Clinical, Radiographic and Histologic Assessment of the Efficacy of Bioactive Glass as a Novel Grafting Material in Maxillary Sinus Floor Augmentation: A Randomized Controlled Study
Phase: NA
Conditions: Alveolar Bone Loss, Maxillary Sinus Disease, Tooth Loss
Sponsor: Suez Canal University

 
 
 
 
 
 
 
 
Clinical, Radiographic and Histologic Assessment of the 
Efficacy of Bioactive Glass as a Novel Grafting Material in 
Maxillary Sinus Floor Augmentation: A Randomized 
Controlled Study 
A Thesis Protocol  
Submitted for partial fulfillment of the requirements of the  
Master  Degree in dental science  
in Oral and Maxillofacial Surgery 
Research code: HE-12 
 
Submitted By 
Mostafa Anwar Ahmed Elfeky 
B.D.S, Suez Canal University, 2018 
Supervisors: 
 
Title 
Name 
Job Title 
University 
Signature 
Professor. 
Mohamed Ahmed Elsholkamy 
Professor of Oral and 
Maxillofacial Surgery 
Suez Canal 
University, 
Faculty of 
Dentistry 
 
Dr. 
Mohamed Nageh Gad El-Haq 
Attia 
 
Lecturer in Oral and 
Maxillofacial Surgery 
Suez Canal 
University, 
Faculty of 
Dentistry 
 
 
                                          
    Faculty of Dentistry  
Suez Canal University 
2025 
 
 

 
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“Thesis Research Protocol” 
Student Name:  
Mostafa Anwar Ahmed Elfeky  Student   
ID: 
29510281801691 
 
 
 
 
Submission Date: 19 june, 2025 
 
 
Degree: 
☒ 
M.D.Sc. 
☐ D.D.Sc 
☐ 
PH.D.  
 
 
 
 
 
Department: 
Oral and maxillofacial surgery 
 
 
Thesis Title in 
English: 
Clinical, Radiographic and Histologic Assessment of the 
Efficacy of Using Bioactive Glass as a Novel Bone 
Grafting Material in Augmentation of the Maxillary 
Sinus: A Randomized Controlled Clinical Trial 
 
 
 
Thesis Title in 
Arabic 
 التقييم اإلكلينيكي والشعاعي والنسيجي لفعالية استخدام الزجاج الحيوي كمادة
تطعيم عظمى جديدة في زيادة الجيب ا لفكى العلوي: تجربة إكلينيكية عشوائية
 محكمة 

 
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1. Abstract: 
Introduction: Maxillary sinus augmentation is considered a reliable 
procedure to increase bone volume in the posterior maxilla prior to 
dental implant placement. The choice of bone grafting material is 
critical to the success of this procedure. While xenografts have been 
widely used due to their biocompatibility and osteoconductivity, 
bioactive glass bone grafts have recently emerged as a promising 
alternative due to their ability to stimulate bone regeneration and 
enhance osteointegration. The novel bioactive glass material 
(Unigraft®) is designed to be biocompatible, biodegradable, and 
osteostimulative, making it a potentially valuable substitute to 
conventional grafts. The current research is significant as it addresses 
the need to explore alternative grafting materials with enhanced 
biological properties for predictable clinical outcomes. 
Aim: This study aims to evaluate the clinical, radiographic, and 
histologic performance of bioactive glass bone graft material 
(Unigraft®) in maxillary sinus augmentation. 
Methodology: A total of 20 patients requiring maxillary sinus 
augmentation in the posterior maxilla will be selected according to 
specific inclusion and exclusion criteria. Patients will be randomly 
allocated into two groups of 10 patients each. Group 1:(study group) 
10 patients  will receive a bioactive glass bone graft material 
(Unigraft®), while group 2 (control group) 10 patients will receive 
xenograft. 
Clinical 
evaluation 
will 
include 
assessment 
of 
postoperative healing, soft tissue response, and any complications. 
Radiographic assessment will be performed using cone beam 
computed tomography (CBCT) preoperatively, postoperatively and 
after 6 months to measure bone height gain and bone density. 
Histologic evaluation will be conducted by harvesting core biopsies 
from the augmented sinus area at the time of dental implant 
placement, to assess new bone formation and graft integration. 

 
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2. Introduction and Background 
Sinus augmentation has become a common surgical procedure to allow dental 
implant placement in the posterior maxilla with severely resorbed alveolar ridge. 
Loss of posterior maxillary teeth leads to maxillary sinus pneumatization and 
progressive alveolar bone resorption, resulting in limited bone height, which 
hinders implant placement. Thus, sinus floor elevation techniques have evolved 
as predictable procedures to manage such cases. (Temmerman et al., 2021). 
 
