Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
Phase: NA
Conditions: Space Maintenance, 3D Printing, Primary Teeth
Sponsor: British University In Egypt

 
 
 
 
 
 
 
 
Evaluation of a Novel 3D Printed Space Maintainer Versus the 
Conventional Stainless-Steel Band and Loop:  A Finite Element 
Analysis and in-Vivo Study 
A Thesis Protocol 
Submitted to the Faculty of Dentistry, Suez Canal University 
for partial fulfillment of the requirements of the Doctorate Degree of 
Dental Science in Pediatric Dentistry 
Research code: HR1 
Submitted By : 
Omar Assem Hanafi Hussein Hodhod 
B.D.s, Ainshams University (2011), 
M.D.Sc. of Pediatric Dentistry, Ainshams University (2021), 
Assistant lecturer in Pediatric Dentistry Department, British University in Egypt. 
Supervisors: 
Title 
Name 
Job Title 
University Signature 
Dr. Mohammed Sherif 
Mohammed Salah 
El Din Hassan 
Farag 
Professor of Pediatric 
Dentistry, Preventive 
Dentistry, and Dental 
Public Health. 
Suez Canal 
University 
 
 Dr. 
Shaimaa 
Mohammed 
Mahfouz Omer 
Associate Professor 
of Pediatric Dentistry, 
Preventive Dentistry, 
and Dental Public 
Health. 
Suez Canal 
University 
 
Dr. 
Yousra Samir 
Mohammed Helmy 
Lecturer of 
Pediatric Dentistry, 
Preventive Dentistry, 
and Dental Public 
Health. 
Suez Canal 
University 
 
Dr.  Islam Tarek Abbas 
Hassan 
Professor of 
Orthodontics 
The British 
University 
in Egypt 
 
 
Faculty of Dentistry 
Suez Canal University 
Approval Date 16 May 2023 

 
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Faculty of Dentistry 
“Thesis Research Protocol” 
 
Student 
Name: 
Omar Assem Hanafi Hussein 
Hodhod 
Student 
ID: 
29002070101736 
 
 
 
 
Submission 
Date: 
3/2/2023 
 
 
Degree: 
☐M.D.Sc. 
☒   D.D.Sc. 
☐ 
 
  Ph.D. 
 
 
 
  
Department: Pediatric Dentistry, Preventive Dentistry, and Dental 
Public Health. 
 
 
Thesis Title 
in English: 
Evaluation of a Novel 3D printed Space Maintainer 
Versus the Conventional Stainless-Steel Band and 
Loop:  A Finite Element Analysis and in-Vivo Study. 
 
 
 

 
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1. Abstract 
Introduction: Space maintenance is recommended in most cases after 
primary molar loss to avoid or decrease malocclusions in the future; the 
current gold standard for single deciduous molar loss is the metal Band 
and loop. Among their disadvantages are bad aesthetics, gingival 
impingement, and rotation or tilting of abutment teeth; to improve on 
these faults and decrease lab time and impression discomfort, an optical 
impression will be taken, and a novel 3D printed space maintainer with 
a novel design will be tested. 
 
Aim: This study evaluates the simulated and clinical performance of a 
new 3D-printed material versus the metal band and loop. 
 
Methodology: The study will consist of two stages. 
The first stage will be a finite element analysis using two different 3D 
printing resins to discover which 3D printing resin has superior 
properties and validate the novel design for a single tooth space 
maintainer. 
The second stage will be a split-mouth Randomized Controlled trial 
using a 3D Printed Resin space maintainer versus the conventional Band 
& Loop. The study will be held on 26 newly extracted primary molar 
single tooth areas in 13 patients over twelve months.  
This study will measure clinical success/failure, space loss, rotations, 
gingival and plaque index, and patient pain and satisfaction. 
 

