Clinical Evaluation of Wear Resistance and Bioactivity of Self Cured Bioactive Resin Composite
Phase: NA
Conditions: Dental Caries, Class II Dental Caries
Sponsor: Suez Canal University

 
 
 
 
 
 
 Clinical Evaluation of Wear Resistance and Bioactivity of 
Self cured Bioactive Resin Composite.  
A Thesis Protocol  
Submitted for partial fulfillment of the requirements of the  
Doctor Degree in Dental Science of Conservative Dentistry 
Research code:  
Submitted By 
Nada Ismail Mohammed Saleh Hasan 
B.D.S., Suez Canal University, 2012 
M.Sc., Suez Canal University, 2022 
Assistant Lecturer in Operative Dentistry Department  
Faculty of Dentistry Sinai University 
Supervisors:  
Title 
Name 
Job Title 
University 
Signature 
Prof. 
Rehab Khalil 
Safy 
professor of 
Conservative 
Dentistry 
Suez Canal 
University 
 
Dr. 
Basma Hosny 
Mohamed  
Lecturer of 
Conservative 
Dentistry 
Suez Canal 
University 
 
 
Faculty of Dentistry  
Suez Canal University 
Year 2025 
 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
1 
 “Thesis Research Protocol” 
Student Name:  
Nada Ismail Mohamed 
Saleh Hassan 
Student 
ID: 
29004088800189 
 
 
 
 
Submission Date: 
Click or tap to enter a date. 
 
 
Degree: 
☐ 
M.D.Sc. 
☒  D.D.Sc 
☐ PH.D. 
 
 
 
 
 
Department: 
Operative dentistry 
 
 
Thesis Title in 
English: 
 Clinical Evaluation of Wear Resistance and 
Bioactivity 
of 
Self 
cured 
Bioactive 
Resin 
Composite. 
 
 
Thesis Title in 
Arabic: 
     
 
 التقييم السريري لمقاومة التآكل والنشاط الحيوي للراتنج
الحيوي المركب ذاتي التصلب. 
 
 
1. Abstract  
Introduction: 
       Resin-based composites (RBCs) have become the gold standard in 
restorative dentistry due to their superior aesthetics, adhesion, and 
minimally invasive application. However, wear remains a critical 
drawback, compromising their longevity and clinical performance. Various 
techniques have been suggested to measure the clinical performance of 
(RBCs). Recent advancements in digital dentistry, such as intraoral 
scanning, offer a more precise and efficient approach for quantitative wear 
assessment. 
Aim: 
         This study aims to evaluate wear resistance and bioactivity of self 
cured bioactive resin composite vs nanhybrid resin composite.  
 Methodology:  
         Twelve healthy patients with 24 carious molar teeth will be selected 
where each patient should have two oclusso- mesial cavities. Standardized 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
2 
oclusso- mesial cavities will be prepared for all the selected teeth, for each 
patient the first tooth will be restored with conventional nanohybrid RBC 
(M1). Meanwhile, the second tooth will be restored by self-cure bioactive 
RBC (M2). Then, wear resistance will be evaluated by intraoral scanner 
immediately after restoration (T0), six months later (T1), after 12 months 
(T2), 18 months (T3) and 24 months (T4). Software analysis will be done 
by superimposing the 3D digital impression and evaluate the restoration 
wear by calculating the 3D volume loss. 
Also, bioactivity of the restoration will be measured by measuring 
the mineral density beneath the restoration. Digital radiographic images 
will be taken for the restoration by parallel technique and grey scale of the 
pixels under restoration will be measured by software immediately after 
restoration (D0), one month later (D1) and after 3 months (D2). 
 
