired height and 
the intra-oral scanner will capture the bite at this position, but in case of a completely edentulous arch opposed 
by dentulous arch , a green stick jig will be customized anteriorly to hold vertical dimension at the desired height 
and intra-oral scanner will be used to record the bite bilaterally. 
- 
The time taken to complete the scan will be recorded.  
- The final prosthesis framework will be designed on the patient’s scan using dental wings. The framework 
will be milled form titanium and then a zirconium overlay will be constructed. 
-  The final prosthesis will be delivered to the patient. 
- Follow up of the patients will be done at 3 and 6 months to check if there are any prosthetic complications. 
 
 
 
 
                                                        
5 3D Shining 
6 3D Shining Scan bodies 
7 Phrozen Shuffle xl 3D printer, and its own resin material, made in Taiwan 
 
 

 
8 
 
12. Outcomes: 
Scan time will be recorded during the digital impression procedure, as the time taken to complete the digital 
impression. Prosthetic complications (e.g., screw loosening, framework fracture, zirconia chipping) will be 
recorded at 3 and 6-month follow-up period post-delivery and we will manage complications at the time of 
prosthetic complication occurrence. 
 
Outcome 
How to measure 
 
When to measure 
 
Rationale for 
choice of outcome 
 
Unit of 
Measurement 
Scan time 
Time recorded by 
scanning software 
to complete the 
scanning process 
At the visit of final 
impression and bite 
registration 
To record the 
difference, if 
present, in time 
taken to complete 
the scan, for the 
sake of the patient 
and operator 
Seconds 
Prosthetic 
complications 
Clinical 
examination 
 
At 3, 6 months of 
delivery of final 
prosthesis 
 
Clinical outcome 
that has a direct 
effect on restoration 
success 
Number of events 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
9 
 
 
 
 
13. Participant timeline 
 
 
STUDY PERIOD 
 
Post-allocation 
Close-out 
TIMEPOINT 
-t1 
-t1 + 
1week 
0 
t1 
start of 
clinical 
procedures 
 
t1 +  
1 week 
 
t1 +  
2 weeks 
 
 
t1 +  
3 weeks 
 
t 1+4 
weeks 
 
t3 
3 months post 
prosthesis 
insertion 
Tx 
after 6 months 
from prosthesis 
insertion 
ENROLMENT: 
✔ 
 
 
 
 
 
 
 
 
 
Eligibility screen 
 
✔ 
 
 
 
 
 
 
 
 
Informed consent  
 
✔ 
 
 
 
 
 
 
 
 
Allocation 
 
 
✔ 
 
 
 
 
 
 
 
INTERVENTION: 
[IOS: 
full-arch 
screw-
retained 
titanium 
framework 
with 
a 
zirconia overlay] 
Scanning the arch 
 
 
 
✔ 
 
 
 
 
 
 
Jaw relation/Bite 
registration 
 
 
 
✔ 
 
 
 
 
 
 
Designing and 
manufacturing  
 
 
 
 
 
✔ 
 
 
 
 
Titanium framework try-in 
 
 
 
 
 
 
✔ 
 
 
 
Final prosthesis delivery 
 
 
 
 
 
 
 
✔ 
 
 
CONTROL: 
[IOP: full-arch screw-
retained titanium 
framework with a 
zirconia overlay] 
Scanning the arch 
 
 
 
✔ 
 
 
 
 
 
 
Jaw relation/Bite 
registration 
 
 
 
✔ 
 
 
 
 
 
 
Designing and 
manufacturing  
 
 
 
 
 
✔ 
 
 
 
 
Titanium framework try-in 
 
 
 
 
 
 
✔ 
 
 
 
Final prosthesis delivery 
 
 
 
 
 
 
 
✔ 
 
 
ASSESSMENTS: 
Scan time  
 
 
 
✔ 
 
 
 
 
 
 
Prosthetic complication 
 
 
 
 
 
 
 
 
✔ 
✔ 
 
 

 
10 
 
14. Sample size: 
Scan time will be assessed as the 1ry outcome, where Mean± SD values will be used for this outcome. Entry 
1will be the (mean difference between 2 groups, mean and standard deviation of group 1, proportion 1 or estimated 
prevalence) = 8.59±2.46, while entry 2 will be (standard deviation of control group, mean and standard deviation 
of group 2, proportion 2 or clinically important difference) =clinical important difference based on expert 
opinion=2. The used alpha level of significance will be 0.05 with an effect size used in calculation:0.6366 and an 
80% power of the study. The used statistical test will be Independent-t-test. Sample size calculation included 19 
implants per group, total=38 implants with an increased number for anticipated missing data: 15% to compensate 
for drop outs, 25 implants per group, total of 50 implants. 
 