 
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2. Introduction and Background 
The primary dentition significantly influences the child's growth, 
occlusal relationships, and dentofacial structures (Bhujel et al., 
2016). Early deciduous tooth loss brought on by caries, trauma, 
ectopic eruption, and other factors can result in undesired primary or 
permanent tooth movements where arch length is reduced (Shalan 
and Abo Bakr, 2018). Deficient arch length may result in crowding, 
rotations, ectopic eruption, crossbite, excessive overjet, excessive 
overbite, and unfavorable molar relationships. In addition, this arch-
length deficiency may cause malocclusions or worsen existing 
malocclusion (Özüdoğru and Tosun, 2021). 
 
The most efficient technique to stop future malocclusion due to tooth 
loss is to install a space maintainer that is efficient, long-lasting, and 
affordable (Watt et al., 2018). The optimal space maintainer depends 
on the child's stage of dental development, dental arch, associated 
missing teeth, occlusion, patient's age, and capacity to comply with 
and tolerate an appliance (Ramakrishnan et al., 2019). 
 
The classic stainless-steel band & Loop space maintainer is the most 
common fixed space maintainer for single tooth loss(Watt et al., 
2018). The BL space maintainer is affordable, requires little chair 
time, and is easily adaptable to changing dentition (Khanna et al., 
2015). 

 
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However, because of the laboratory work, manufacturing metal BL 
consumes time. Other drawbacks include wedging into gingival 
tissues, cement deterioration, inadequate aesthetic quality, and 
inability to stop the rotation and tilting of abutment teeth (Dhanotra 
and Bhatia, 2021). 
 
Due to these drawbacks and the growing popularity of cosmetic 
dentistry, innovative materials, and designs for space maintainers 
were developed, which include fiber-reinforced composite, directly 
bonded, and prefabricated space maintainers. (Mittal et al., 2018). 
 
The most popular form of additive manufacturing 3D Printing finds 
new uses in dentistry daily; it can generate a tangible item of almost 
any shape based on a digital 3D model (Methani et al., 2020). This 
technology uses a variety of machines and biocompatible materials 
(Vasamsetty et al., 2019). 
 
The introduction of Digital additive (3D Printing) and subtractive 
manufacturing (CAD/CAM) in dentistry has raised the bar for finding 
a replacement for the shortcomings of the metal band and loop space 
maintainers today. In addition, different novel materials and uses are 
being discovered as digital manufacturing is more accessible to 
dentists (Rekow, 2020). 
 
Numerous dental institutions and laboratories now have different 3D 
printing technology systems available. Due to its technological 

 
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benefits in precision, speed, and quality, it is becoming an alternative 
to famous traditional treatment options (Methani et al., 2020). 
 
The ability to create accurate custom appliances without needing 
impression taking or laboratory work is a benefit of adopting 3D 
scanning and Printing to create space maintainers. In addition to 
saving cost and time, printing the appliance as a mono-block reduces 
the likelihood of breakage, which lowers the risk of appliance failure 
(Muta et al., 2020). 
 
Numerous 3D printing techniques are used in the dental field, such as 
stereolithography (SLA), digital light projection (DLP), polyjet or 
multijet, inkjet printing, fused deposition modeling (FDM), and 
powder bed fusion. The differentiating factor between these 
techniques is the materials used and how the layers are deposited to 
generate the 3D object (Oberoi et al., 2018). 
 
Many materials are available for 3D Printing, such as polymers, 
metals, ceramics, and composites .
  Polymers represent the most 
common 3D printing material used by dental 3D printers out of all the  
alternatives .
  These polymers come in various shapes, including 
filament, powder, and resin (Javaid and Haleem, 2019). 
 
Band and loop space maintainer made via 3D Printing has the 
advantages of reducing human error, lengthy laboratory procedures, 
and chair side time. 

 
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However, there needs to be more clinical proof that these new, novel 
SMs are more effective than their traditional counterparts (Khanna et 
al., 2021). 
 