 
2. Introduction and Background 
Resin-based composites (RBCs) are currently the most widely 
used materials for dental restorations due to their favorable esthetics, 
mechanical properties, cost-effectiveness, versatility, and overall 
acceptable clinical performance. However, their long-term clinical 
durability remains a concern and requires further enhancement 
(Ferracane, 2024). 
Among the major causes of failure and replacement of resin 
composite restorations is secondary caries, with incidence rates 
reaching approximately 60%. This high rate highlights a significant 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
3 
limitation in the longevity of conventional resin based restorative 
materials (Pinto et al., 2023). 
In last few decades, bioactive resin composite materials have 
emerged as a trial to overcome such a problem. These materials are 
designed to release ions, such as calcium and phosphate, in a controlled 
and localized manner at the tooth-restoration interface. This ion 
exchange with surrounding saliva and tooth structure contributes to 
maintaining mineral balance and promoting remineralization, thus 
supporting tooth integrity and preventing its demineralization (Garcia 
et al., 2021). 
Recently, self cured resin based bioactive bulk fill material 
(Stela, SDI, Australia) was launched to the market as a recent 
bioactive RBC that contains fluoride, calcium and strontium for 
enhanced biomimetic and bioactive properties. Unfortunately, bioactive 
RBCs, vary significantly in formulation, particularly in terms of the 
type, size, and concentration of ion-releasing components. These 
differences influence their solubility, permeability, and ultimately their 
ability to sustain ion release over time. While such modifications are 
beneficial for caries prevention, they may also compromise the physical 
properties of such materials, especially wear resistance under 
continuous masticatory forces. This becomes even more critical 
considering that wear behavior of dental RBCs is highly dependent on 
their chemical constituents (Garcia et al., 2021). 
It is worth mentioning that occlusal wear is a critical factor 
affecting the success of posterior composite restorations. So that, high 
wear resistance is essential for maintaining the function and longevity 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
4 
of restorations. In contrast, poor wear resistance can lead to clinical 
complications such as tooth shifting, temporomandibular joint 
discomfort, and periodontal issues (Garcia et al., 2021). 
The manufacturer claimed that Stela is an innovative bioactive 
material with high strength properties. It offers an unlimited depth of 
cure and low-stress polymerization with a gap-free interface (SDI 
Limited, 2023). Therefore, the primary objectives of this study are to 
clinically evaluate the wear resistance and the bioactivity of such 
material. 
           Wear behavior of a micro hybrid composite vs. a nanocomposite 
in the treatment of severe tooth wear patients was evaluated. A 
convenience sample of 16 patients with severe tooth wear was chosen. 
Eight of them were treated with a micro hybrid composite (Clearfil 
APX, Kuraray) and the other eight with a nanocomposite (Filtek 
Supreme XTE, 3M). The Direct Shaping by Occlusion (DSO) 
technique was used for all patients. Clinical records were collected after 
1 month (baseline) as well as 1-, 3- and 5-years post-treatment. The 
maximum height loss at specific areas per tooth was measured with 
Geomagic Qualify software. The results showed that for premolar and 
molar teeth, Filtek Supreme showed less wear in bearing cusps, 
whereas Clearfil APX showed less wear in non-bearing cusps. They 
concluded that nanocomposite restorations showed significantly less 
wear at bearing cusps, whereas microhybrid composite restorations 
showed less wear at non-bearing cusps and anterior maxillary teeth 
(Ning et al, 2021). 
Remineralization effect of natural versus synthetic materials on 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
5 
deep carious dentin was studied. Extracted human molars with class I 
carious lesions were collected and randomly assigned into four groups: 
a control group, a propolis-treated group, a hesperidin-treated group, 
and a group treated with silver diamine fluoride (SDF). Carious tissues 
were managed using the stepwise caries removal approach, followed by 
application of the respective test materials. All cavities were then 
restored using glass ionomer cement (GIC). Radiographic evaluations 
were conducted at 6 and 12 weeks to assess changes in mineral density. 
Among the tested groups, the propolis group exhibited the greatest 
increase in mineral density, while the hesperidin group recorded the 
lowest with no significant difference. The findings suggested that both 
propolis and hesperidin demonstrated notable potential in enhancing 
dentin remineralization and limiting caries progression, presenting 
viable alternatives to SDF (Anani et al. 2023).  
          Clinical performance and wear resistance of milled  resin 
composite material versus direct nanohybrid  bulk‑fill resin composite 
in the restoration of  endodontically treated posterior teeth over 1 year 
was studied. Twenty-six patients with endodontically treated teeth were 
divided into two groups, where R1 restored with Milled composite, R2 
restored with direct bulk‑fill composite. Each restoration was assessed 
for wear resistance immediately and after one year intraorally and extra 
orally using intraoral scanners and three‑dimensional surface‑based 
superimposition software. They found that direct nanohybrid bulk-fill 
resin composite showed a greater amount of wear without a statistically 
significant difference. There was no significant reliability/agreement 
between both methods. They concluded that both milled composite and 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
6 
direct bulk-fill resin composite restorations in endodontically treated 
teeth demonstrated minimal wear over a 1-year follow-up period 
(Elhaddad et al, 2024). 
          An evaluation of dental paste-like bulk-fill composite wear using 
intra-oral scanner was done. Six different dental composite materials, 
including five bulk-fill composites and one conventional composite, 
were tested alongside natural human enamel as a control group. A 
computer-controlled chewing simulator was used for wear testing. A 
one-way ANOVA test was used to identify any significant differences 
between the means of the tested dental composite materials. The results 
showed 
variability 
among 
bulk-fill 
composites, 
with 
some 
demonstrating 
wear 
resistance 
like 
conventional 
composites. 
Significant variability was observed among bulk-fill composites, but 
the results were comparable to those of conventional composites. The 
enamel control group demonstrated the lowest wear values, with some 
bulk-fill composites showing similar wear resistance. The conclusion 
showed that significant variability was observed among bulk fill 
composites, but the results were comparable to those of conventional 
composites. The enamel control group demonstrated the lowest wear 
values, with some bulk-fill composites showing similar wear resistance 
(Baltacioglu et al., 2024). 
            The wear of dental restorations using an intraoral scanner and 
its correlation with visual assessment was evaluated prospectively. 
Thirty six patients were followed-up by intraoral optical impression and 
visual assessment over three appointments over 12 months, where T0 is 
the base line, T6 after 6 months, and T12 after 12 months. The results 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
7 
showed that: According to the visual indices, all restorations in this 
study were clinically healthy. However, in the digital measurement of 
wear, 94.74% and 94.44% of the restorations during the T0-T6 and T6-
T12 observation periods, respectively, showed deterioration greater 
than 41 microns. Discordant results were obtained in the correlation 
analysis. In T0-T6, the results were not considered statistically 
significant; however, the results obtained during T6-T12 showed a 
correlation. They concluded that wear of dental materials as observed 
by the human eye did not agree with that observed by intraoral 
scanning. The scanner effectively measures wear, detecting details that 
are beyond the capability of the human eye and conventional 
photographs (Urcelay et al, 2025). 
Digital and conventional methods of wear analysis using two 
hybrid ceramic materials were compared. Disc-shaped samples (2 mm 
thick and 10 mm in diameter) were prepared from Vita Enamic and 
Cerasmart materials and subjected to chewing simulation. Wear 
evaluation was conducted using two approaches: conventional weight 
loss assessment before and after simulation, and digital analysis via 
Geomagic software by superimposing 3D scan images taken with 
intraoral scanner. The results revealed a positive correlation between 
the conventional and digital measurement methods. Statistically 
significant differences were observed between the two materials in 
terms of wear behavior. Vita Enamic demonstrated considerably more 
wear than Cerasmart 270 across both evaluation techniques. They 
concluded that both weight-based and digitally calculated volume loss 
methods are reliable for wear assessment, with Cerasmart 270 showing 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
8 
superior resistance to wear compared to Vita Enamic (ElSharouny et 
al, 2025). 
 