15. Recruitment: 
Recruitment will be done by NT Patients will be selected from the outpatient clinic of Prosthodontics Department 
– Cairo University. The department patient’s database will be reviewed and possible candidates for the trial will be 
called. All patients satisfying eligibility criteria will be consecutively included in the study (consecutive sampling).  
 
B) Assignment of interventions 
16. Allocation: 
16a. Randomization: 
Block randomization using computer-generated random block sizes will be carried out by AK only. 
16b. Allocation concealment mechanism:  
The participants will be allocated into the two studied groups by computerized sequence generation using (Excel 
for Windows; Microsoft Corp). 
16c. Implementation 
AK is the person who will generate the allocation sequence and who is responsible for ensuring proper 
randomization and allocation concealment.  He is involved in neither the scanning procedure and prosthetic 
complication recording nor the data collection. 
 
17. Masking/blinding: 
The patients and operator not blinded to treatments. The statistician and outcome assessor (NA) will be blinded to 
the treatments. 
 
C) Data collection, management, and analysis: 
18. Data collection methods 
18. A. Plans for assessment and collection of outcomes: 
The collected data will include participants age, gender, previous medical and dental history, type of arch, number 
of implants per arch and outcomes data. NT will be responsible for data collection. The collected data whether 
personal or numerical will be stored on excel sheets as an electronic copy and printed hardcopy sheets. The outcome 
data regarding scan time and prosthetic complication will be recorded at the final impression stage and the planned 
follow up visits respectively. Numerical data will be presented as mean and standard deviation, all data will be 
reported at a 95% confidence interval and alpha level of significance of 0.05% 

 
11 
 
18. B Plans to promote participant retention and complete follow-up: 
• Telephone numbers and address of all subjects in the study will be recorded as a part of the signed consent. 
• All subjects will receive a phone call at the time of the pre-determined follow up dates. 
• Paying transportation fees. 
19. Data management: 
All paper sheets that are concerned with person or outcome data will be stored in a locked cabinet and in the 
computer at the Department of Prosthodontics. The excel sheets of the patient’s data will be stored in the computer 
of the Department of Prosthodontics - Faculty of Dentistry.  They will be password-protected. Password will be 
known to the principal investigator and supervisors only to prevent unauthorized access to data and double data 
entry. 
 
20. Statistical methods: 
Data will be analyzed using appropriate statistical software. Continuous variables will be compared using 
independent t-test or Mann-Whitney U tests. Categorical variables will be compared using chi-squared or Fisher’s 
exact tests. A p value < 0.05 will be considered statistically significant. 
 
D) Data monitoring: 
21. Monitoring 
AK will monitor the data. He will have access to the data and will report any harmful effects of the treatment and 
hence give guidance about modifying or discontinuing the trial. 
Stopping Guidelines: 
The following guidelines will be followed for excluding the patient from the trial: 
− The study will be discontinued if more than 40% of the participants suffered implant failure. 
− Failure of the participant to comply with trial requirements. 
22. Harms 
No harms are expected and any adverse actions will be reported and treated.  
Criteria for discontinuing 
− Any relevant deterioration in the health of the participant possibly affecting participation in the trial. 
23. Audit 
Auditing of the study will be done by the data monitoring principle (AK), who has the right to modify or discontinue 
the trial. 
 
 
 
 
 
 
 