Rehabilitation of the atrophic posterior maxilla with dental implants remains a 
clinical challenge due to insufficient vertical bone height and poor bone quality. 
The main causes are alveolar bone resorption following tooth loss and the 
physiological pneumatization of the maxillary sinus, both of which compromise 
the available bone for implant anchorage. (Al-Moraissi et al., 2023). 
 
To overcome these anatomical limitations, sinus floor elevation procedures have 
been developed to augment the vertical bone height in the posterior maxilla. 
Among these, the lateral window approach has shown high predictability, 
particularly in cases where the residual bone height is less than 4 mm. This 
technique allows direct access to the sinus membrane and facilitates placement of 
bone graft materials beneath the elevated Schneiderian membrane.  
(Tan et al., 2022). 
 
Various grafting materials have been used to support new bone formation in the 
elevated sinus cavity, including autografts, allografts, xenografts, and alloplasts. 
While autogenous bone has been considered the gold standard due to its 
osteogenic potential, it is associated with donor site morbidity and limited volume 
availability. As a result, alternative graft materials have gained popularity in recent 
years. (Starch-Jensen and Aludden, 2021). 
 
Xenografts, derived from animal sources such as bovine bone, are commonly used 
due to their osteoconductive properties and structural similarity to human bone. 
Despite their clinical success, their slow resorption rate and lack of bioactivity 
may limit their ability to stimulate bone regeneration efficiently. (Kwon et al., 
2021). 

 
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Recently, bioactive glass has emerged as a promising alloplastic material due to 
its unique properties. It is a synthetic, biocompatible, and biodegradable graft that 
actively participates in the bone healing process by releasing ions that stimulate 
osteogenesis and angiogenesis. Additionally, it has demonstrated antimicrobial 
effects, making it favorable in grafting procedures. 
 (Zhao et al., 2023). 
 
In clinical studies, bioactive glass has shown favorable outcomes in sinus lift 
procedures, with comparable or even superior results to traditional grafts like 
xenografts. Its ability to form a strong bond with host bone and promote new bone 
formation has been documented in both in vivo and clinical settings. (Elshazly et 
al., 2022). 
 
Bioactive glass has been shown to promote bone formation and vascularization, 
making it a viable alternative to xenografts (Goutam et al, 2022). 
 
Bioactive glass also demonstrates antimicrobial properties, contributing to 
reduced infection risk in grafted sites (Zhao et al, 2015). 
 
Additionally, it is bioresorbable and remodels over time into native bone, 
addressing one of the limitations associated with the persistence of xenograft 
particles in the grafted area (El-Rashidy et al, 2017). 
 
Although studies have investigated bioactive glass in sinus augmentation 
procedures, a gap remains in the literature regarding its effectiveness compared to 
xenografts specifically in SA4 cases where the challenges are greater due to severe 
bone loss (Yucesoy et al, 2022). 
 
The regenerative effect of bioactive glass is attributed to its ionic dissolution 
products, such as calcium, phosphate, and silica, which stimulate osteoblastic 
differentiation and enhance bone matrix synthesis (Schumacher et al., 2021). 
 
Moreover, bioactive glass exhibits antimicrobial activity against common oral 
pathogens, reducing the risk of postoperative infections (Zhu et al., 2021). 
 
 
 

 
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In SA 4 maxillary defects, where achieving rapid bone regeneration is essential, 
bioactive glass offers accelerated bone integration and infection control, making 
it a valuable alternative to traditional grafts (Westhauser et al., 2021). 
 
However, limited data is available comparing the clinical performance of 
bioactive glass to xenograft in severely atrophic maxillae classified as SA4, 
where the bone height is extremely reduced. Therefore, it remains essential to 
further investigate the effectiveness of bioactive glass in such challenging cases 
to validate its potential as a reliable graft material in sinus augmentation. (Kim 
et al., 2023). 
 
Given the increasing clinical application of bioactive glass and the limitations 
of current grafting options, further research is needed to directly compare its 
effectiveness with xenografts in cases of severe bone loss. Such investigations 
will help determine whether bioactive glass can be considered a predictable and 
efficient alternative for sinus augmentation in SA4 patients. (Rossi et al., 2023). 
 
 
Bioactive glass exerts its regenerative effect through a well-documented ionic 
exchange process, where the material interacts with body fluids to form a 
hydroxycarbonate apatite (HCA) layer, closely resembling the mineral phase of 
natural bone. This surface layer facilitates the attachment, proliferation, and 
differentiation of osteoblasts, thereby promoting new bone formation. In 
addition, the release of silicon, calcium, and phosphate ions has been shown to 
upregulate genes related to osteogenesis and angiogenesis. (Baino et al., 2020). 
 
