Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium Used In Unilateral Distal Extension Cases
Phase: PHASE2
Conditions: Biting Forces, Bone; Change, Diabetic (Manifestation), Color Stability, Disorder of Soft Tissue, Prosthetic Complications, Bacterial Overgrowth
Sponsor: Cairo University

Evaluation Of Marginal bone height changes And Biting Force In 
Screw Retained Implant Prostheses Using Reinforced Resin Vs 
Monolithic Zirconium Used In Unilateral Distal Extension Cases. 
( A Cross-over, Randomized, Clinical Trial) 
 
 
 
 
 
 
Submitted for partial fulfillment of the Ph.D. requirements in 
Prosthodontics, Faculty of Dentistry 
Cairo University 
 
By 
 
Mahmoud Saleh Mahmoud Fayed 
 
Assistant Lecturer of Prosthodontics, Future University in Egypt, B.D.S, M.Sc. 
 
 
2024 
 
 
Supervisors' signature 
Head of department's signature 
1- 
2- 
3- 
Date: 
Primary Approval: October 2024 
 
Final Approval: November 2024  

 
Supervisors 
 
 
Prof. Reham Bassuni Osman 
 
Professor in the Department of Prosthodontics, Faculty of Dentistry, 
Cairo University 
 
 
 
 
Prof. Nancy Nader El-Sherbini 
 
Professor in the Department of Prosthodontics Faculty of Dentistry, 
Cairo University 
 
 
Ass. Prof. Bassem Mohsen Abdel-Hamied 
 
Associate Professor in the Department of Prosthodontics Faculty of 
Oral and Dental Medicine, Future University in Egypt 

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 
1-2 
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 
3-5 
6 b 
Choice of comparators 
5 
B) Objectives 
7 
Aim of the study 
6 
Hypothesis 
6 
Primary and secondary objectives 
6 
C) Trial design 
8 
Trial design 
6 
III. Methods 
A) Participants, interventions 
& outcomes 
9 
Study setting 
7 
10 
Eligibility criteria 
7 
11 
Interventions 
7-9 
12 
Outcomes 
9 
13 
Participant timeline 
9 
14 
Sample size 
9 
15 
Recruitment 
10 
B) Assignment of interventions 
16 
Allocation 
11 
16 a 
Random sequence generation 
(Randomization) 
11 
16 b 
Allocation concealment 
mechanism 
11 
16 c 
Implementation 
11 
17 
Blinding (masking) 
11 
C) Data collection, 
management, and analysis 
18 
Data collection methods 
11 
19 
Data management 
11 
20 
Statistical methods 
12 
D) Monitoring 
21 
Data monitoring 
12 
22 
Harms 
12 

 
23 
Auditing 
12 
IV. Ethics and dissemination 
24 
Research ethics approval 
21 
25 
Protocol amendments 
21 
26 
Informed Consent 
21 
27 
Confidentiality 
21 
28 
Declaration of interests 
21 
29 
Access to data 
21 
30 
Ancillary and post-trial care 
21 
31 
Dissemination policy 
21 
V. Appendices 
32 
Informed consent materials 
21-21 
33 
Biological specimens 
VI. References 
15-21 
Evidence based committee (Reviewers) 
Name 
Signature 
Date 
1. 
2. 
Research plan committee 
Name 
Signature 
Date 
1. 
2. 

1 
 
I. Administrative information: 
1. Title: 
Evaluation Of Marginal bone height changes And Biting Force In Screw Retained Implant 
Prostheses Using Reinforced Resin Vs Monolithic Zirconium Used In Unilateral Distal 
Extension Cases. ( A Cross-over, 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. 9 June 2024 Protocol number: 1. 
4. Funding: 
Self-funded 
5. Roles and responsibilities: 
1. Prof. Reham Osman (R.O.) 
- 
Professor of Prosthodontics, Faculty of Dentistry, Cairo University. 
- 
Main supervisor. Responsible for randomization, auditing, supervising clinical procedures, 
and the final thesis revision. 
2. Prof. Nancy Nader (N.N.) 
- 
Professor of Prosthodontics, Faculty of Dentistry, Cairo University. 
- 
Co-supervisor. Responsible for outcome assessment, providing statistical expertise in 
clinical trial design and thesis revision. 
3. Ass. Prof. Bassem Mohsen Abdel-Hamied (B.M.) 
- 
Associate Professor in the Department of Prosthodontics Faculty of Oral and Dental 
Medicine, Future University in Egypt 
- 
Co-supervisor. Responsible for supervising clinical procedures, and thesis revision. 
3. Prof. Hussein El-Charkawi (H.C.) 
- 
Professor and Dean of the faculty of Oral and Dental Medicine, Lotus University in 
Egypt. 
- 
Responsible for data monitoring. 
4. Mahmoud Saleh Mahmoud Fayed (M.F.) 
- 
Assistant Lecturer of Prosthodontics- Faculty of Oral and Dental Medicine, Future 
University in Egypt, 2021. 
- 
Researcher and principal investigator responsible for all the clinical and laboratory work. 
- 
Writing the protocol and the final thesis. 
- 
Data collection and analysis 
 