 
12 
 
IV. Ethics and dissemination 
24. Research ethics approval 
Research ethics approval: This protocol will be reviewed, approved and agreed upon by the Ethics Committee 
[Research Ethics Committee Cairo University Faculty of Dentistry] and an approval number will be provided to the 
trial protocol. 
25. Protocol amendments 
Any modifications to the title, research question, interventions or methods of analysis in the protocol will be 
reported and agreed upon by the Prosthodontics Department, evidence-based committee and data monitoring 
principle. 
26. Informed consent 
The trial will be explained to the participants by the principal investigator. The researcher will discuss the 
interventions and possible harms with participants and obtain written consent (in Arabic) from the patients willing 
to participate in the trial. An appendix of the consent form is attached to the protocol. 
27. Confidentiality 
All study-related information will be stored securely. All participants' information will be stored in locked file 
cabinets in areas with limited access. Photos, reports, personal and administrative data forms will be identified by 
an ID number to maintain participant confidentiality. Records that contain names or other personal identifiers will 
be stored separately from study records and will be identified by a code number as well. Local databases will be 
secured with password-protected access system. 
28. Declaration of interest 
No conflict of interest is to be declared.  
29. Access to data 
Patients' data whether personal or outcome data are only accessed by the secretary of the Department and the data 
monitoring committee member (AK). This is important to prevent accidental data loss, double data entry and keep 
patients’ confidentiality. 
30. Post-trial care 
All patients will complete their treatment by the same operator at the outpatient clinic of the Department of 
Prosthodontics. The participants will be followed up by AK, NA and NT even after the trial ends to treat patient's 
complaints and prevent any possible complications.   
31. Dissemination policy 
Trial results will be available in the database department and a copy of the thesis will be available at the department 
library and at the official site of the Egyptian Universities Libraries Consortium. Final report of the trial will be also 
published in an international journal. 
 
 
 
 
 
 
 
 

 
13 
 
 
V. Appendices 
32. Informed consent 
 
Informed Consent of Volunteers 
 
Title of the Research (in Arabic): Scan Time and Complications of Prosthodontics Using Intraoral Scan vs. 
Intraoral Photogrammetry for Implant-Firmed Complete Dentures with Full Titanium Frame and Zirconia Cap: A 
Randomized Clinical Trial 
 
Objective of the Research: 
 
This study aimed to compare, if any, the difference in scan time and complications of prosthodontics using 
intraoral scan versus intraoral photogrammetry for implant-firmed complete dentures with full titanium frame and 
zirconia cap. 
 
Introduction to the procedure and its details (work plan): - A digital imaging scan of the patient's mouth will be 
performed. - The jaw will be scanned using intraoral scanning and intraoral imaging, and the scan time will be 
recorded. - The final prosthesis will be delivered. - Finally, the patient will be followed up with pre-scheduled 
appointments. - Direct benefit to the volunteer: 
 
- Obtaining a stable prosthesis on high-quality implants. - Scientific and general benefit of the research: - 
Determining the scan time and complications of prosthetics using intraoral scanning versus intraoral imaging for 
complete implant-supported dentures made of a full titanium frame with a zirconia cap. - Side effects, risk levels, 
and how to manage them: - Gum inflammation or ulceration resulting from failure to follow denture cleaning 
instructions. This will be addressed by emphasizing adherence to denture cleaning  
Patient's full understanding of the research steps: Reading [ ] Oral explanation [ ] Other [ ] 
 
- I have carefully read and understood the purpose and nature of this research study, and I understand what is 
necessary to carry out these procedures. 
 
- The investigating physician has informed me of the possible treatment alternatives to this research. 
 
- The investigating physician has informed me of all the potential risks of this research and how to manage them. 
 
- I consent to the imaging, recording, and all types of radiological examinations that must be performed in this 
study, provided that my identity is not disclosed. 
- I have provided an accurate report of my medical history. I have informed the doctor of all 
unusual health reactions or allergies to medications, foods, insect bites, anesthetics, dust, or any other 
substances, as well as any abnormal bleeding or other relevant health conditions. 
 
I declare that I am not participating in any other research from the beginning to the end of this study and that I 
will inform the investigating physician if I participate in any other research during this period. 

 
14 
 
 
I undertake to return any medical equipment used in the research upon its discontinuation or completion. 
 
After reviewing the available research information, the volunteer or their designated representative is free to 
choose whether or not to participate. If they agree, they should complete the required information. The volunteer 
has the right to withdraw from the research without giving reasons, provided that the researcher has the right to 
retrieve any medical equipment or instruments used for the research that are in the volunteer's possession (as 
designated by the researcher). 
 
The physician in charge of the research pledges to maintain the confidentiality of the volunteer's information, 
specifying the methods used to ensure confidentiality, such as replacing names with code numbers or blurring 
facial features in photographs, if possible (etc.). 
 
The volunteer has the right to keep a photocopy of the informed consent form for the research they volunteered 
for. 
 