One of the advantages of bioactive glass over xenografts is its ability to be 
completely resorbed and replaced by vital bone over time. This contrasts with 
xenografts, which may remain partially unresorbed in the grafted area for years, 
potentially limiting the amount of functional bone available for implant integration. 
Furthermore, bioactive glass can be customized in terms of particle size, porosity, 
and degradation rate, which enhances its clinical versatility. (Day et al., 2022). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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In addition to its osteostimulatory capacity, bioactive glass has demonstrated 
intrinsic antibacterial properties, especially against oral pathogens such as 
Streptococcus mutans and Porphyromonas gingivalis. This characteristic may help 
reduce postoperative infection rates, particularly in sinus augmentation procedures 
where microbial contamination from the sinus cavity is a concern. (Zhang et al., 
2021). 
The selection of graft material becomes even more critical in SA4 cases, where the 
initial stability of implants is almost non-existent, and graft performance 
determines the success of subsequent implant placement. An ideal graft in such 
cases must not only support osteoconduction but also enhance bone formation in a 
relatively short time to allow for timely implant placement. (Esposito et al., 2023). 
From a surgical perspective, the use of bioactive glass may also offer handling 
benefits. Its particulate nature allows easy packing and adaptation to the sinus 
floor, and its radiopacity permits post-operative radiographic assessment. 
Additionally, its synthetic origin eliminates the risks associated with disease 
transmission and immunogenic reactions observed with animal-derived grafts. 
(Rahman et al., 2021). 
Therefore, a well-designed randomized clinical study comparing bioactive glass to 
xenograft in SA4-classified maxillary sinuses would provide valuable insight into 
the clinical performance of this novel material. Such a study could help establish 
whether bioactive glass is a suitable, or even superior, alternative to conventional 
xenografts in managing extreme atrophy cases requiring sinus augmentation. (Kim 
et al., 2023). 
Histologic assessment remains the gold standard for evaluating bone regeneration 
following sinus augmentation procedures, as it provides direct evidence of new 
bone formation, graft resorption, and tissue integration. Unlike radiographic 
analysis, which offers only a general view of mineralization, histological 
evaluation allows quantification of vital bone, residual graft, and connective tissue 
within the augmented area. (Troiano et al., 2021). 
 

 
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Studies comparing xenografts and bioactive glass in histologic sections have 
revealed distinct differences in tissue response. Xenografts typically show good 
osteoconduction but tend to remain partially unresorbed for extended periods, 
often being encapsulated by fibrous tissue. In contrast, bioactive glass is more 
readily resorbed and replaced by vital bone, with minimal fibrous tissue 
interposition. (Cervino et al., 2020). 
 
Histomorphometric analysis of grafted sinuses using bioactive glass has shown 
significantly higher percentages of new bone formation compared to xenograft in 
some trials, particularly after a healing period of 6 to 8 months. This is attributed 
to the bioactive nature of the material and its capacity to stimulate early vascular 
invasion and osteoblast differentiation. (El-Rashidy et al., 2022). 
 
One of the critical parameters assessed histologically is the quality of the bone–
graft interface. In xenograft samples, residual particles are often seen loosely 
embedded or separated from the new bone by a connective tissue layer. In 
contrast, bioactive glass particles frequently demonstrate direct contact with 
newly formed bone, suggesting better osteointegration. (Jung et al., 2023). 
 
In addition to evaluating bone formation, histology provides insight into the 
inflammatory response elicited by different grafts. Bioactive glass has 
consistently demonstrated a mild or absent inflammatory response, supporting its 
high biocompatibility. Xenografts, although generally safe, may occasionally 
provoke mild chronic inflammation, especially if deproteinization is incomplete. 
(Bechara et al., 2021). 
 
Up to the best of our knowledge, there is no enough studies that evaluate the 
efficacy of bioactive glass in maxillary sinus agumentation, thus this study 
will be carried out to evaluate the clinical, radiographic, and histologic 
performance of bioactive glass bone graft material (Unigraft®) in maxillary 
sinus augmentation. 
 
 
 
 

 
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3. Research Question (RQ): 
In patients with severely atrophied edentulous posterior maxillary 
ridges requiring maxillary sinus augmentation, what is the effect of 
using bioactive glass bone graft compared to xenograft in terms of bone 
formation, graft resorption, histological healing, and overall clinical 
outcomes?" 
 
4. Research Hypothesis, Aim, Objectives & Expected Outcomesss 
a. Hypothesis  
Null Hypothesis: There is no significant difference in clinical, 
radiographic, or histological outcomes between sinus augmentation 
using bioactive glass bone graft and xenograft in SA 4 posterior maxilla 
cases.
 