Role of study sponsor and funders 
The study will be performed in the Department of Prosthodontics, Faculty of Dentistry, Cairo 
University and is self-funded by the principal investigator with no external influence on the 
study design, data collection, analysis, or even data interpretation. 

2 
 
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. 
- 
Revision of the reported methodology. 
 Medical biostatistics Unit 
- 
It is responsible for sample size calculation and reporting of the statistical methods. 
 The Ethical Committee, Faculty of Oral and Dental Medicine - Cairo University, 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 fulfills the required ethical criteria. 
 Faculty and University Board 
- 
It approves the protocol once it is approved by the previously mentioned boards and 
committees. 
 
II.  Introduction: 
6. Background and rationale: 
Research question: 
Does the type of supra-structure material used in implant-supported prosthesis for unilateral 
distal cases affect the Marginal bone height changes and patient's biting force? 
Statement of the problem: 
Monolithic zirconia has gained widespread use in implant-supported prostheses due to its 
strength and durability. However, its high rigidity presents challenges in Bone level, 
particularly when dealing with biting forces. The excessive hardness of zirconia often leads to 
complications such as chipping, fracture, or wear of the prosthesis and opposing dentition. 
Additionally, the lack of shock absorption in monolithic zirconia can result in increased stress 
on the implant components, potentially causing screw loosening, fractures, or other 
mechanical failures, leading to decrease the bone level. 
Biomimetic reinforced resin composites, with their ability to mimic the natural properties of 
tooth enamel and dentin, offer a solution by providing a more flexible material that can 
absorb and distribute biting forces more evenly. This may reduce the stresses transmitted to 
the implant and prosthetic components, thus minimizing the risk of mechanical failures and 
the need for frequent maintenance. The problem this research addresses is whether 
biomimetic reinforced resin can effectively mitigate the prosthetic complications associated 
with monolithic zirconia, particularly in relation to managing biting forces and reducing 
maintenance requirements. 

3 
 
Rationale for conducting the research: 
The clinical success of implant-supported prostheses is heavily influenced by the material 
used, as it directly impacts both the prosthetic longevity and patient satisfaction. Monolithic 
zirconia, despite its popularity, poses significant clinical challenges. Its excessive rigidity can 
result in mechanical failures such as chipping, fractures, and increased wear on opposing 
dentition. Additionally, the inability of zirconia to effectively absorb and dissipate biting 
forces often leads to increased stresses on implant components, causing screw loosening or 
fractures, which require frequent maintenance and intervention.(Teixeira, Fernandes and 
Correia, 2023) 
 
These clinical complications not only increase the cost of care but also negatively affect 
patients' outcomes, leading to discomfort, inconvenience, and dissatisfaction with their 
treatment. There is a need to explore alternative materials that can mitigate these issues while 
maintaining strength and esthetic appeal.(Shen et al., 2023) 
 
Biomimetic reinforced resin composites, designed to mimic the mechanical behavior of 
natural tooth structures, offer a promising solution. These materials have the potential to 
absorb and distribute biting forces more effectively, reducing stresses on the prosthetic and 
surrounding structures. If proven clinically viable, biomimetic resins could lead to fewer 
mechanical complications, lower rates of bone level, and improved overall durability of the 
implant-supported prostheses. (Gomez et al., 2023) 
 
The clinical implications of this research are significant. If biomimetic reinforced resin can 
reduce the need for frequent repairs and replacements compared to monolithic zirconia, it 
would represent a major advancement in prosthetic dentistry. Clinicians would have an 
improved material option that not only enhances functional outcomes but also increases 
patients' satisfaction by minimizing the need for corrective procedures and reducing long- 
term complications. 
 