Volunteer's Name: Date of Birth: 
National ID Number (if applicable) 
Parent or Guardian's Name (if applicable): National ID Number: 
Address: Phone Number: 
 
Date: 
 
Researcher's Signature:                                                                                   Date: 
 
Research Supervisor's Signature (in the case of theses):                                 Date: 
 
Data to be completed by the committee 
This research has been approved by the committee under 
number
                                                             
                                                                                                             
                                                                                                         
 
 
 
 
 
 
33. Biological specimens 
Not available. 
 
 
 
 
 
 

 
15 
 
 
 
VI. References  
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fabricated from digital scans or conventional impressions: A systematic review and meta-analysis’, Journal of 
Prosthetic Dentistry, 127(1), pp. 71–79. doi: 10.1016/j.prosdent.2020.09.017. 
Delucchi, F. et al. (2021) ‘Framework materials for full-arch implant-supported rehabilitations: A systematic 
review of clinical studies’, Materials, 14(12), pp. 1–18. doi: 10.3390/ma14123251. 
Eldabe, A. K., Adel-Khattab, D. and Botros, K. H. (2025) ‘Trueness of tooth modified scan bodies as a novel 
technique for edentulous full arch implant supported dental prosthesis: an in vivo prospective comparative study’, 
BMC Oral Health, 25(1). doi: 10.1186/s12903-024-05172-y. 
Floriani, F. et al. (2023) ‘Linear Accuracy of Intraoral Scanners for Full-Arch Impressions of Implant-Supported 
Prostheses: A Systematic Review and Meta-Analysis’, European Journal of Dentistry, 17(4), pp. 964–973. doi: 
10.1055/s-0042-1758798. 
Gao, Y. et al. (2024) ‘Knowledge structure and research hotspots on digital scanning for implant-supported 
complete-arch prosthesis: A bibliometric analysis’, Heliyon, 10(17). doi: 10.1016/j.heliyon.2024.e36782. 
El Hussieny fayad,  noha, Abofadle, A. and Bahig, D. essam (2024) ‘Accuracy of different digital data acquisition 
work flows for full arch maxillary implant prostheses (an invitro study)’, Egyptian Dental Journal, 70(1), pp. 
461–471. doi: 10.21608/edj.2023.245517.2763. 
Joda, T. et al. (2021) ‘Time-efficiency and cost-analysis comparing three digital workflows for treatment with 
monolithic zirconia implant fixed dental prostheses: A double-blinded RCT’, Journal of Dentistry, 113(July). doi: 
10.1016/j.jdent.2021.103779. 
Lawand, G. et al. (2024) ‘Effect of implant scan body geometric modifications on the trueness and scanning time 
of complete arch intraoral implant digital scans: An in vitro study’, The Journal of Prosthetic Dentistry, 131(6), 
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for complete-arch implant rehabilitation: an in vitro comparative study’, BMC Oral Health, 21(1). doi: 
10.1186/s12903-021-02005-0. 
Ma, J. et al. (2023) ‘Accuracy of digital implant impressions obtained using intraoral scanners: a systematic 
review and meta-analysis of in vivo studies’, International Journal of Implant Dentistry, 9(1). doi: 
10.1186/s40729-023-00517-8. 
Meneghetti, P. et al. (2021) ‘A fully digital approach for implant fixed complete dentures: A case report’, Journal 
of Esthetic and Restorative Dentistry, 33(8), pp. 1070–1076. doi: 10.1111/jerd.12798. 
Papaspyridakos, P. et al. (2020) ‘Technical Complications and Prosthesis Survival Rates with Implant-Supported 
Fixed Complete Dental Prostheses: A Retrospective Study with 1- to 12-Year Follow-Up’, Journal of 
Prosthodontics, 29(1), pp. 3–11. doi: 10.1111/jopr.13119. 
Patel, R. et al. (2023) ‘Differences in Dental Implant Survival between Immediate vs. Delayed Placement: A 
Systematic Review and Meta-Analysis’, Dentistry Journal, 11(9), pp. 1–16. doi: 10.3390/dj11090218. 

 
16 
 
Sinada, N. and Papaspyridakos, P. (2021) ‘Digitally Designed and Milled Verification Jigs Generated from 
Photogrammetry Data Acquisition: A Clinical Report’, Journal of Prosthodontics, 30(8), pp. 651–655. doi: 
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Yuzbasioglu, E. et al. (2014) ‘Comparison of digital and conventional impression techniques: Evaluation of 
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