3. Research Q (RQ): 
What is the difference between self cured bioactive and light cured 
nanohybrid (RBCs) regarding wear resistance and bioactivity after two 
years of clinical performance?  
4. Research Hypothesis, Aim, Objectives & Expected 
Outcomes 
a. Hypothesis  
Null hypothesis: There is no significant difference between wear 
resistance and  bioactivity between self cured bioactive RBC and light 
cured nano-hybrid one. 
b. Aim  
This study aims to evaluate wear resistance and bioactivity of self cured 
bioactive RBC in comparison to light cured nanohybrid one. 
c. Objectives 
1- Assessment of wear resistance of self cured bioactive RBC in 
comparison 
to 
light 
cured 
nanohybrid 
one.  
2- Evaluation of bioactivity of self cured bioactive RBC in comparison 
to light cured nanohybrid one. 
d. Expected Outcomes  
Self cured bioactive RBC could show slight lower wear resistance 
than light cured nano-hybrid RBC with remarkable bioactive potential. 
 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
9 
5. Research Design and Methods: 
I): Materials: All materials that will be used as well as their description, 
composition, and manufacturers are listed in (Table1). 
Table 1: The materials brand names, description, compositions and 
manufacturers: 
Material 
brand        
name 
Description 
Compositions 
Manufacturers 
 
STELA 
Primer 
 
primer 
10-MDP, 
dimethacrylates, 
methyl ethyl ketone 
(MEK), water, 
initiators, stabilizers. 
 