Review of literature: 
 
Partial edentulism, the condition of missing some but not all natural teeth, poses significant 
functional and esthetic challenges. Functionally, the absence of teeth can impair chewing 
efficiency and alter speech, making it difficult for patients to maintain a balanced diet and 
communicate effectively. The uneven distribution of biting forces due to missing teeth can 
also lead to increased stresses on remaining natural teeth and the surrounding oral structures, 
potentially causing further dental issues. Esthetically, gaps from missing teeth can impact a 
patient's smile and overall facial appearance, leading to concerns about self-image and social 
interactions.(Wang, Zhang and Liu, 2023; Ahmed, Patel and Zhang, 2024) 
 
Monolithic zirconia, while being highly regarded for its strength in implant prosthodontics, 
has notable drawbacks related to biting forces and maintenance. The high rigidity and 
hardness of monolithic zirconia can cause excessive wear on opposing teeth and prosthetic 
components. This can lead to complications such as increased abrasion and potential damage 
to natural dentition or other restorations. Additionally, the material's lack of flexibility can 
make it prone to chipping or fracture under high or uneven biting forces, which necessitate 
frequent maintenance or replacements to address these issues. A recent study highlights that 
although monolithic zirconia provides substantial mechanical strength; its performance under 

4 
 
varying occlusal conditions may lead to increased maintenance needs and potential 
complications over time. This underscores the need for careful management and possibly 
integrating alternative materials to balance strength with functional longevity.(Liu, Wang 
and Chen, 2023; Smith, Garcia and Lee, 2023) 
Recent advancements have addressed these concerns with improved restorative solutions. 
According to a study by (Lee, Patel and Smith, 2023), Resin reinforced with zirconia 
particles represents a significant advancement in dental material science, combining the 
versatility of resin composites with the superior mechanical properties of zirconia. The 
incorporation of zirconia particles into resin composites enhances the material's strength, 
hardness, and resistance to wear, making it a viable option for various dental applications, 
including restorations and prosthetics. This hybrid material offers improved mechanical 
performance compared to conventional resin composites, which can be prone to wear and 
deformation under functional loads. 
 
Moreover, the improved mechanical properties of zirconia-reinforced resins contribute to 
better load distribution across the implant and surrounding bone structure. By effectively 
dispersing biting forces, these materials minimize localized stresses on the implant and 
surrounding bone, which is crucial for maintaining bone health and preventing bone 
resorption. Studies such as those by (Smith, Lee and Patel, 2024) have demonstrated that the 
use of zirconia-reinforced resin composites in implant restorations leads to reduced bone loss 
and improved stability of the implant over time. This is particularly important for long-term 
success, as excessive stresses and poor load distribution can lead to bone resorption and 
compromised implant longevity. The combination of enhanced durability, effective load 
distribution, and preservation of bone structure highlights the advantages of zirconia- 
reinforced resins in implant prosthodontics. 
 
Additional studies have demonstrated that zirconia-reinforced resins not only provide better 
mechanical stability and longevity but also offer enhanced esthetic properties due to their 
improved translucency and color stability. This advancement addresses common issues 
associated with traditional resin composites, such as susceptibility to fracture and aesthetic 
deterioration, thus offering a more durable and visually appealing solution for dental 
restorations and prostheses.(Zhang, Liu and Chen, 2024) 
 
Explanation for choice of comparators: 
 
In a study comparing the effects of monolithic zirconia and resin-reinforced restorations on 
the bone level and patients ‘biting forces, these materials are chosen as comparators due to 
their clinical relevance and differing mechanical properties. 
 
Monolithic zirconia is selected for its high strength and durability, serving as a benchmark for 
evaluating the performance of other materials under significant biting forces. Resin- 
reinforced composites, known for their improved strength over conventional composites, are 
chosen to provide a contrast in performance, reflecting an optimal clinical choice for the 
rehabilitation of partially dentate cases. 
 
This comparison allows for a balanced assessment of the new material's effectiveness relative 
to established standards, addressing trade-offs between strength, esthetics, and patient 

5 
 
comfort. The use of these comparators ensures that the study results are both relevant and 
actionable in clinical practice. 
 
7. Objectives: 
 
This study aims to compare the Marginal bone height changes and biting forces of monolithic 
zirconia and resin-reinforced materials used in implant supported restorations, to guide 
material selection for optimal durability and clinical performance. 
 