Since  the 3D-Printed resin materials used for orthodontic splints, 
Crowns, and bridges were tested in numerous studies before(Prpic et 
al., 2019; Shin et al., 2020; Wang et al., 2019), while no study up till 
now clinically evaluates a resin 3D-printed space maintainer, so this 
study aims to evaluate the simulated and clinical performance of a 
resin 3D-printed space maintainer versus the conventional band and 
loop space maintainer. 
 
 
 
 

 
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3. Research Question: 
How does the novel resin 3D printed space maintainer perform in Finite 
element analysis and its clinical success compared to the conventional 
Band & Loop space maintainer? 
 
 
4. Research Hypothesis, Aim, Objectives & Expected 
Outcomes 
a. Hypothesis 
Null Hypothesis: 
There is no significant difference in Finite element analysis or clinically 
between the resin 3D printed space maintainer and the conventional 
Band and Loop. 
 
Alternative Hypothesis: 
The resin 3D printed space maintainer shows a significant difference in 
Finite element analysis and clinical success than the conventional Band 
and Loop. 
 
 
 
b. Aim 
This study aims to evaluate the simulated and clinical performance 
of a resin 3D-printed space maintainer versus the conventional band and 
loop space maintainer. 
 
 
 

 
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c. Objectives 
This study aims to evaluate the simulated and clinical performance of a 
resin 3D-printed space maintainer versus the conventional band and loop 
space maintainer though these two stages : 
 
1. Finite Element Analysis (simulated performance) 
The final choice of design and materials for the clinical tests will be 
chosen after finding the most success in the following tests: 
i. 
Maximum stress before plastic deformation. 
ii. 
Fracture resistance. 
iii. 
Stress distribution. 
iv. 
Mechanical behavior and cyclic fatigue resistance. 
v. 
Moment or rotation of the device 
 
2. An In Vivo Analysis 
Clinical comparison using the optimal design and material for resin 3D 
printed Space maintainer decided by the Finite Element Analysis vs. 
conventional Band and loop with one year of follow-up. 
Evaluated bypass or Fail: 
i. Cement loss / Debonding. 
ii. Fracture of the space maintainer. 
iii. Caries of abutment teeth. 
Measured outcomes: 
iv. Gingival index of abutment teeth. 
v. Plaque index of abutment teeth. 
vi. Space Change measured by software. 

 
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vii. Rotation of abutment teeth measured by software. 
viii. Wong-Baker Faces Scale to check: Patient pain experience,  patient 
satisfaction, and mastication experience. 
 
 
 
 
d. Expected Outcomes 
For the simulated test: 
Finite element analysis will show that the novel design and 3D printing 
resin which are suitable for use as a single tooth space maintainer. 
 
For the clinical tests: 
One-year clinical follow-up will show that the novel design of the resin 
3D printed resin has a success rate comparable to or better than the 
conventional band and loop space maintainer concluding if it is suitable 
for use as a single tooth space maintainer. 
 
 
 

 
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5. Research Design and Methods 
I. Materials 
Materials used in this study are in table 1. 
Table (1):tradename , composition and Manufacturers  
Trade name 
Material composition 
Manufacturer 
Ortho-rigid 
C&B MFH 
Monomer based on acrylic 
esters 3D printing material 
Vertex-Dental B.V., 
Netherlands  
G-CEM™ Capsule 
Self-Adhesive Luting 
Cement in Capsules 
Resin Cement 
G.C. Corporation, Tokyo, 
Japan 
Cavex Cream Alginate 
Alginate material 
Cavex, Holland. 
Molar bands 
Ready-made molar Bands 
American Orthodontics. 
Washington Avenue, 
USA 
Loop 
A 0.9 mm (0.036 inches) 
stainless steel wire 
 
Rapidshaper 3D printer 
 
Resin 3D printer 
Vertex-Dental B.V., 
Netherlands 
TRIOS®3, 3Shape 
intraoral scanner 
Intraoral scanner 
3shape, Copenhagen, 
Denmark 
Pedo jaw model 6-year-
old dentition 
Soft Gingiva Jaw Model 
NISSIN DENTAL 
PRODUCTS INC. Kyoto 
601-8469 JAPAN 
 