 
 
 
 
 
 
 
 
 
SDI Limited, 
Australia 
 
 
 
 
 
 
 
 
STELA 
 
 
Self cured 
bioactive 
bulk fill 
resin based 
composite 
Catalyst: barium-
glass, glass, ytterbium 
trifluoride (YbF3), 
silica, urethane 
dimethacrylate, 
initiators, stabilizers 
 
Base: strontium 
fluoroaluminosilicate 
glass, ytterbium 
trifluoride 
agglomerates (YbF3), 
silica, calcium 
aluminate (Al2CaO), 
urethane 
dimethacrylate, 
initiators, stabilizers 
 
Meta Etchant 
Acid 
Etching 
gel 
37% phosphoric acid, 
distilled water, and a 
colloidal Silica sol 
Meta Biomed, 
Korea 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
10 
All-bond 
uni- 
versal dental 
adhesive 
One step 
self-etch 
adhesive 
10-
methacryloyloxydecyl 
dihydrogenphosphate 
, Bisphenol A 
glycidyl dimeth-
acrylate, 2-
hydroxyethyl 
methacrylate, Etha- 
nol, Water, Initiators 
Bisco, INC 
Schaumburg, 
IL, USA 
Filtek™ 
Z250 XT 
Nano-hybrid 
resin 
composite 
Matrix: Bis-GMA, 
UDMA, Bis- EMA. 
Filler: Inorganic 
fillers : zirconia, silica 
78.5 wt %  
63.3 vol% 
3M ESPE 
St.Paul,M , 
USA 
II: Methods : 
II- 1 Study Setting : 
A randomized controlled double-blinded clinical trial will be 
conducted where both patient and examiners will be blinded to the group 
assignment. Patients of age group 21–45 years (Hirani et al, 2018) will 
be selected where each patient should have two oclusso- mesial cavities. 
Patients will be recruited from the outpatient clinic of Conservative 
Dentistry department in the Faculty of Dentistry, Suez Canal University. 
During the initial examination, the purpose and the method of the 
research will be explained to the patients and a written informed consent 
will be assigned by each individual. 
II-2 Sample Selection : 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
11 
Patients participating in this study will be selected according to the 
following eligibility criteria : 
II-2-a Inclusion Criteria: (Hirani et al, 2018). 
1. Patients with vital two molar teeth with compound class II deep 
carious lesions.  
2. Both males and females will be included.  
3. Patients with good general health.  
4. Patients with good oral hygiene.  
5. Co-operative patients.  
6. Absence of spontaneous pain, mobility or tenderness on 
percussion.  
7. Radiographically: no internal or external resorption, no periapical 
or furcation radiolucency and no widening of the periodontal 
ligament space.  
II-2-b Exclusion Criteria: (Hirani et al, 2018) . 
1. 
Patients with systemic decease. 
2. 
Patients with severe or chronic periodontitis. 
3. 
Patients have allergy to the materials used in this trial . 
4. 
Nonfunctioning teeth. 
5. 
Teeth with any pathologic pulpal changes . 
6. 
Teeth with previous restorations. 
7. 
Teeth with surface loss due to non carious lesions . 
All patients who will attend the clinic will receive the proposed 
treatment protocols. However, only those who will meet the inclusion 
criteria will be enrolled in the study and included in the trial. Patients who 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
12 
will not fulfill the inclusion criteria will also be treated but will be 
excluded from the study analysis. 
II-3 Cavity preparation:  
The same treatment protocol will be followed for all patients where 
each patient will receive two compound class II cavities in posterior 
molar teeth distributed in both sides. Local anesthesia will be 
administered in the beginning of the session and quadrant isolation will 
be administrated by rubber dam. Access through enamel and outline form 
will be obtained with a sterile high speed #245 bur. Following the 
international guidelines, all soft infected dentine will be removed, and a 
hard sound dentin floor should be reached. For the peripheries of the 
cavity, carious tissue removal to hard dentine will be performed using a 
sharp sterile spoon double-ended excavator and a low-speed round bur. 
The dentinoenamel junction, cavosurface margins and gingival box will 
be inspected carefully and to be clean, with at least 1.5 to 2 mm rim of 
peripheral sound tooth structure to provide a firm marginal adhesion for 
the restoration. 
II-4 Randomization: 
 