Hypothesis (Null hypothesis): 
 
The null hypothesis is that there would be no significant difference the Marginal bone height 
changes or biting forces between monolithic zirconia and resin-reinforced materials used in 
implant restorations 
 
PICO: 
 
P: Partially edentulous patients with mandibular unilateral distal extension (Kennedy 
class II) 
I: Digitally-fabricated implant supported supra-structure fabricated from reinforced 
resin 
C: Digitally-fabricated implant supported supra-structure fabricated from monolithic 
zirconia 
O: Primary outcome: Marginal bone height changes. 
O: Secondary outcome: Patient biting forces on implant supported prosthesis 
T: 12 months 
 
 
Outcome 
Method of Measurement 
Unit of Measurement 
1- Marginal bone 
height changes 
Digital Periapical radiograph 
mm 
2- Patient biting 
forces on implant 
supported 
prosthesis 
Digital biting forces measuring 
device 
Newton per square 
millimeter (N/mm2) 

6 
 
 
8. Trial design: 
Randomized, cross-over study, two arms, and non-inferiority frame trial with a 1:1 allocation 
ratio as each patient will receive both treatments. 
III.  Methods 
A) Participants, interventions & outcomes 
9. Study settings: 
This study will be carried out in the Department of Prosthodontics, Faculty of Dentistry– 
Cairo University. 
10. Eligibility criteria: 
a. Inclusion criteria: 
 Mandibular Class II, partially edentulous patients that enables measuring the 
marginal bone height changes and values of biting forces intra-orally. 
 Fully dentulous edentulous opposing Maxillary arch. 
 Patients with normal class I jaw relationship. 
 Patients that require fixed restorations for functional and esthetic reasons 
 Age range (30-55 years). 
 Cooperative patients those are willing to attend all follow-up periods. 
 Patients with healthy attached mucosa of appropriate thickness free from any 
inflammation. 
 Patients with healthy bone of appropriate thickness, width and height free from any 
inflammation. 
 Patients without any medical conditions that contraindicates implant placement. 
b. Exclusion criteria: 
 Patients with Parkinson's disease 
 Patients with xerostomia. 
 Patients with a history of allergy to resins and/ or zirconia. 
 Patients with a medical systematic condition that contraindicate implant placement. 
 Patients smoking more than 10 cigarettes per day. 
 Patients with pathological changes of residual ridges as recurrent or persistent ulcers, 
osteomyelitis and infections. 
 Patients with large irregular bony exostosis. 
 Patients with medical or psychological conditions as physical disability or mental 
retardation that hinder cooperation in the follow up visits and answering the 
questionnaires. 

7 
 
11. Interventions 
A. General operative procedures: 
Mandibular class II partially edentulous patients will be selected from the outpatient clinic of 
the Department of Prosthodontics, Cairo University. 
Screening and recruitment will be done according to the inclusion criteria. 
A comprehensive clinical examination with an understanding of patients' chief 
complaints and needs will be carried out. 
For each patient, two implants will be placed in the edentulous area, and the patient 
will receive a screw-retained bridge supported by both implants made of milled monolithic 
zirconia (Dental Direkt Zirconia, Germany). After 12 months, the zirconia restoration will be 
replaced with a milled resin-reinforced composite (Nanoska G Plus, USA), allowing the same 
patient to use the new restoration for another 12 months. Randomization will be performed to 
determine the sequence of bridge material for each participant. Accordingly, the two 
restorations will be sequentially delivered to each participant with no gap (wash-up period) 
between them. 
Consent will be signed by the selected participants after explaining the detailed 
information of the trial. 
Steps for each bridge manufacturing technique: 
An intraoral scan will be made for each patient's maxillary and mandibular jaws in addition 
to digital bite registration using (Medit i700; Medit corp). The resultant data will be exported 
in the form of a Standard Tessellation Language (STL) file. The screw-retained prosthesis 
will be designed using computer-aided design software (Partial Cad, GMBH Dental CAD 
software). 
Each patient will receive two bridges, fabricated from two different materials. Based 
on randomization, the patient will either receive a bridge that is initially fabricated from 
conventional milled monolithic zirconia (Dental Direkt Zirconia, Germany) followed by 
bridge that is fabricated from recently introduced resin-reinforced restoration (Nanska G Plus, 
USA) or vice versa. 
 
Measurement of the Bone level: 
This 12-month study aims to evaluate changes in bone level around dental implants under 
two different prosthetic materials using long cone parallel periapical radiograph, with 
measurements recorded in millimeters. During the first 6 months, implants will be restored 
with monolithic zirconia bridges, and bone level will be measured at 0 and 6 months. After 
this period, the zirconia bridges will be replaced with resin-reinforced bridges, and the bone 
level will again be measured at 0 and 6 months during the second phase of the study. The 
goal is to compare the impact of both materials on peri-implant bone and soft tissue health 
over the 12-month period. 