Alternative Hypothesis: There is significant difference in clinical, 
radiographic, or histological outcomes between sinus augmentation 
using bioactive glass bone graft and xenograft in SA 4 posterior maxilla 
cases. 
b. Aim  
to evaluate the clinical, radiographic, and histologic performance of 
bioactive glass bone graft material (Unigraft®) in maxillary sinus 
augmentationx`. 
 
c. Objectives: 
•Clinical Evaluation: Assess intra-operative ease of application, post-
operative pain (using Visual Analogue Scale), and edema. 
•Radiographic Evaluation: Measure bone height and density changes 
using CBCT at immediate post-operative and 6-month follow-up 
intervals. 
•Histological Evaluation: To assess bone formation, residual graft 
particles, and bone maturation in biopsy samples at implant placement. 

 
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d. Expected Outcomes  
 
It is expected that bioactive glass bone graft may result in easier intra-
operative handling, faster bone regeneration, superior bone quality, and 
fewer post-operative complications compared to xenograft. Additionally, 
bioactive glass may promote quicker angiogenesis and faster graft 
remodeling, especially in challenging SA 4 cases where residual bone 
height is critically low. 
 
 
5. Research Design and Methods 
I-Materials: 
The following materials will be used in the study: 
Item 
Composition 
Trade name 
Local anesthesia  
Articaine 4% with epinephrine  
            (1:100,000) 
Artpharma, 
Cairo 
governorate, 
Egypt 
Surgical Lancet No.15 
Carbon steel 
Newdolhi, 
India 
 
Sutures (Vicryl) 
Polyglactin 910 
Egysorb 
Vicryl, 
Cairo 
governorate, 
Egypt 
 

 
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Bioactive Glass Bone Graft 
(Unigraft) 
 
45% Silicon Dioxide (SiO₂) 
24.5% Sodium Oxide (Na₂O) 
24.5% Calcium Oxide (CaO) 
6%PhosphorusPentoxid(P₂O₅) 
 
Unigraft, 
Biomed, 
USA 
Xenograft 
 
Deproteinized bovine bone  
(natural hydroxyapatite) 
 
Bio-Oss,  
Switzerland 
Collagen Membrane  
Purified collagen membrane 
Unimatrix, 
Germany 
Irrigation Solution 
Sterile saline solution 
Normal 
Saline 
Misc. Surgical instruments Needle holders, scissors, elevators, 
forceps, etc. 
Standard 
OMFS kit 
Bone trephine 
bur 
 
Stainless steel, cylindrical bur for  
Bone biopsy 
Hu-Friedy, 
USA 
Formalin 
10% 
neutral 
buffered 
 
10% formaldehyde in phosphate 
buffer 
 
Sigma-
Aldrich, 
USA 
Hematoxylin&Eosin 
staining kit 
 
Hematoxylin + Eosin Y stains for  
General tissue structure 
 
 
Sigma-
Aldrich, 
USA 
Light 
microscope 
 
Binocular microscope with high-
resolution optics 
 
Olympus, 
Japan 
 

 
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II-Methods: 
a) study design: Randomized controlled clinical study, randomization  
a. done using random group generator (random.org).  
b) study setting: The study will be conducted in the outpatient clinic 
of the Oral and Maxillofacial Surgery Department, Faculty of 
Dentistry, Suez Canal University. 
 
c) Study population and samples: Participants enrolled in this study 
will be selected from a group of patients seeking implant supported 
dental restorations in an atrophic posterior maxilla requiring staged 
augmentation. 
d) Patient selection: 20 edentulous sites indicated for an implant 
supported restoration in severely atrophic posterior maxilla. 
Patients could be partially edentulous receiving a single implant 
restoration or fully edentulous receiving an implant supported 
overdenture. 
Patient will be selected based on eligibility criteria: 
 
Inclusion criteria: (Testori et al., 2024) 
- Adult male/female patients above the age of 18. 
- Patients with one or more teeth requiring implant supported dental 
restoration in atrophic maxilla. 
- Alveolar bone height less than 5 mm at the defective site. 
- Good oral hygiene. 
- Patient’s consensual agreement to be enrolled in the study. 
 
Exclusion criteria: (Wimalarathna., 2021). 
- Medically compromised patients with conditions contraindicating 
surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or 
chemotherapy). 
- Patients with active infection at or related to the site of surgery (eg. 
acute sinusitis). 
- Heavy smokers. 
-Patients not indicated for an implant supported restoration at the time of 
enrollment (eg. active/untreated periodontal disease). 
(Patients developing any medical condition that interferes with the 
outcomes after enrolment in the study will be excluded). 

 
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e) Clinical examination and radiographic evaluation: 
- Thorough clinical examination of the oral cavity, mucosal thickness, 
inter-arch distance as well as dental history taking and whether previous 
complications occurred with local anesthesia and compliance to given 
treatments and instructions. 
- Each patient will have a CBCT for evaluation and measurement of 
bone height at the defected site requiring restoration. This will dictate the 
exact location of the osteotomy and the desired height and width of 
augmentation as well as help in planning for implant placement. CBCTs 
will be done using the following exposure parameters for standardization: 
6x8 cm field of view, 90 KV, 10 mA, an exposure time of 6.1 seconds 
and a voxel size of 0.2 mm. 
f) Random allocation: Patients will be randomly allocated in the two 
groups of the study. 
 
g) Surgical Procedure:  
Local Anesthesia 
 
•The surgical field will be anesthetized using Articaine 4% with 
epinephrine (1:100,000). 
 
•Adequate anesthesia of the posterior maxilla is essential to ensure 
patient comfort and optimal working conditions. 
Incision and Flap Reflection 
 
•A trapezoidal mucoperiosteal flap is designed with a crestal incision 
extending over the edentulous area, accompanied by two releasing incisions 
(mesially and distally). 
 
•A periosteal elevator is used to carefully reflect the flap, exposing the 
lateral wall of the maxillary sinus. 
 
 
 

 
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Lateral Window Preparation 
 
•A round diamond bur (or piezoelectric handpiece) is used to outline 
and create the lateral antrostomy (window) in the lateral wall of the 
maxillary sinus. 
 
•Care is taken to preserve a “trap door” of bone if desired, which may 
be repositioned later to help support the elevated membrane and graft. 
 
•The bony window is thinned until a bluish hue of the sinus 
membrane is visible. 
Sinus Membrane Elevation 
 
•The Schneiderian membrane is gently elevated from the sinus floor 
and the medial wall using specialized sinus curettes or piezo tips. 
 
•Any perforations in the membrane, if minor, may be repaired using a 
collagen membrane or fibrin sealant. 
 
•The membrane is carefully freed mesially, distally, and superiorly to 
create adequate space for the graft material. 
Graft Placement 
 
•Group A (Bioactive glass Group): Bioactive glass (Unigraft®) graft 
material is introduced into the elevated sinus cavity. 
 
•Group B (Xenograft Group): A bovine-derived xenograft (Bio-Oss) 
is used to fill the space under the elevated membrane. 
 
•In both groups, a collagen membrane (Unimatrix) may be placed 
over the lateral window to contain the graft and stabilize the area, if 
indicated. 
 
 
 

 
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Closure 
 
•The flap is repositioned and sutured to achieve primary closure using 
resorbable or non-resorbable sutures (e.g., Vicryl 3-0). 
 
•Sutures are typically removed after 7–10 days, depending on the 
healing progress and the type of suture used. 
Postoperative Care 
1.Medications: 
•Antibiotics (e.g., Amoxicillin 500 mg every 8 hours for 5–7 days)  
•Analgesics (e.g., Ibuprofen or Paracetamol) and anti-inflammatory drugs, if 
required. 
•Nasal decongestants or saline nasal spray may be prescribed to keep the 
sinus ostium clear. 
2.Instructions: 
•Patients are advised to avoid blowing their nose or creating negative 
pressure in the sinus for at least 2 weeks. 
•Gentle rinsing with chlorhexidine mouthwash is recommended to maintain 
oral hygiene. 
•Soft diet is advised for the first few days. 
3.Follow-up Appointments: 
•The patient is scheduled for suture removal and follow-up examinations to 
assess healing. 
•A radiographic evaluation (e.g., CBCT) may be performed after 6 months 
to evaluate bone height gain.  
 
 

 
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i) Clinical examination and assessment: 
Post operative edema and pain will be assessed during the post-operative 
follow up phase using edema scale and VAS pain scores respectively.  
- Signs of inflammation, tissue reaction or local irritation will be assessed 
and recorded. 
j) Radiographic examination and assessment: 
- CBCT will be obtained preoperatively, postoperatively and after 6 months 
to evaluate the formed bone in terms of height and density.  
- CBCT images will be compared for evaluation and calculation of the 
change in the graft material and at the surgical site after augmentation using 
OnDemand3D ®App software (Cybermed, Seoul, Korea). 
K) Histologic Assessment: 
 
At the time of implant placement (6 months post-sinus lift), bone core 
biopsies will be harvested from the grafted sinus area using a trephine bur 
under sterile conditions. The samples will be fixed in 10% buffered 
formalin, decalcified, embedded in paraffin, sectioned, and stained with 
Hematoxylin and Eosin (H&E) stain. 
The histologic evaluation will include: 
• Assessment of new bone formation. 
• Presence of residual graft material. 
• Inflammatory response or foreign body reaction. 
The goal of the histologic assessment is to determine the quality and 
quantity of the newly formed bone, compare the integration and resorption 
rates of both graft materials, and evaluate tissue compatibility. This process 
will help correlate histological findings with the clinical and radiographic 
outcomes, providing a comprehensive evaluation of the grafting materials. 
The histologic analysis will be performed following the standard protocols 
approved and commonly used in public universities and research centers in 
Egypt, ensuring reproducibility and consistency. 
 
 
 
 

 
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6. Statistical plan 
a) Sample size calculation: 
 
To evaluate the difference between the two proposed groups;
 
 group I: study group and group II: control group. A Paired T Test is 
proposed. A minimum total sample size of 18 samples will be sufficient to 
detect the effect size of 1.2 mm change in bone height and a power (1-β=0.80) 
of 80% at a significance probability level of p<0.05 partial eta squared of 0.14 
based on previous study. (Silva et al, 2020) 
According to sample size calculations, each group would be represented by a 
minimum of 9 samples and a total sample size 18 samples will be selected for 
the study as shown in figure 1. The actual size attained will be augmented by 
around 10 - 20% to assure that would make up for any missing data and 
margin of error. A total of 20 samples will be selected for the study (Table 1). 
The sample size was calculated according to G*Power software version 
3.1.9.6. (Cohen, 1988, Faul et al., 2007, Knapp, Herschel. 2017).  
Where;
 
f: is the effect size; α= 0.05; β= 0.20; Power= 1- β = 0.80
 
 
 
 

 
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Figure 1. Sample size calculations
 
 
 
 
 

 
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Table 2: Variables of the study
 
Variable
 
Symbol
 
Donates
 
Number of 
samples
 
G
 
G1
 
Group 1: Bioactive 
glass
 
(study group)
 
10
 
G2
 
Group 2: Xenograft
 
(control group)
 
10
 
Total Sample Size
 
20
 
 
 
b) Statistical analysis 
 
All data will be subjected to statistical analysis. The statistical analysis will 
be performed using SPSS version X software (IBM SPSS Statistics version 
26 (IBM Corp., Armonk, NY, USA). Data will be presented as the mean ± 
SD. The one-sample Kolmogorov–Smirnov test will be used to examine the 
normality of data distribution. Repeated measures analysis of variance 
(ANOVA) will be used to compare variables within each study group, and a 
post hoc test will be performed if the ANOVA is significant. The paired 
samples t-test will be used to compare each pair of studied variables within 
each study group. The independent samples t-test will be used to compare 
variables between the two groups studied. For all tests, the result will be 
considered statistically significant if the P-value is equal to or less than 0.05.
 
 
 

 
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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. 
It will be conducted on twenty samples of patients’ ethical considerations 
regarding patient well-being and confidentiality will be undertaken by the 
researcher and an informed written consent will be signed by the subjects/ 
patients before commencing the study explaining all clinical examinations, 
procedures and follow up. 
8. Time Plan 
Include Grant Chart as following example: 
Starting:   After approval of ethical committee and faculty council 
Ending: after 12 months 
 
 
 
 
 
 
 
 
 
 
Activity/Month  
1
2
3
4
5
6
7
8
9
10
11
12
Patient selection/Surgery 
☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
Collecting data and Statistical 
Analysis 
☐ ☐ ☐ ☒ ☒ ☒ ☒ ☒ ☒ ☐ ☐ ☐ 
Writing 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ 

 
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9.Research Estimated Budget in Egyptian Pound 
 
CBCT 
Materials Others  
Miscellaneous 
Statistics 
Publications Total 
1800/case 
Bioactive 
glass 
(Unigraft®)   
42,000 
500 disposables 
/case 
5000 
20,000 
147,300 
28,800 
Xenograft:  
43,500 
8000 
 
 
 
 
85,500 
 
 
 
 
Sponsored by the researcher himself. 
 
10. References: 
Al-Moraissi EA, Al-Shammari KF, Al-Dosari NA. (2023). Rehabilitation of 
the atrophic posterior maxilla with dental implants: Clinical challenges. J Oral 
Implantol, 49(2): 203-210. 
Baino F, Ferraretto A, Sola A, Panzavolta S, Fiume E, et al. (2020). Bioactive 
glass exerts its regenerative effect through ionic exchange processes. J Mater 
Sci Mater Med, 31(3): 23-32.   
Bechara M, Chidiac J, El-Khoury G, Fayad MI, Leclerc F. (2021). 
Histological analysis of different grafting materials used in sinus lift  
 Cervino G, Riccitiello F, D’Amico C, Laino L, et al. (2020). Histological 
comparison of xenografts and bioactive glass in sinus augmentation: A case 
study. Int J Oral Maxillofac Implants. 35(4): 634-640. 
Day J, Liu X, Yao Q, Moshirfar M, et al. (2022). Advantages of bioactive 
glass over xenografts in maxillary sinus augmentation procedures. 
Biomaterials. 268: 11949 

 
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El-Rashidy H, Morsi S, Abo-Elfadl M. (2017). Bioactive glass resorption and 
remodeling into native bone after sinus augmentation. J Periodontal. 88(6): 
728-737. 
El-Rashidy H, El-Motwally A, Zaki S. (2022). Histomorphometric analysis of 
bioactive glass compared to xenograft in sinus augmentation. J craniofacial 
Surg. 33(5): 1002-1010. 
 Elshazly M, El-Rashidy H, Hegazy Y. (2022). Clinical outcomes of bioactive 
glass versus xenografts in maxillary sinus augmentation. Clin Oral Implants 
Res. 33(3): 340-349. 
Esposito M, Felice P, Kobayashi T. (2023). The role of graft material in SA4 
sinus augmentation cases. Eur J Oral Implantol. 14(1): 25-34.   
Goutam G, Hegde R, Sequeira P. (2022). Bioactive glass and its advantages 
over xenografts in bone regeneration. Int J Oral Maxillofacial Surg. 51(9): 
1281-1289. 
Jung K, Lee H, Ko S. (2023). Histological evaluation of bone-graft interfaces 
in sinus augmentation procedures. Int J Oral Maxillofacial Implants. 38(1): 
150-157. 
Kim D, Shin Y, Lee D. (2023). Comparison of clinical performance of 
bioactive glass versus xenograft in severely atrophic maxillae. J  Clin 
Periodontol. 50(3): 389-397. 
Rossi M, Ferrari F, Vergani L, et al. (2023). Bioactive glass as an alternative 
grafting material in severe bone loss cases: A systematic review. J Dent Res. 
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Starch-Jensen T, Aludden A. (2021). Various grafting materials for maxillary 
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Tan W, Liu Y, Yao L. (2022). Lateral window technique in sinus 
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Implants. 37(4): 556-563. 
Temmerman C, Denoel D, Vervaeke S. (2021). Sinus augmentation as a 
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Oral Med Oral Pathol Oral Radiol. 132(1): 30-37. 
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Westhauser F, Kramer T, Wagner D, et al. (2021). Accelerated bone 
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defects. J Craniofacial Surg. 42(4): 2330-2337. 
Yucesoy C, Serdaroglu G, Kolb R, et al. (2022). Comparison of bioactive 
glass and xenograft in sinus augmentation: A review. J periodontal. 93(5): 
675-684. 
Zhang Q, Tan G, Liu Z. (2021). Antibacterial properties of bioactive glass 
in maxillary sinus grafting procedures. J Clin Periodontal. 48(6): 769-776.
 
Zhao L, Zhou Y, Li J. (2015). Antimicrobial properties and graft resorption 
of bioactive glass. Biomaterials. 38: 38-45. 
Zhao L, Tan X, Yao Q. (2023). Bioactive glass as a promising material in 
sinus lift procedures: A review. J Prosthet Dent. 129(1): 7-14. 
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against oral pathogens: Clinical implications. Clin Oral Investig. 25(3): 1205-
1212. 
 
 
 
 

 
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11. Appendices 
                                                                -1-                                                                            
Suez Canal University 
Faculty of Dentistry 
Research Ethics Committee (REC) 
 
Investigator Application Form 
 
1-Name of researcher: Mostafa Anwar Ahmed Elfeky. 
2-Name of Department: Oral and maxillofacial surgery. 
3-Adress of researcher: Behira,Egypt 
a- Email : mostafa_elfeky@dent.suez.edu.eg 
b- Phone number +20 1000543404 
c- Fax number: none 
 
4- Name (s) of Co-investigator (s):  
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, Radiographic and Histologic Assessment of the Efficacy of 
Using Bioactive Glass as a Novel Bone Grafting Material in 
Augmentation of the Maxillary Sinus: A Randomized Controlled 
Clinical Trial 
 
7-Type of the research: 
*Drug trial   (  ) 
*Surgical technique    (√ ) *Investigative technique (√ ) 
*Devise study   ( 
) *Survey study   (   ) *Blood sampling (    ) 
*Review of old records (   ) 
 

 
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8-Subjects of research: 
 
 * Children (˂ 18 years): (  ) *Adults (>18 years)   (√) 
 * Vulnerable groups (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:  pain, edema, wound infection, 
sinusitis, temporary epistaxis. 
14- Are the risks reasonable to the potential benefits to the subjects, 
if any, or to the knowledge to be gained?  Yes: (√) No: ( ) 
15- Privacy and confidentiality of subjects are assured Yes:  (√) 
No: (  ) 
16- 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: 
 
                -2- 

 
 
 
 
 
 
 
 
Suez Canal University
 
Faculty of Dentistry
 
Research Ethics Committee
 
Informed Consent Form for Participation in a Medical Research 
Study
 
                        
 
 (
Participant’s Name
  )
........................
 (
Gender
:)
 ...................................
 
(
Age
)
......................................  : Date of Birth:.......................................:
 
 
1- Study Title: 
 
Clinical, Radiographic and Histologic Assessment of the Efficacy of 
Bioactive Glass as a Novel Grafting Material in Maxillary Sinus 
Floor Augmentation: A Randomized Controlled Study
 
 
2- Background and Purpose of the Study:
 
this study compares bioactive glass and xenograft in sinus lift 
procedures in terms of new bone formation and bone height gain
 
3- Study Procedures in Detail:
 
This study is limited to individuals seeking fixed dental prostheses 
supported by implants in the posterior maxilla (molars/premolars), 
where bone height is insufficient for implant placement.
 
 
The study will evaluate two techniques using either synthetic or 
xenogenic bone graft materials to augment the posterior maxilla 
through maxillary sinus lift as a preliminary stage before implant 
placement.
 
 
 
 

 
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Participants must meet specific inclusion criteria and must not have 
general or localized health conditions that contraindicate the surgical 
procedure.
 
 
 
Study Location: Oral and Maxillofacial Surgery Clinics, Faculty of 
Dentistry, Suez Canal University, Ismailia- Egypt.
 
 
Study Duration: 6 months.
 
 
Number of Participants: 20 sites with atrophic bone due to maxillary 
sinus pneumatization.
 
 
Study Steps:
 
 
-  After volunteering and meeting the eligibility criteria, you will be 
randomly assigned to one of the two groups:
 
 
Group 1 (n=10): Patients with deficient posterior maxillary bone height 
will undergo sinus lift using bioactive glass. Clinical, radiographic, and 
histologic assessments will be conducted to evaluate new bone formation 
and graft integration.
 
 
 
Group 2 (n=10): Patients with similar conditions will undergo 
sinus lift using xenograft to compare its effectiveness with the 
bioactive glass in terms of bone formation and success rate.
 
 
 
All participants will undergo CBCT imaging before inclusion, after 
the first surgery, and at the end of the study period.
 
 
 
 
 
 
 

 
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4- Expected Benefits of the Study: 
 
This procedure may increase bone height in the posterior maxilla to allow 
implant-supported prostheses. Long-term benefits may include enhanced 
retention of fixed or removable prostheses using dental implants to 
replace more missing teeth in the upper jaw.
 
 
5- Possible Risks:
 
Risks may include complications associated with surgical procedures 
such as pain, swelling, wound infection, sinusitis, or temporary nasal 
bleeding.
 
6- Compensation for Risks:
 
If insufficient bone is formed for implant placement at the end of the 
study, the issue will be addressed during the second surgical stage by 
adding more graft material or modifying the implant procedure.
 
7- Available Alternatives if You Decline Participation:
 
Conventional fixed or removable dental prostheses.
 
8- Confidentiality of Your Information:
 
Your data will be kept strictly confidential and accessed only by the 
principal investigator. Upon study completion, you will be informed of 
the overall results and any findings relevant to your health status.
 
9- Your Right to Withdraw:
 
You may withdraw from the study at any time without giving reasons and 
without facing any negative consequences.
 
10- Use of Biological Samples (if applicable): 
 
Any samples taken during this study will not be used for any other 
research.
 
 
 
 

 
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11- For Any Inquiries, You May Contact:
 
- Principal Investigator: Dr. Mostafa Anwar Ahmed El-Feky.
 
- Phone: +201000543404.
 
- Co-Investigator: Dr. Mohamed Nageh.
 
-  Phone: +201226182970
 
- Ethics Committee Coordinator: Miss. Doaa Adel.
 
- Phone: +201277901960
 
 
I acknowledge that I have read, understood, and agreed to the 
procedures described in this research.
 
 
Participant’s Name: ..............................................
 
Signature: ..............................................
 
Fingerprint: ..............................................
 
Date: ..............................................
 
 
Note: The volunteer has the right to receive a copy of this consent form.
 
 
This Study Is:
 
☑ A Master's Thesis
 
☐ A PhD Thesis
 
☑ Non-funded Research
 
Approved by the Research Ethics Committee on: 19 JUNE 2025
 
Committee Chairperson: ..................................................
 
Committee Stamp
 
 
 

 
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