To minimize selection bias and ensure equal distribution of 
treatment protocol across both treated molars, simple randomization will 
be used to randomly determine which molar receives which material. 
Therefore, 
randomization 
will be 
performed 
using 
an online 
randomization tool (https://www.randomizer.org/) prior to treatment 
allocation where, each patient will be given a unique study number, 
ensuring that each patient receives both treatments in a randomly 
assigned manner. 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
13 
II-5 Restorative procedures:  
Each included patient with the already prepared cavities will 
receive two different types of restorations. where one of them will be 
restored with light cured nano hybrid RBC (Filtek™ Z250, 3M ESPE 
St.Paul,M ,USA) (M1) meanwhile, the second cavity will be restored with 
self-cure bioactive RBC (Stela, SDI, Australia) (M2). 
A sectional matrix system will be used to achieve proper proximal 
contour and anatomically correct contact with the adjacent tooth. Then, 
the restorative procedure of each cavity will be carried out according to 
the manufacturer's recommendations of each tested restoration. Before 
restoration each cavity will be carefully cleaned with copious air water 
spray before being dried. Restoration of (M1) group will be performed 
through selective etching of the prepared cavity enamel surface using 
37% phosphoric acid gel (Meta Biomed, Korea) for 15 seconds. This will 
be followed by rinsing with water for 15 seconds and gentle air drying for 
5 seconds, leaving the cavity slightly moist. After that, single layer of a 
universal adhesive bonding agent (Bisco, INC Schaumburg, IL, USA) 
will be applied to the prepared cavity walls and floor using disposable 
adhesive 
micro 
brush. 
The 
adhesive 
will be subsequently cured for 20 seconds using LED light curing unit 
(Elipar S10, 3M ESPE, St Paul, Minnesota, USA) with an intensity of 
1200 mW/cm2. The nano hybrid RBC (Filtek™ Z250) will be 
incrementally applied, and light cured according to manufacturer 
instructions. Finally, finishing and polishing of the restoration using one-
step polishing system (Dimanto, Voco, Germany). Then, checking of 
occlusion and proximal contacts will be done. 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
14 
 
Restoration of (M2) group will be performed through conditioning 
of cavities with a specialized primer (STELA primer, SDI, Australia) 
according to manufacturer instructions. Then, a self cured bioactive RBC 
(STELA, SDI, Australia) will be placed in a single increment and allowed 
to self-cure according to manufacturer instructions. Then, finishing and 
polishing of the restoration, checking the occlusion and proximal contacts 
will be done as mentioned before. 
II-6- Evaluation of the wear resistance: 
 
A digital impression will be taken immediately after restoration 
(T0) using an intraoral scanner (Helios 600 intraoral scanner, Eighteeth, 
Changzhou, China). To ensure optimal performance and accuracy, the 
scanner underwent regular calibration before scanning each patient, 
following the manufacturer's recommendations. During the scanning 
procedure, the device will be positioned at a 90° angle for the occlusal 
surface and at 45° angles for both buccal and lingual surfaces. Later on, 
each restoration will be examined at standardized follow-up periods 
(Table 2 and 3); six months (T1), twelve months (T2), eighteen months 
(T3) and twenty-four months (T4). The 3D impressions will be analyzed 
using a software (Geomagic software, 3D Systems Inc., USA) program 
and the impressions of each two consultative visits will be superimposed 
to determine the wear volume loss (mm3). (Bronkhorst et al, 2022) 
    II-7- Assessment of the bioactivity: 
 