 
 
 

 
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II. Methods 
II.1.Study setting 
This 
study 
will 
be 
composed 
of 
2 
different 
stages: 
Stage I: an in vitro 3D finite element analysis study. 
A Finite element analysis simulating the mechanical stresses of a child's 
functioning oral cavity will be tested to find the most optimal design that 
will accommodate stresses and strains that will be distributed on the 
material. In addition, two types of 3D printing resins will be compared 
to the conventional stainless-steel stage at the Faculty of engineering 
labs, British University in Egypt (Ozkalayci and Yetmez, 2018; Sabeti 
et al., 2020). 
Evaluate and find the optimal design suitable for a resin space 
maintainer, then test Two different resin materials' properties vs. the 
conventional Band and loop using the finite element method simulating 
the forces in the oral cavity. 
 
Stage II: an in vivo study 
A randomized controlled trial split-mouth design will be conducted 
in the Pediatric Dentistry Department Outpatient Clinic, Faculty of 
Dentistry, Suez Canal University. Each child will have an indication for 
a single-tooth space maintenance to maintain space until the eruption 
of the successor or shedding of abutment teeth. The calculated sample 
size will be mentioned later.  
 
 
 

 
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II.2.Sample selection: 
Children will be considered eligible according to the following inclusion 
and exclusion criteria: 
II.2.a.Inclusion Criteria: (Kamki et al., 2021; Khalaf et al., 2022) 
(1) Apparently healthy children. 
(2) Children of both genders aged 6-9 years old. 
(3) Guardians agree to join the study and sign the informed consent. 
(4) Recent premature loss of primary first molars or having primary first 
molars indicated for extraction on both sides. 
(5) Sound buccal and lingual surfaces of abutment teeth (primary second 
molar and primary canine). 
(6) Good oral hygiene. 
(7) Absence of radiographic periapical pathology related to the abutment 
teeth. 
(8) Absence of abnormal occlusal conditions such as posterior crossbite, 
deep bite, and scissor bite. 
(9) All the indications for a band and loop space maintainer are met. 
II.2.b.Exclusion criteria: (Kamki et al., 2021; Khalaf et al., 2022) 
(1) The patient is not able to attend regular follow-up visits. 
(2) Allergic condition to any of the used materials. 
 
II.3.Sample Grouping: 
1. Finite element analysis groups: 
• Group A: 3D printing Resin I: Orthodontic Rigid Resin. 
• Group B: 3D Printing Resin II: Crown and bridge resin. 
• Group C: Stainless steel Band & Loop space maintainer 

 
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2. The in-vivo groups: 
The randomized controlled trial Randomization will occur by a coin 
flip which will be done for each patient to decide which side of the 
mouth is allocated to which group of the following: 
• Group I: Resin 3D printed space maintainer ( Material and design 
decided by the Finite Element Analysis). 
• Group II: Band and loop space maintainer. 
 
II.4.Study Procedures: 
a) Finite Element Analysis(Ozkalayci and Yetmez, 2018; Sabeti et 
al., 2020) 
➢ A Nissin pediatric training model will have its lower primary second 
molars removed. 
➢ An impression will be acquired with the intra-oral scanner. 
➢ A stainless-steel band and loop will be constructed and scanned. 
➢ A space maintainer will be designed with resin 3D printing in mind 
with the 3Shape appliance designer software. 
➢ Mouth and space maintainer model data will be exported to the FEA 
lab, Faculty of Engineering, British University in Egypt. 
➢ Discretization and meshing of the models will be done. 
➢ Boundary conditions will be applied. 
➢ Material properties like Young's modulus of elasticity and poisons 
ratio will be added. 
➢ Forces of occlusion will be added to the magnitude. 
 
 

 
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b) Clinical Procedures 
All participant's guardians will have the procedures explained to 
them, then they need to read and sign/stamp the informed consent 
(appendix1), and the participants will have a brief explanation and 
will check the informed Assent. 
Each side will be treated with a different group. Both impressions will 
be carried out at the same visit and the delivery of both groups will 
be done at the consecutive visit. 
➢ Stainless steel Band and Loop side: 
(a) A stainless-steel band appropriate for the abutment tooth distal to the 
space will be selected.  
(b) The Band will be seated on the tooth, contoured to adapt closely to 
the abutment teeth . 
(c) A complete arch impression using alginate impression material.  
(d) A metal loop fabricated in the lab is soldering to the Band . 
(e) Before cementation, the position of the loop will be checked, and 
abutment teeth will be cleaned with a polishing paste. 
(f) Isolation will be acquired using cotton rolls and low-volume suction . 
(g) G-Cem self-etching cement will be used to cement the Space 
maintainer. 
 
➢ Construction of 3D printed space maintainer: 
(a) Proper isolation using a cheek retractor and suction apparatus will be 
needed. 

 
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(b) The lower arch will be scanned using a distance ranging from 0-5mm 
to obtain an optical impression. 
(c) The. stl File of the model will be imported to the 3Shape Appliance 
Designer Program 
(d) The. stl File will also be imported to the 3Shape Ortho analyzer for 
space analysis and comparison. 
(e) The Space Maintainer will be designed. 
(f) The Space maintainer will be printed on the Rapidshape resin 3D 
printer. 
(g) The device will be washed and cleaned from excess resin. 
(h) Isolation using cotton rolls and low-volume suction will be done in 
the patient's mouth . 
(i) G-Cem self-etching cement will be used to cement the device. 
 
 
 
 
 
 
 
 
 
 
 
 

 
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II.5.Methods of Evaluation 
The patients will be recalled at 3, 6, 9, and 12 months to be evaluated for: 
a) Success and failure rate(Deshpande et al., 2018)  
1. Cement loss / Debonding. 
Any cement or debonding loss will be considered a failure if the space 
maintainer becomes loose. 
2. Fracture of the SM. 
If the SM is broken, fractures will be regarded as a failure. 
3. Caries of abutment teeth. 
Any caries of the abutment teeth will be regarded as a failure. 
 
b) The plaque index(Table 2) and the Gingival index (Table 3) of the 
abutment teeth as by Sillness and Loe(Özüdoğru and Tosun, 
2021). 
Plaque index (PI) (Table 2) and Gingival index (GI)(Table 3), as 
described by Sillness and Loe, will be used to monitor the gingival 
health and plaque accumulation at three scoring sites for each patient: 
(A) Banded or anchor abutment tooth (distal tooth). 
(M) Mesial abutment tooth. 
(C) Control molar tooth in the opposing arch. 

 
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A periodontal probe will be used before the placement of space 
maintainers and in follow-up visits. Each tooth will be examined around 
each tooth from the mesial, distal, buccal, and lingual areas. After scoring 
according to the table, it will be divided by 4 to give the score for the 
tooth. 
Table (2) Evaluation of the plaque deposits according to the (PI) described by Silness 
and Loe (1964): 
Score 
        Criteria for the plaque Index 
0 
No plaque 
1 
A film of plaque adhering to the free gingival margin 
and adjacent area of the tooth. The plaque may be seen 
in situ only after the disclosing agent or using the probe 
on the tooth surface. 
2 
Moderate accumulation of plaque in the gingival sulcus. 
3 
An abundance of soft matter within the gingival pocket 
and/or on the tooth and gingival margin. 
Table (3) Evaluation of the gingival health according to the (GI) described by (Loe 
and Silness, 1963): 
Score 
Criteria for the Gingival Index 
0 
No inflammation. 
1 
Mild inflammation: slight redness, slight edema, no 
bleeding on probing. 

 
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2 
Moderate inflammation: redness, edema, glazing, 
bleeding on probing. 
3 
Severe inflammation: marked redness and edema, 
ulceration, and a tendency of spontaneous bleeding. 
 
c) Measurements of Space difference before and after follow-up, 
measurements of any rotations: 
The ability of the space maintainer to maintain the space during the 
follow-up period will be evaluated by the linear and spatial relationships 
between the two abutment teeth.  
These measurements will be done on initial digital impressions and the 
follow-up impressions using the 3Shape Orth Analyzer software. The 
spatial measurements will demonstrate whether there was any rotating 
movement of teeth and any space loss. 
➢ Space Change: 
After the follow-up period, another scan will be made of the arch, and 
the 3Shape ortho-analyzer software will measure the space difference 
between the abutment teeth. 
➢ Rotations: 
The arch scans will be overlayed to calculate any angular changes during 
the space maintenance phase. 
 

 
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d)  Pain rating and Patient Satisfaction 
The patients will receive a pain rating survey during insertion and each 
visit. 
Wong–Baker Faces Scale Fig (1)  will be given to the patients on the first 
and the last visit to check patient satisfaction will be carried out (Ahmad 
et al., 2018). 
The patient will be asked to rate the following: 
1. Pain Experience 
2. Ease of mastication on each side. 
3. General satisfaction 
 
6. Statistical Plan 
6.1.Sample size calculation: 
The sample size was calculated using the G*power 3.1.9.2 Software 
based on success rate data of conventional band-and-loop space 
maintainers from a previous study(Tunc et al., 2012), reporting a 12-
month success rate of 90% compared to 20% of fiber-reinforced 
composite space maintainers. The power of the z-test was calculated to 
be 95%, using a two-tailed significance level of 5%. The calculated 
Figure 1 Wong-Baker FACES pain scale 

 
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sample size will be 10 primary second molars per group for a total of 
20. The sample size will be increased by 30% to 13 primary molars per 
group (26 in total) to compensate for dropouts. 
 
 
6.2.Statistical Analysis  
All the data will be calculated, tabulated, and analyzed using a 
suitable statistical test. In addition, a normality test (Kolmogorov-
Smirnov) will be done to check the normal distribution of the samples.   
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) at significant levels 0.05 (P- Value 
≤0.5). 
i. 
Descriptive data: 
Descriptive statistics will be calculated as Mean ± Standard deviation 
(SD), range (Max-Min).  
ii. 
ANOVA - test or Kruskal-Wallis test (According to the 
types of data)  
        Two ways ANOVA (Analysis of variance) or ANOV with repeated 
measures will be used to compare the groups and period interval 
under study. Post hoc tests will be performed to evaluate any statistical 
significance among the groups. P value < 0.05 is considered to be 
statistically significant.  

 
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iii. 
T-test or Mann-Whitney test (According to the types of 
data)                   
       Independent Student's T-test or Mann-Whitney will be performed 
for the pairwise comparison in the three groups at P value < 0.05. 
 
 
 
7. Ethics consideration 
For Clinical Studies (In - vivo Studies) 
     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 13 children in need of a bilateral single 
space maintainers. The researcher will undertake ethical considerations 
regarding patient well-being and confidentiality and informed written 
consent will be signed by the subjects’ guardian before commencing the 
study explaining all clinical examinations, procedures, and follow-ups. 
(Appendix 1) 
8. Time Plan  
• Starting time: after faculty approval of the protocol. 
• Ending time: after 24 months 
Activity/Mon
th 
1 
2 
3 
4 
5 
6
7
8
9
10
11
12
13
14
15
16
17
18 
19 
20
21 
22 
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Finite element 
analysis 
☒ ☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ ☐ 

 
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Patient 
selection and 
material 
collection 
☐ ☐ ☐ ☐ ☒ ☒ ☒ ☒ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ ☐ 
Follow-up 
☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☒ ☐ ☐ 
☐ ☐ 
Statistics 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☐ 
☐ ☐ 
Thesis writing ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☒ ☒ 
☒ ☐ 
Collection of 
thesis 
☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ 
☐ ☒ 
 
9. Research the Estimated Budget in Egyptian pounds and 
United States dollars 
Supplementary 
Publications 
Total 
histopathology 
drugs/ 
Lab chemicals 
Lab-
investigations 
Software 
Material 
Others 
(mention) 
 