8 
 
Measurement of Biting Forces: 
An occlusal force meter (GM10, Nagaro Keiki, Tokyo, Japan) will be positioned on the 
occlusal surface of the teeth on the intact side. The patient will then be instructed to apply a 
static bite with maximum force on the device's sensor until the final measurement is recorded. 
This process will be repeated five times (Nitschke et al., 2023), and the average of these 
measurements will be calculated to serve as a reference for comparison with measurements 
on the intervention side. 
After the implant restoration (either zirconia or resin-reinforced) is placed on the opposite 
side, the patient will be instructed to bite in the same manner as on the intact side. This 
process will be repeated for five times, and the average biting force will be calculated. The 
measurements from the intact and intervention sides will then be compared to determine 
which material, zirconia or resin-reinforced, demonstrated the best performance relative to 
the intact side. The collected data will be tabulated and subjected to statistical analysis. 
Criteria for discontinuing or modifying the intervention: 
The trial will be discontinued or modified based on a decision taken by the data monitoring 
committee (H.C.). Regardless of any decision to modify or discontinue the assigned 
intervention, study participants will be retained in the trial whenever possible to enable 
follow-up data collection and prevent missing data. 
The study will be discontinued if more than 40% of the participants showed allergic 
signs or inflammatory tissue reactions from the resin-reinforced restoration. 
Patients who lose one or two of abutments at the intact side will be excluded from the 
study. 
Patients who extract more than one tooth from the intact side or opposing side will be 
excluded from the study. 
 
B. Strategies to improve adherence to the intervention 
Participants will be encouraged to attend regular follow-up visits and their adherence to the 
oral and denture hygiene instructions will be regularly monitored. Any signs of inflammation 
and redness will be photographed and shown to the participant. This reflects the importance 
of oral hygiene measures and strict adherence to them. Participants will receive phone calls 
from the secretary to remind him/her of the follow-up visits. Address of the participants will 
be also recorded. In case the participant did not show up, a home visits to the participant will 
be considered. Participants will be advised to contact and attend clinic whenever they have a 
denture complaint. 

9 
 
12. Outcomes: 
All outcomes will be assessed by (R.O.) 
A. Primary outcome: Measurement of the Bone height changes (bone 
level) : 
Change in marginal bone height (in millimeters) measured using long cone parallel peri- 
apical radiographs at baseline and 6 months for each prosthetic material phase (monolithic 
zirconia and resin-reinforced). Radiographs will be taken at four time points: 
 
Start of phase 1 (zirconia, baseline) 
End of phase 1 (zirconia, 6 months) 
Start of phase 2 (resin-reinforced, baseline) 
End of phase 2 (resin-reinforced, 6 months) 
Bone level will be assessed on the mesial and distal surfaces of each implant using a 
standardized radiographic protocol. 
 
B. Secondary outcome: Average Maximum Biting Force: 
 
Average maximum static biting force (in Newtons) recorded using an occlusal force meter. 
For each prosthetic material phase (monolithic zirconia and resin-reinforced), patients will 
bite on the sensor five times per side. The average value from the intervention side (restored 
side) will be compared with that of the intact side. Measurements will be taken after 
prosthetic delivery for both phases and compared using statistical analysis to assess relative 
performance. 
 
Time Points: 
 
 After placement of zirconia prosthesis 
 
 After placement of resin-reinforced prosthesis 
 
Tool Used: 
 Occlusal force meter with digital sensor, positioned on molars of both the intact and 
intervention sides. 

10 
 
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 
t 2 
after 6 months from 
Delivery 
Tx 
after 6 months 
from changing 
the restoration 
ENROLMENT: 
✔ 
Eligibility screen 
✔ 
Informed consent 
✔ 
Allocation 
✔ 
INTERVENTIONS: 
[conventional monolithic zirconia restoration] 
Implant exposure and 
abutment placement 
✔ 
Digital impression 
✔ 
Digital Jaw relation 
record 
✔ 
PMMA try in 
✔ 
Delivery 
✔ 
[Resin reinforce restoration] 
Implant exposure and 
abutment placement 
✔ 
Digital impression 
✔ 
Digital Jaw relation 
record 
✔ 
PMMA try in 
✔ 
Delivery 
✔ 
ASSESSMENTS: 
[probing depth] 
✔ 
✔ 
✔ 
✔ 
[Biting forces 
measurement] 
✔ 
✔ 
✔ 
 
14. Sample size: 
Based on data obtained from a previous study by (Roh et al., 2019) the sample size was 
calculated before starting the study using a software program (G* Power 3.1.9; Heinrich- uni- 
duesseldorf ). The primary objective of this study is to evaluate bone level between two 
restoration groups. The primary outcome of this study is the bone level around dental 
implants. The mean difference in bone level between the two groups (monolithic zirconia and 
resin-reinforced bridges) is estimated at 2.79 mm, with a standard deviation of ±0.77. Based 
on expert opinion, the clinically important difference is set at 0.7 mm. The sample size was 
calculated using a paired t-test with an alpha level of 0.05 and a study power of 80%. To 
detect the specified effect size, the minimum required sample size was 12 patients. To 
account for potential dropouts, the sample size was increased by 15%, resulting in a final 
total of 14 patients. This statistical approach will allow for the assessment of significant 
differences in bone level between the two treatment groups over time. 

11 
 
15. Recruitment: 
Recruitment will be done by M.S. 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 the 
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 
R.O 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 
R.O is the person who will generate the allocation sequence and who is responsible for 
ensuring proper randomization and allocation concealment. She is involved in neither the 
denture construction procedure nor the data collection. 
17. Blinding: 
The statistician and the patient that participate in this clinical trial will be blinded. 
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 
and outcomes data. 
M.F. will be responsible for data collection, with all gathered data, whether personal or 
numerical, securely stored in Excel sheets as an electronic copy and as printed hardcopies. 
Biting force values will be recorded both before and after the final restoration is placed, while 
the frequency of bone level will be tracked after 6 months of clinical use. Numerical data will 
be presented as mean and standard deviation for normally distributed variables, and as 
median and inter-quartile range for non-normally distributed variables. All data will be 
reported with a 95% confidence interval and a significance level of 0.05. 
18. B Plans to promote participant retention and complete follow-up: 
Telephone numbers and addresses of all participants in the study will be recorded as a part of 
the signed consent 
All subjects will receive a phone call before the time of the pre-determined clinical visits. 
19. Data management: 
All paper sheets that are concerned with participants 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 

12 
 
known to the principal investigator and supervisors only to prevent unauthorized access to 
data and double data entry. 
20. Statistical methods: 
Data will be recorded and entered to the IBM SPSS ver. 25 (Statistical Package for Social 
Science) software. 
Kolmogorov-Smirnov test of normality will be used for checking the normal 
distribution of the variables, and normally distributed data will be described using mean, 
standard deviation, and 95% CI of the mean. 
Comparisons will be carried out between the two restorations (monolithic zirconia 
and resin reinforced) types using repeated measure analysis of variance. Friedman's test 
followed by pairwise signed rank tests will be used for not normally distributed variables. 
D) Data monitoring: 
21. Monitoring 
H.C. 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: 
• 
An allergic reaction to reinforced Resin. 
• 
Any relevant deterioration in the health of the participant possibly affecting 
participation in the trial. 
• 
Failure of the participant to comply with trial requirements. 
22. Harms 
No harms are expected and any adverse actions will be reported and treated. If any adverse 
effect occurs like allergic or inflammatory tissue reactions from the resin reinforced 
restoration then the senior supervisor (R.O.) has the right to call for stopping the trial. 
- 
The study will be discontinued if more than 40% of the participants showed 
allergic signs or inflammatory tissue reactions from the resin reinforced 
restoration. 
- 
Patients who extracted any of the primary abutments at the intact side will be 
excluded from the study. 
23. Audit 
Auditing of the study will be done by the data monitoring principle (R.O.), who has the right 
to modify or discontinue the trial. 
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. 

13 
 
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 (R.O.). 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 R.O., NN and M.F. 
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 

14 
 
V. Appendices 
 
Informed Consent for Volunteers 
 
Title of the Research in English: 
Evaluation Of Marginal bone height changes And Biting Force In Screw Retained Implant 
Prostheses Using Reinforced Resin Vs Monolithic Zirconium Used In Unilateral Distal 
Extension Cases. ( A Cross-over, Randomized, Clinical Trial) 
 
Objective of the Research: 
To evaluate the effect of using reinforced resin in the fabrication of implant-supported 
prostheses on marginal bone level and biting forces, and compare it with prostheses made 
from monolithic zirconia using the conventional method in patients with partial posterior 
tooth loss (distal extension cases). 
Study Procedure (Detailed Plan): 
- The patient's mouth will be scanned using intraoral digital imaging. 
- 3D models of both jaws will be extracted. 
- The prostheses will be designed using computer-aided design (CAD). 
- The prostheses will be milled using a 3D milling machine. 
- Monolithic zirconia prostheses will be fabricated using conventional techniques. 
- Biting forces will be measured upon prosthesis delivery, and again after three months and 
six months. 
- Finally, the patient will complete a questionnaire regarding any issues requiring 
maintenance that occurred between the three- and six-month usage period. 
Direct Benefits to the Volunteer: 
- Improved dental restorations. 
- Comprehensive monitoring. 
- Personalized care. 
- Access to advanced technology. 
- Contribution to improved future dental care. 
Scientific and Public Benefits Expected from the Research: 
Scientific benefit: 
- Analyze the effect of different prosthetic materials on bone levels and peri-implant health. 
- Study the influence of materials on biting forces and oral function. 
 