Bioactivity of each examined restoration will be determined by the 
evaluation of mineral density beneath the tested materials. Immediately 
after restoration (D0), an image plate digital sensor (Xios XG Supreme, 
Dentsply Sirona, UK) will be used for transmitting the radiographic 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
15 
image of the selected tooth to the computer. A posterior parallel kit will 
be used for image standardization. Later, each restoration will be 
examined at standardized follow-up periods; one month (D1) and three 
months (D2) (Table 4 and 5). The image plate will be inserted at one end 
of the parallel kit, while the other end was connected to the x-ray cone. 
All the radiographs will be evaluated for the outcome by a software 
(ImageJ software, NIH, USA). The assessment of mineral density will be 
done by the software through performing the following measurements: in 
each image a line will be drawn along the CEJ to act as a reference, while 
another parallel line will be drawn at the bottom of the cavity. The 
distance between both lines will be standardized for each tooth by 
measuring the length of a vertical line connecting them. The length of the 
line centralized at the bottom of the cavity will be determined in pixels 
directly via the previously mentioned software. Such length will be fixed 
for each sample throughout assessment intervals. Three points on this line 
(at its start, middle and end) will be determined. The mineral density 
value at each of these points will be identified by taking the 
corresponding three readings from the software and recording them to 
calculate the average value. The mineral density mean value will be 
calculated from the software (Ibrahim et al, 2016). 
Table 2: Variables of the wear resistance test and levels of 
investigations: 
Variable
 
Level
 
Referred to
 
Type of material (M).
 
M1
 
Light cured nanohybrid RBC.

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
16 
M2
 
Self-cured bioactive RBC.                   
 
Time of follow-up (T). 
           
 
T0
 
Immediately after restoration.
T1
 
After six months.
T2
 
After twelve months.
T3
 
After eighteen months.
T4
 
After twenty-four months.
 
Table 3: Interaction between variables for wear resistance test: 
M
 
Type of material (M)
 
Total
 
M1
 
M2
 
Times 
 
(T)
 
T0
 
M1T0
 
M2T0
 
 
T1
 
M1T1
 
M2T1
 
 
T2
 
M1T2
 
M2T2
 
 
T3
 
M1T3
 
M2T3
 
 
T4
 
M1T4
 
M1T4
 
 
Total
 
10
 
10
 
20
 
Sample size: n= 10 
Table 4: Variables of the bioactivity test and levels of investigations: 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
17 
Variable
 
Level
 
Referred to
 
Type of material (M).
 
M1
 
Light cured nanohybrid RBC.
M2
 
Self-cured bioactive RBC.                   
 
Time of follow-up for 
mineral density (D).  
       
 
D0
 
Immediately after restoration.
D1
 
After one month.
D2
 
After three months.
Table 5: Interaction between variables for bioactivity test: 
M
 
Type of material (M)
 
Total
 
M1
 
M2
 
Times 
 
(D)
 
D0
 
M1D0
 
M2D0
 
 
D1
 
M1D1
 
M2D1
 
 
D2
 
M1D2
 
M2D2
 
 
Total
 
10
 
10
 
20
 
Sample size: n= 10 
6- Sample size calculation:  
Sample size calculation was performed using G*Power version 
3.1.9.2, (Faul et al, 2007) University Kiel, Germany. Copyright (c) 1992-
2014. 
 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
18 
 
 
 
Where:  
           f:  is the effect size; α= 0.05; β= 0.05; Power= 1- β = 0.80 
The effect size d was 1.22 (large) according to the previous studies 
(Elderiny et al., 2024) with alpha (α) level of 0.05 and Beta (β) level of 
0.05, i.e., power = 80%; the estimated sample size (n) should be 20 
samples and will be divided into two groups. 
To account for dropouts, the sample size will be expanded by 20%, 
which produced 12 restorations for each group instead of 10. 
 
    Statistical analysis:  
All collected data will be calculated, tabulated, and statistically analyzed 
using suitable statistical tests as follows: A normality test: will be done 
to check normal distribution for data by Shapiro-Wilk test. Descriptive 
statistics: will be calculated in the form of mean ± standard deviation 
(SD), range (Max-Min). Qualitative data will be presenting as (%) 
frequencies (n) and percentages. T- test or Mann-Whitney test 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
19 
(According to the types of data). Independent Student’s T-test or Mann-
Whitney will be performed for pair wise comparison between groups in 
each time at P value < 0.05. The Chi-square test will be used to test 
significance of association between categorical variables. Pearson's 
correlation coefficient: will be used for estimating the relationship 
between quantitative variables. P<0.05 is considered significant. 
Statistical analysis will be performed using the computer program SPSS 
software for windows version 26.0 (statistical package for social science, 
ARMONK, NY: IBM Corp). 
7. Ethics consideration:  
     The present research will be conducted after the approval of the 
Research Ethics Committee (REC) of the faculty of Dentistry, Suez Canal 
University. Ethical considerations regarding patient well-being and 
confidentiality will be undertaken by the researcher and informed written 
consent will be signed by the patients before commencing the study 
explaining all clinical examinations, procedures, and follow-up. 
(Attached appendix I) 
8. Time Plan  
Starting after approval of the ethical committee and faculty council.  
Ending after 24 months. 
Activity/Month  
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
Patient selection 
☒ ☒ ☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ 
Material application 
☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ 
Statistics 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ 
Writing 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ ☒ ☐ ☐ ☐ ☐ 
☐ 
Revision 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ ☒ 
☒ 
 