 
Finite 
element  
analysis 
1500 USD  
University 
license  
2500 
USD 
Metal 
Band 
and 
loop lab 
work: 
7500 
2000 USD 
6000 
USD 
+ 
7500EGP 
 
 
 

 
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10. References 
Ahmad, A., Parekh, S., and Ashley, P., (2018). ‘Methods of space maintenance for 
premature loss of a primary molar: a review ̓. European Archives of Paediatric 
Dentistry Vol19, pp311–320.. https://doi.org/10.1007/s40368-018-0357-5 
Bhujel, N., Duggal, M., Saini, P., and Day, P., (2016). ‘The effect of premature 
extraction of primary teeth on the subsequent need for orthodontic treatment ̓. 
European 
Archives 
of 
Paediatric 
Dentistry 
Vol17, 
pp423–434.. 
https://doi.org/10.1007/s40368-016-0247-7 
Deshpande, S., Bendgude, V., and Kokkali, V., (2018). ‘Survival of Bonded Space 
Maintainers: A Systematic Review ̓. International Journal of Clinical Pediatric 
Dentistry Vol11, pp440–445.. https://doi.org/10.5005/jp-journals-10005-1554 
Dhanotra, K., and Bhatia, R., (2021). ‘Digitainers—digital space maintainers: A 
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(2021). ‘Clinical effectiveness of fiber-reinforced composite spacmaintainer and 
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Khalaf, K., Mustafa, A., Wazzan, M., Omar, M., Estaitia, M., and El-Kishawi, 
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Band and Loop Space Maintainer: A Digital Game Changer in Preventive 
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various sources of discoloration: An in vitro study ̓. Materials Vol13, pp1–13.. 
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11. Appendices   
 
 
 
 
 
 
  
Suez Canal University                                                                                                    
Faculty of Dentistry 
Research Ethics Committee (REC.) 
--------------------------------------------------------------------------------------------------------------------------- 
Investigator Application Form 
1-Name of researcher: Omar Assem Hanafi Hodhod 
2-Name of Department: Pediatric Dentistry and public health 
3-Adress of researcher: 16 Ahmed El Zomor Street, Nasr City, Cairo, Egypt 
a- Email:omarhodhod@gmail.com 
b- Phone number:01006688484 
1- Name (s) of Co-investigator (s): 
Dr. Mohammed Sherif 
Dr. Shaimaa Mahfouz 
Dr. Islam Tarek 
5- Grade of protocol: 
*M.Sc.   (     )          *Ph.D.  (  )        *Doctorate degree (D.Sc.)   (   ✓  )           *Other   (     ) 
*Domestic     (     )            *Multi-Centre within Egypt      ( ✓ )                 *International     (     ) 
6- Title of the research: Evaluation of a Novel 3D printed Space maintainer versus the 
traditional metal Band and Loop: An in-Vivo Study. 
 7-Type of the research: 
*Drug trial    (     )  *Surgical technique  (     )   *Investigative technique   (✓) 
*Devise study (     )  *Survey study  (      )   *Blood sampling (     )*Review of old records   (     ) 
8-Subjects of research: 
    *Children   (˂ 18 years): (  ✓ )    *Adults (>18 years)   (      ) 
 * Vulnerable groups (yes) or (no): The patients' ages range from 6-8years old 

 
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.-1- 
Suez Canal University                                                                                                     
Faculty of Dentistry 
Research Ethics Committee (REC.) 
9-Request is being made to waive(give-up) informed consent:    Yes: (     )              No: ( ✓ ) 
    If yes, please explain why? 
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: loss of the space maintainer, breakage of the space maintainer, 
caries of the abutment teeth, and gingival inflammation. 
14- List the potential benefits, if any, to the subjects: Free treatment, better aesthetics space 
maintenance, prevention of abutment caries, tilting, and rotation. 
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: 
Omar Assem Hanafi Hussien Hodhod 
2/3/2023 
 

 
Suez Canal University
 
Faculty of Dentistry
 
Scientific Research Ethics Committee
 
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16 May 2023 
 
Informed Consent Form for Medical Research on Volunteer Participants 
Participant Name (Patient): ........................................   Gender:................................... 
Age: .........................................   Date of Birth:........................... 
1. Research Title: 
Clinical Evaluation of a Novel 3D-Printed Space Maintainer Compared with Conventional Space 
Maintainers 
2. Scientific Background and Research Objectives: 
This study aims to introduce an innovative 3D-printed space maintainer design and compare it 
with conventional band-and-loop space maintainers through the following parameters: 
Clinical performance of the 3D-printed space maintainer versus conventional band-and-loop 
space maintainers over a specified period. 
3. Detailed Research Procedures: 
- Research Duration & Location: 24 months at Pediatric Dentistry Outpatient Clinics, Faculty of 
Dentistry, The British University in Egypt. 
- Number of Participants: 13 (patients and healthy volunteers) 
Inclusion Criteria: Children must meet all of the following: 
• 
Aged 6-9 years 
• 
Experienced premature loss of primary molars 
• 
Sound adjacent teeth (mesial and distal to edentulous space) 
Exclusion Criteria: Children will be excluded if they have: 
• 
Poor oral hygiene 
• 
Systemic diseases or medical conditions that could complicate treatment 
• 
Dental caries on adjacent teeth (mesial and distal to edentulous space) 
4. Research Procedures: 
• 
Your child's participation is voluntary 
• 
After examination at the Pediatric Dentistry Clinic to identify non-restorable primary 
molars and necessary radiographs: 

 
Suez Canal University
 
Faculty of Dentistry
 
Scientific Research Ethics Committee
 
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16 May 2023 
1. Dental impressions will be taken 
2. Two space maintainers will be placed: 
• 
   - Conventional metal band-and-loop on one side 
• 
   - Novel 3D-printed device on the contralateral side 
• 
Placement will require two visits 
• 
Follow-up appointments at 3, 6, 9, and 12 months 
Expected Research Benefits: 
• 
- Advancements in less painful pediatric dental treatments 
Direct Participant Benefits: 
• 
- Maintenance of space for permanent tooth eruption 
Scientific/Indirect Benefits: 
• 
- Development of improved treatment protocols 
5. Potential Risks: 
Fracture or debonding of space maintainers 
Possible gingival inflammation 
6. Compensation for Complications: 
Any complications will be fully treated at no additional cost 
7. Alternatives to Participation: 
Standard conventional treatment will be provided if you decline participation 
8. Confidentiality: 
Your information will remain strictly confidential and accessible only to the principal 
investigator. You will receive study results and any health-related findings. 
9. Right to Withdraw: 
You may withdraw at any time without penalty or explanation 
10. Biological Samples: 
Any collected samples will not be used for other research 

 
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Scientific Research Ethics Committee
 
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16 May 2023 
11. Contact Information: 
Principal Investigator: Omar Assem Hanafy Haddad 
Phone: 01006688484 
Alternate Contact: Dr. Shaimaa Mohamed Mahfouz Omar 
Phone: 01222328727 
Ethics Committee Chair: .................... Phone:.................. 
I confirm that I have read, understood, and consent to the research procedures described 
above. 
Participant in Research 
Principal Investigator 
Name: ................................ 
Signature: ......................... 
(Fingerprint): ..................... 
Omar Assem Hanafy Hussein Haddad 
Signature: ........................ 
Date: ............................ 
Note: Volunteers are entitled to a copy of this consent form 
Research Classification: 
☐ Master's Thesis Research 
☑ PhD Thesis Research 
☑ Unfunded Research 
☐ Funded Research Project 
Funding Agency: ..................................... 
Approved by Scientific Research Ethics Committee on: ..................................... 
This approval is valid until: ..................................... 
Committee Chair                                                                      Committee Seal