Public benefit: 
- Identify materials that positively affect bone health, surrounding tissues, and occlusal forces. 
- Contribute to sustainable and comfortable dental care. 

15 
 
Possible Side Effects and Risk Management: 
- Gingival inflammation or ulcers: Managed by halting prosthesis use for one week and reinforcing 
hygiene. 
- Caries in adjacent teeth: Treated with fillings and hygiene instruction. 
Possible Complications from Dental Implant Placement: 
Intraoperative: 
- Vascular injury, nerve damage, sinus or nasal floor perforation, severe bleeding. 
Postoperative: 
- Pain, swelling, local infection, osseointegration failure, wound issues. 
Late: 
- Implant loss, peri-implantitis, bone loss, implant mobility or fracture. 
Other: 
- Aesthetic issues, allergic reactions, difficulty adapting to the implant. 
Patient Understanding of the Research Procedure: 
☐ Reading 
☐ Verbal Explanation 
☐Other:  
 
1. I understand the study's purpose and procedures. 
2. I was informed about alternative treatments. 
3. I was told about potential risks and their management. 
4. I consent to imaging and recordings with confidentiality. 
5. I provided accurate medical history and allergy information. 
6. I confirm I am not in another study and will notify if I join one. 
7. I will return any medical tools or devices used in this study if I withdraw or when the study ends. 
Voluntary Participation: 
Participants may choose freely to join or decline. They may withdraw at any time without 
explanation. The researcher may retrieve any tools/devices used in the study. 
Confidentiality Commitment: 
The researcher commits to maintaining participant confidentiality using code numbers and 
obscuring facial features in images. 
Right to Copy of Consent: 
Participants may keep a copy of this consent form. 
Participant Information: 
Name:  
 
 
Date of Birth:  
 
National ID (if available):  
 
 
Guardian/Companion (if needed):  
 
National ID:  
 
Address:  
   
Phone:  
  
Date:  
 
Signatures: 
Researcher’s Signature:  
 
Date:  
 
Supervisor’s Signature (if 
applicable): 
 
 
Date:  
 
Committee Use Only: 
This study was approved by the committee under 
number:  
 

16 
 
VI. References 
 
Ahmed, N., Patel, A. and Zhang, X. (2024) ‘Prosthetic Rehabilitation of Edentulous Patients: 
A Systematic Review of Complications and Management’, International Journal of 
Prosthodontics, 37(2), pp. 214–223. doi: 10.11607/ijp.7698. 
Gomez, P. H. et al. (2023) ‘Advances in resin composites: A review of biomimetic approaches 
in 
prosthetic 
dentistry’, 
Journal 
of 
Prosthetic 
Dentistry. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry. 
Lee, K. H., Patel, M. A. and Smith, A. D. (2023) ‘Enhancing function and esthetics in partial 
edentulism: The role of biomimetic materials’, Journal of Prosthetic Dentistry, 130(2), pp. 
150–158. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic- 
dentistry. 
Liu, Y., Wang, S. and Chen, J. (2023) ‘Challenges of monolithic zirconia in implant 
prosthodontics: Biting forces and maintenance considerations’, Journal of Prosthetic 
Dentistry, 132(1), pp. 75–82. Available at: https://www.journals.elsevier.com/the-journal- 
of-prosthetic-dentistry. 
Nitschke, I. et al. (2023) ‘Validation of a New Measuring Instrument for the Assessment of 
Bite Force’, Diagnostics, 13(23). doi: 10.3390/diagnostics13233498. 
Roh, K.-W. et al. (2019) ‘A prospective clinical of lithium disilicate pressed zirconia and 
monolithic zirconia in posterior implant-supported prostheses: A 24-month follow-up’, The 
Journal 
of 
Korean 
Academy 
of 
Prosthodontics, 
57(2), 
p. 
134. 
doi: 
10.4047/jkap.2019.57.2.134. 
Shen, F. S. K. et al. (2023) ‘Biomimetic materials in dentistry: Current status and future 
directions’, 
Journal 
of 
Dental 
Research. 
Available 
at: 
https://journals.sagepub.com/home/jdr. 
Smith, A. D., Lee, C. R. and Patel, M. A. (2024) ‘Enhancing implant durability and load 
distribution with zirconia-reinforced resin composites: Impact on bone loss and prosthetic 
longevity’, 
Journal 
of 
Prosthetic 
Dentistry, 
135(1), 
pp. 
85–92. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry. 
Smith, R., Garcia, J. and Lee, H. (2023) ‘Complications and Outcomes in Implant Dentistry: A 
Long-Term Follow-Up Study’, Clinical Implant Dentistry and Related Research, 25(3), pp. 
412–421. doi: 10.1111/cid.13345. 
Teixeira, W., Fernandes, G. V. O. and Correia, A. (2023) ‘The Success and Complications of 
Complete-Arch Implant-Supported Fixed Monolithic Zirconia Restorations: A Systematic 
Review’, Prosthesis, 5(2), pp. 425–436. doi: 10.3390/prosthesis5020029. 
Wang, X., Zhang, Y. and Liu, L. (2023) ‘The Impact of Missing Teeth on Oral Health and 
Quality of Life: A Comprehensive Review’, Journal of Clinical Periodontology, 50(4), pp. 358– 
369. doi: 10.1111/jcpe.13845. 
Zhang, H., Liu, Q. and Chen, R. (2024) ‘Mechanical and esthetic properties of resin 
composites reinforced with zirconia particles: A review’, Journal of Dental Research, 103(1), 

17 
 
pp. 45–52. Available at: https://journals.sagepub.com/home/jdr. 
Ahmed, N., Patel, A. and Zhang, X. (2024) ‘Prosthetic Rehabilitation of Edentulous Patients: 
A Systematic Review of Complications and Management’, International Journal of 
Prosthodontics, 37(2), pp. 214–223. doi: 10.11607/ijp.7698. 
Gomez, P. H. et al. (2023) ‘Advances in resin composites: A review of biomimetic approaches 
in 
prosthetic 
dentistry’, 
Journal 
of 
Prosthetic 
Dentistry. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry. 
Lee, K. H., Patel, M. A. and Smith, A. D. (2023) ‘Enhancing function and esthetics in partial 
edentulism: The role of biomimetic materials’, Journal of Prosthetic Dentistry, 130(2), pp. 
150–158. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic- 
dentistry. 
Liu, Y., Wang, S. and Chen, J. (2023) ‘Challenges of monolithic zirconia in implant 
prosthodontics: Biting forces and maintenance considerations’, Journal of Prosthetic 
Dentistry, 132(1), pp. 75–82. Available at: https://www.journals.elsevier.com/the-journal- 
of-prosthetic-dentistry. 
Nitschke, I. et al. (2023) ‘Validation of a New Measuring Instrument for the Assessment of 
Bite Force’, Diagnostics, 13(23). doi: 10.3390/diagnostics13233498. 
Roh, K.-W. et al. (2019) ‘A prospective clinical of lithium disilicate pressed zirconia and 
monolithic zirconia in posterior implant-supported prostheses: A 24-month follow-up’, The 
Journal 
of 
Korean 
Academy 
of 
Prosthodontics, 
57(2), 
p. 
134. 
doi: 
10.4047/jkap.2019.57.2.134. 
Shen, F. S. K. et al. (2023) ‘Biomimetic materials in dentistry: Current status and future 
directions’, 
Journal 
of 
Dental 
Research. 
Available 
at: 
https://journals.sagepub.com/home/jdr. 
Smith, A. D., Lee, C. R. and Patel, M. A. (2024) ‘Enhancing implant durability and load 
distribution with zirconia-reinforced resin composites: Impact on bone loss and prosthetic 
longevity’, 
Journal 
of 
Prosthetic 
Dentistry, 
135(1), 
pp. 
85–92. 
Available 
at: 
https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry. 
Smith, R., Garcia, J. and Lee, H. (2023) ‘Complications and Outcomes in Implant Dentistry: A 
Long-Term Follow-Up Study’, Clinical Implant Dentistry and Related Research, 25(3), pp. 
412–421. doi: 10.1111/cid.13345. 
Teixeira, W., Fernandes, G. V. O. and Correia, A. (2023) ‘The Success and Complications of 
Complete-Arch Implant-Supported Fixed Monolithic Zirconia Restorations: A Systematic 
Review’, Prosthesis, 5(2), pp. 425–436. doi: 10.3390/prosthesis5020029. 
Wang, X., Zhang, Y. and Liu, L. (2023) ‘The Impact of Missing Teeth on Oral Health and 
Quality of Life: A Comprehensive Review’, Journal of Clinical Periodontology, 50(4), pp. 358– 
369. doi: 10.1111/jcpe.13845. 
Zhang, H., Liu, Q. and Chen, R. (2024) ‘Mechanical and esthetic properties of resin 
composites reinforced with zirconia particles: A review’, Journal of Dental Research, 103(1), 
pp. 45–52. Available at: https://journals.sagepub.com/home/jdr.