9. Research Estimated Budget in Egyptian Pound  

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
20 
Supplementary 
Publications 
Total 
Material 
Scanning 
Softwares 
 
Tests 
 
Statistics 
 
Others 
(Designing) 
 
International 
publication 
15,000 
5000 
53000 
 
12000 
5000 
- 
10,000 
100000 
 
10. References : 
• Anani, H., Elasser, D., Niazy, M., Jamil, W. and Elsharkawy, D., 2023. 
Evaluation of the remineralization and antibacterial effect of natural versus 
synthetic materials on deep carious dentin: A randomized controlled trial. 
Dental and Medical Problems, 60(1), pp.87–97. 
• Baltacioğlu, İ.H., Demirel, G., Öztürk, B., Aydin, F. and Özcan, M., 2024. 
An evaluation of dental paste-like bulk-fill composite wear using intra-oral 
scanner. Dental Materials Journal, 43(3), pp.446–452. 
• Bronkhorst, H., Bronkhorst, E., Kalaykova, S., van der Meer, W., 
Huysmans, M.C. and Loomans, B., 2022. Precision of in vivo quantitative 
tooth wear measurement using intra-oral scans. Journal of Visualized 
Experiments, (185), p.e63680. doi:10.3791/63680. 
• Dionysopoulos, D. and Gerasimidou, O., 2021. Wear of contemporary 
dental resin composite restorations: a literature review. Restorative 
Dentistry & Endodontics, 46(2), p.e18. doi:10.5395/rde.2021.46.e18. 
• Elderiny, H.M., Khallaf, Y.S., Akah, M.M. and Hassanein, O.E., 2024. 
Clinical evaluation of bioactive injectable resin composite vs conventional 
nanohybrid composite in posterior restorations: An 18-month randomized 
controlled clinical trial. Journal of Contemporary Dental Practice, 25(8), 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
21 
pp.794–802. 
• Elhaddad, E.E.H., Mohsen, M.M.A. and Mohamed, D.E.E., 2024. Clinical 
performance and wear resistance of milled resin composite material versus 
direct nanohybrid bulk-fill resin composite in the restoration of 
endodontically treated posterior teeth over 1 year: Randomized clinical trial. 
Journal of Conservative Dentistry and Endodontics, 27(4), pp.400–407. 
• ElSharouny, F.S.L., Hamza, T. and Ghanem, L., 2025. Digital versus 
conventional methods of wear analysis using two hybrid ceramic materials: 
in-vitro study. Journal of Fundamental and Clinical Research, 5(1), pp.26–
39. 
• Faul, F., Erdfelder, E., Lang, A.G. and Buchner, A., 2007. G*Power 3: A 
flexible statistical power analysis program for the social, behavioral, and 
biomedical sciences. Behavior Research Methods, 39(2), pp.175–191. 
• Ferracane, J.L., 2024. A historical perspective on dental composite 
restorative materials. Journal of Functional Biomaterials, 15, p.173. 
• Garcia, I.M., Balhaddad, A.A., Aljuboori, N., Ibrahim, M.S., Mokeem, L., 
Ogubunka, A., Collares, F.M. and Melo, M.A.S., 2021. Wear behavior and 
surface quality of dental bioactive ions-releasing resins under simulated 
chewing conditions. Frontiers in Oral Health, 2, p.628026. 
• Hirani, R.T., Batra, R. and Kapoor, S., 2018. Comparative evaluation of 
postoperative sensitivity in bulk fill restoratives: A randomized controlled 
trial. Journal of the International Society of Preventive & Community 
Dentistry, 8(6), p.534. 
• Ibrahim, S.A., Niazy, M.A., El-Yasaky, M.A. and El-Kilani, N.S., 2016. 
Effect of nanohydroxyapatite with and without chlorhexidine on 
remineralization of carious dentin at different intervals: An in vivo study. 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
22 
Alexandria Dental Journal, 3, pp.171–176. 
• Ning, K., Bronkhorst, E., Bremers, A., Bronkhorst, H., van der Meer, W., 
Yang, F., Leeuwenburgh, S. and Loomans, B., 2021. Wear behavior of a 
microhybrid composite vs. a nanocomposite in the treatment of severe tooth 
wear patients: A 5-year clinical study. Dental Materials, 37(12), pp.1819–
1827. 
• Pinto, N.S., Jorge, G.R., Vasconcelos, J., Probst, L.F., De-Carli, A.D. and 
Freire, A., 2023. Clinical efficacy of bioactive restorative materials in 
controlling secondary caries: a systematic review and network meta-
analysis. BMC Oral Health, 23. 
• SDI Limited, 2023. Stela: Bulk fill flowable self-cure restorative – Product 
Brochure. 
Victoria, 
Australia: 
SDI 
Limited. 
Available 
at: 
https://www.sdi.com.au [Accessed 7 July 2025]. 
• Urcelay Moreno, N., Bertuol Gessi, S.F., Benabdallah M’Rabat, M., 
Thuissard, I.J. and Santamaria-Laorden, A., 2025. In vivo prospective 
randomised study of the wear of dental restorations using an intraoral 
scanner and its correlation with visual assessment. Journal of Dentistry, 
153, p.105471. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
23 
11. Appendices   
 
Appendix I 
 
 
 
 
Suez Canal University                                                                                                    
Faculty of Dentistry 
Research Ethics Committee (REC) 
-----------------------------------------------------------------------------------------
---------------------------------------- 
Investigator Application Form 
1-Name of researcher: Nada Ismail Mohammed Saleh 
2-Name of Department: conservative dentistry. 
3-Address of researcher: Ismailia, Egypt 
a- Email: nada.saleh@su.edu.eg 
b- Phone number: 01063488822 
4- Names of Co-investigators:  
Prof. Dr. Rehab Elsafy and Dr. Basma Hosny 
5- Grade of protocol: 
*M.D.Sc.  (  )  *Ph.D.  ( )   *Doctorate degree (D.D.Sc.)   ( )  *Other (  ) 
*Domestic (  )            *Multi-Centre within Egypt     (     )      
*International   ( ) 
6- Title of the research:   Clinical Evaluation of Wear 
Resistance and Bioactivity of Self cured Bioactive Resin 
Composite.  
 7-Type of the research: 
*Drug trial (  )    *Surgical technique (     )   *Investigative technique  () 
*Devise study (     ) *Survey study (      )   *Blood sampling  (   ) 
*Review of old records   (     ) 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
24 
 
8-Subjects of research: 
    *Children   (˂ 18 years): (      )    *Adults (>18 years)   ( ) 
 * Vulnerable groups (yes) or (no) 
9-Request is being made to waive (give-up) informed consent:     
Yes: (     )                   No: (   ) 
10- The research is for the good of society: 
 Yes:  (     )                  No:   (     ) 
11-Study design:    
a-Phase type                                                      
 I: (    )                      II:  (      )                   III:  (  )   
b-Randomization:                                                                             
Yes: ( )                  No:  (      ) 
c-Placebo:                                                                                         
Yes: (     )                  No:  (     ) 
d-Genetic sampling:                                                                       
Yes: (  )                  No:  (     ) 
e-Other:                              Yes: (     )                  No:  (     ) 
12-Facilities for the research are available:                                     
Yes: (   )                  No:  (     ) 
13- List the risks of the study:  
No risks have been reported. 
 
14- List the potential benefits, if any, to the subjects : 
The patient will receive the treatment with no fees. 

 
Tel:01063488822 
Fax: 
E-mail:nada.saleh@su.edu.eg 
 
25 
15-Are the risks reasonable to the potential benefits to the subjects, if 
any, or to the knowledge to be gained?     
Yes: ( )                  No: (     ) 
16-Privacy and confidentiality of subjects are assured    
 Yes: (  )                  No: (     ) 
17-The subject of the research could quit at any time without penalty 
or loss of any benefits to which they would otherwise be entitled                         
Yes: (    )                  No:  (     ) 
-----------------------------------------------------------------------------------------
------------------------------------  
Signature of the principal investigator:                                                       
Date: