Accuracy, Stability and Safety of Orthodontic Mini-implant Template in the Infrazygomatic Crest Zone
Phase: NA
Conditions: Dental Implants, Dental Implantation
Sponsor: Universiti Sains Malaysia

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Accuracy, stability and safety of orthodontic mini-implant
template in the infrazygomatic crest zone
School of Dental Sciences
Universiti Sains Malaysia
Research Proposal
December 2024
Principal Investigator：Su Li
Main Supervisor: Dr. Norma Ab Rahman
Co-supervisors:
Wang Jing

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CONTENT
LIST OF TABLES....................................................................................................... 8
Chapter1....................................................................................................................... 9
INTRODUCTION........................................................................................................9
1.1 Background of the study.....................................................................................9
1.2 Temporary anchorage devices (TADS)............................................................11
1.3 Miniscrew template.......................................................................................... 12
1.4 Cone-Beam computed tomography (CBCT)....................................................13
1.5 Computer-Aided Design and Manufacturing(CAD/CAM)..............................13
1.6 Miniscrew implantation....................................................................................14
1.7 Digital model establishment.............................................................................15
1.8 Statement of problem....................................................................................... 16
1.9 Justification of the study...................................................................................17
1.10 Novelty of the research:................................................................................. 18

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1.11 Aim and Objectives of the study.................................................................... 19
1.11.1 Aim of the study......................................................................................19
1.11.2 Objective................................................................................................. 19
General objectives............................................................................................. 19
1.11.3 Research questions.................................................................................. 20
1.11.4 Research questions.................................................................................. 20
1.12Conflict of Interest Statement......................................................................20
Chapter 2 ................................................................................................................... 23
Literature review........................................................................................................ 23
2.1.1 Definition of Mini-Implant........................................................................23
2.1.1 History of Mini-Implant............................................................................ 24
2.1.3 Types of Mini-Implant.............................................................................. 24
2.1.4 Uses of Mini-Implant................................................................................ 22
2.1.5 Current status of research on Mini-Implant.............................................. 24
2.1.6 The success rate of miniscrew implantation..............................................24

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2.2 Miniscrew guide...............................................................................................33
2.2.1 The advantage of Mini-implant guide..........................................................33
2.2.2 The disadvantage of Miniscrew guide..........................................................33
2.2.3 The design of Miniscrew guide.....................................................................33
2.3 Approaches to Improve the safety and stability of Miniscrew........................35
2.3.1 Imaging technology.....................................................................................35
2.3.2 Miniscrew guide............................................................................................36
2.3.3 Miniscrew design.......................................................................................... 37
2.4 Digital model....................................................................................................40
2.5Computer-Aided Design and Manufacturing(CAD/CAM)...............................41
Chapter 3 ................................................................................................................... 42
MATERIAL AND METHODS................................................................................. 42
3.1 Study design..................................................................................................... 40
3.2 Population and sample......................................................................................42
3.2.1 References population............................................................................... 42
3.3 Source of population........................................................................................ 44

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3.4 Ethical approval................................................................................................44
3.5 Sample size calculation.................................................................................... 43
3.5.1 Objective 1................................................................................................ 41
3.5.2 Objective 2................................................................................................ 42
3.5.3 Objective3................................................................................................. 42
3.5.4 Objective 4................................................................................................ 43
3.6 Randomization of the subjects......................................................................... 43
3.7 Sample frame....................................................................................................47
3.7.1 Inclusion criteria........................................................................................47
3.7.2 Exclusion criteria...............................................................................................47
3.7.3 Withdrawl criteria..........................................................................................46
3.8 Flow chart of the study.....................................................................................49
3.9 Variables and tools........................................................................................... 50
3.9.1 Research tool............................................................................................. 51
3.9.2 Variables....................................................................................................52
3.10 Data collection and grouping......................................................................... 53

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3.11 Stages of treatment......................................................................................... 51
3.12 Design and fabrication of guide..................................................................... 59
3.13 Analyses and measurements:..........................................................................60
3.14 Statistical analysis.......................................................................................... 55
3.15 Analyses and measurements:..........................................................................62
3.16Sensitivity and interests of the community:.................................................... 62
3.17 Ethical review：.............................................................................................63
3.18Compensation :................................................................................................64
3.19 Possible benefit...............................................................................................64
Chapter 4 ................................................................................................................... 65
DUMMY TABLES.................................................................................................... 65
4.1 Annexure A...................................................................................................... 65
4.2 Annexure B.......................................................................................................66
4.3 Annexure C.......................................................................................................67
4.4 Gantt chart for research activities.....................................................................61

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4.5 Milestones and Dates........................................................................................62
4.6 References........................................................................................................ 63
5. APPENDICES........................................................................................................75

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LIST OF TABLES
Page
Table 2.1. Miniscrew Implantation by guide between tooth roots .................. 错误！未定义书签。8
Table 2.2 Miniscrew Implantation in palate.........................................................................................30
Table 2.3 Miniscrew Implantation in infrazygomatic crest zone....................................................... 34
LIST OF FIGURES
Page
Figure 2.2.1 Palatal mini-implant guide................................................................................................36
Figure 2.2.2 Guide made of archwire
.............................................................................................. 36
Figure 2.2.3 Guide made of archwire................................................................................................... 36
Figure 2.2.4 Guide with mini-screw spin-off slots.................................................................................. 37
Figure 2.2.5 Guide with sleeve..................................................................................................................37
Figure 3.12 A guide with a three-quarters circular hole........................................................................60
Figure 3.13 Digital 3D model....................................................................................................................61

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Chapter1
INTRODUCTION
1.1
Background of the study
Malocclusion is a term used in orthodontics to describe the improper alignment or
positioning of the teeth and the jaws. It refers to any deviation from the ideal
occlusion, which is the optimal alignment of the upper and lower teeth when the jaws
are closed. Malocclusion can involve various dental and skeletal discrepancies,
including crowding, spacing, misalignment, overbite, underbite, crossbite, open bite,
and other irregularities in the dental arches. In simpler terms, malocclusion is a
condition where the teeth and jaws do not fit together correctly, resulting in an
abnormal bite. It can affect the appearance, function, and oral health of an individual.
Orthodontic treatment aims to correct malocclusion and restore proper alignment,
improving both the aesthetic appearance of the smile and the function of the teeth
and jaws. The purpose of orthodontic treatment is to achieve a good functional bite
and an aesthetic facial appearance. For orthodontists, a good filial profile is one of
the most important parts of evaluating the effectiveness of orthodontic treatment.
Orthodontic treatment has gradually become an important way to improve personal
image and tends to be tailored, called personalized orthodontic treatment. With the
continuous progress of industrial technology, the application of Computer-Aided
Design/Computer-Aided Manufacturing （CAD/CAM ）and Cone beam CT
（CBCT）in orthodontics is becoming increasingly popular, providing hardware
support for personalized and accurate orthodontic treatment. Various personalized

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orthodontic devices have also emerged on this basis. Personalized orthodontic
devices are personalized orthodontic treatment tools tailored to patients based on
their individual tooth shape and arch characteristics, guided by the treatment target
position, through personalized tooth arrangement experiments, and utilizing 3D
digital design and printing technology. Microimplant or mini-screw, is a commonly
used anchorage for orthodontists, has been widely used in clinical practice and plays
an important role in solving difficult cases (Jones Jason P et al,2020) As a temporary
bone anchorage, miniscrew is easy to implant and remove. However, the anatomical
structure of the human body is complex, and the safety space is limited, so precise
implantation of miniscrew is necessary.
Miniscrews are generally implanted between tooth roots, but the space between them
is limited and there is a risk of injury to the roots (Kang Yoon-Goo et al,2009), so the
orthodontist often choose to implant miniscrews at the zygomatic alveolar ridge.
The zygomatic alveolar ridge has sufficient bone mass, and the double-layer bone
cortex of its buccal side and its top maxillary sinus can often be used to implant
anchorage screws. Moreover, the zygomatic alveolar ridge is high, close to the center
of resistance, and suitable for miniscrew implantation. However, bone mass and
thickness of the buccal bone cortex must be taken into consideration when
implanting miniscrews here to avoid damaging important structures such as the
maxillary sinus and tooth root (Liou EJ et al,2007).
However, current study found that up to now, the design of miniscrew template is
mainly applicable to tooth root (Kim SH et al,2007)and palate(Cassetta M et al,2018),
and rarely applicable to zygomatic alveolar ridge.

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Thus, the purpose of this study is to provide a digital orthodontic temporary
anchorage devices (TADs) design and application of orthodontic miniscrew template
by computer-aided design and manufacturing.
1.2
Temporary anchorage devices (TADS)
Ensuring anchorage control is essential for achieving successful orthodontic
treatment. However, traditional methods of enhancing anchorage often present
challenges such as large volume, complex structures, discomfort, and compromised
oral hygiene for patients. Additionally, the extended wearing period of extraoral
devices significantly impacts patients ’ quality of life. Therefore, the use of more
advantageous temporary anchorage devices (TADS) in orthodontic treatment is
becoming
increasingly
widespread.
The
clinical
operation
of
implant
nail
implantation is mainly determined by the doctor by observing the radiation film to
determine the implantation site, the position with the bilateral tooth roots, and the
relationship with the maxillary sinus. Based on personal experience, the implant nail
implantation operation is carried out. This clinical operation requires the surgeon to
have a clear understanding of the anatomical structure of the surrounding tissues and
extremely high experience requirements, otherwise it is very easy to cause damage to
the tooth roots and surrounding tissues (Kuroda S et al,2007). In addition, the risk of
implantation increases due to the number of tooth roots, the close distance between
adjacent tooth roots, and the large variation of root branching, which leads to many
young doctors being discouraged. Research has shown that the failure rate of implant
implantation is still relatively high, mainly due to touching or damaging adjacent
tooth roots during the implantation process （Lim G et al,2013）. Kang et al. found

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that when the implant nail damages adjacent tooth roots, it can reach up to 79 2% of
implant screws become loose, while the loosening rate without contact with the tooth
root is 8 3% indicates that the safety of planting nails is the key to success（Kang ,et
al,2009). The high requirements of clinical operation, the high harm caused by
improper operation, and the high failure rate seriously hinder the application of this
technology in clinical practice and its popularization nationwide
1.3
Miniscrew template
Miniscrew templates have become a useful tool in orthodontic treatment, providing a
guide for precise and accurate miniscrew placement. Research in this area has
focused on developing new miniscrew templates to improve their design and efficacy.
One key research direction has been on investigating the impact of different template
materials on their accuracy and stability. Studies have compared the accuracy of
templates made from acrylic, resin, and metal, exploring how these materials
influence stability and ensuring precise hole drilling for miniscrew placement.
Additionally, research has explored the use of computer-aided design (CAD) and
computer-aided
manufacturing
(CAM)
technologies
to
design
and
produce
customized miniscrew templates. Studies have investigated the accuracy and efficacy
of 3D-printed miniscrew templates, which allow for precise customization to a
patient’s specific anatomy and treatment needs.
Furthermore, researchers have explored the use of virtual planning software and
surgical guides to further optimize miniscrew template design. Studies have

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investigated the efficacy of using virtual surgical planning (VSP) software to plan
miniscrew placement and create customized surgical guides, which provide a
detailed guide for miniscrew insertion.
1.4
Cone-Beam computed tomography (CBCT)
Cone-beam computed tomography (CBCT) has been introduced for dental offices
because of the reduced costs and size (Patel et al., 2009a; Patel et al., 2009b). The
scans produced by a CBCT imaging system have a significantly reduced scan time,
reduced cost for the patient, and use a lower radiation dose than medical CT (Ziegler
et al., 2002; Scarfe et al., 2006). Different CBCT machines will have different
radiation doses determined by the particular brand, settings, and the area of the
mouth to be scanned. CBCT compensates for the disadvantage of the scanning
method, which is that only the crown can be scanned. It also provides significant
dose reductions of between 98.5% and 76.2% when compared to the patient dose
reported for maxillofacial imaging by conventional CT (approximately 2000 mSv)
(Scarfe WC,et al., 2008; Loubele M et al., 2009). Initial research on the accuracy of
CBCT focused on the evaluation of linear (Goodarzi ,et al., 2015; Sherrard JF et al.,
2010)or volumetric data, (Wang Y ,et al., 2011;
Tayman MA et al., 2019) and was
shown to be highly accurate with regard to alveolar bone defects and root length of
varying voxel sizes (0.125–0.40 mm) (Damstra J ,et al., 2010; Lyu H et al., 2023).
1.5
Computer-Aided Design and Manufacturing(CAD/CAM)
The current status of “ Dental CAD/CAM ” (Computer-Aided Design/Computer-
Aided Manufacturing) in the field of dentistry involves the application of advanced

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computer technologies for designing and fabricating dental restorations and
prosthetics with high precision and efficiency.
Dental CAD/CAM systems utilize specialized software and hardware to digitally
create 3D models of dental structures, such as crowns, bridges, and dentures. These
models are designed based on digital scans of patients ’ teeth or oral structures,
obtained through intraoral scanners or cone beam computed tomography (CBCT).
Once the digital models are created, the CAD software allows dental professionals to
design customized restorations with optimal fit, form, and function. They can
manipulate the shape, size, and contours of the restorations, ensuring precise
adaptation to the patient’s dental anatomy. The software also enables the selection of
appropriate materials and colors.
After the design phase, the CAM component of the system takes over. CAM
software communicates with dental milling machines or 3D printers to accurately
fabricate the designed restorations from various materials, such as ceramics, zirconia,
or resin. The milling machines can precisely carve restorations from blocks of
material, while 3D printers can produce intricate prosthetics using additive
manufacturing techniques.
1.6
Miniscrew implantation
Orthodontic mini-implants have become an increasingly popular and effective option
in providing orthodontic anchorage. Research in this area has focused on improving
the accuracy and stability of mini-implant placement, as well as developing new
designs and materials to optimize their function.

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One major research focus has been on using imaging technology to improve implant
placement accuracy. Advances in cone-beam computed tomography (CBCT) have
allowed for more thorough and detailed 3D imaging of the patient’s jaw structure,
aiding in the identification of ideal placement sites. Additionally, computer-aided
implant placement (CAIP) systems have been developed to guide the implantation
process and improve accuracy.
Another research direction has been on improving the success rate and stability of
mini-implants over time. Studies have explored the use of different implant designs
and materials, such as tapered, self-tapping, and surface-treated implants, to enhance
osseointegration and stability within the jawbone. Additionally, research has
investigated the impact of implant diameter, length, and placement depth on the
success of mini-implants.
Furthermore, researchers have examined the effect of implant placement on the
surrounding teeth and tissues. Studies have investigated the impact of mini-implants
on root resorption, periodontal health, and soft tissue irritation, and have suggested
strategies to minimize these effects.
1.7
Digital model establishment
After the 1990s, the application of digital 3D modeling of teeth and jaws in dentistry
has become increasingly widespread.
Researchers have developed three-dimensional (3D) scanning techniques to capture
the geometry and texture of oral structures, including teeth, gums, and surrounding

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tissues. These digital scans are then processed and converted into accurate and
detailed virtual models, providing an alternative to traditional plaster models.
Digital oral models offer several advantages over traditional models. Firstly, they
enable enhanced visualization and analysis of dental structures, allowing for
improved treatment planning and evaluation. Dentists can manipulate the digital
models, measure distances, angles, and volumes, and simulate treatment outcomes.
In addition, digital models facilitate communication and collaboration among dental
professionals. They can be easily shared, stored, and accessed remotely, enabling
interdisciplinary consultations and efficient treatment coordination.
Moreover, digital oral models serve as a valuable resource for dental research and
education. Researchers can use these models to study various dental conditions,
simulate treatment interventions, and investigate the efficacy of different procedures.
Dental students can also enhance their learning experience by practicing virtual
procedures on these models.
Despite these advancements, challenges remain in the adoption of digital oral models.
Standardization, interoperability, and data security are areas that require further
attention. Additionally, the cost of acquiring and maintaining the necessary
technologies may limit widespread implementation.
1.8
Statement of problem
The use of mini-implant anchored orthodontic template is a relatively new technique
in orthodontics that shows promise for improving treatment outcomes. However,

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there is a lack of comprehensive research investigating the effectiveness and
efficiency of this approach.
The problem statement for this research paper focuses on the need to evaluate the
clinical outcomes, stability, patient comfort, and treatment duration associated with
mini-implant anchored orthodontic guide. Additionally, it aims to address the
limitations and challenges faced in the current available literature on this topic,
including the lack of standardized protocols, inconsistent findings, and potential
complications.
Moreover, considering the growing popularity of mini-implant anchored orthodontic
template among orthodontists and patients, it is crucial to establish evidence-based
guidelines and protocols to ensure the successful integration of this technique into
orthodontic practice. Therefore, the problem statement seeks to explore the current
gaps and limitations in the existing literature and provide valuable insights into the
clinical benefits and drawbacks of utilizing mini-implant anchored orthodontic plates.
1.9
Justification of the study
The development of miniscrew template is of great significance in the field of
orthodontic surgery. These devices provide a precise and efficient means of inserting
screws into the bones of patients, especially in cases where the case is difficult. The
use of miniscrew template greatly simplifies the surgical procedure, reducing both
the risk of error and the overall time required for the operation.

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Additionally, the use of miniscrew template has been shown to result in improved
orthodontic outcomes, such as increased stability of the miniscrew. This can lead to
reduce risk of complications such as implant migration.
Therefore, this study aims to provide a standardized protocol for designing and
fabricating mini-implant anchored orthodontic plates, which can improve the overall
clinical outcomes, patient comfort, and treatment efficiency. The findings of this
study can also open new avenues for future research on advancing the miniscrew
template design and fabrication techniques, leading to further innovation and
improvement in orthodontic treatment modalities.
1.10 Novelty of the research:
The research on miniscrew template presents several novel aspects in the field of
orthodontic surgery. Firstly, the development of this technology introduces a more
precise and efficient method for inserting small diameter screws into bones. This
represents a significant advancement compared to traditional methods, which often
rely on freehand techniques and can be prone to errors. The introduction of
miniscrew template provides surgeons with a standardized and reliable tool to
achieve accurate screw placement.
Moreover, the use of miniscrew template allows for minimally invasive procedures,
reducing the need for open surgery. This innovation not only enhances patient
comfort but also minimizes the risk of complications associated with invasive
surgical techniques. The ability to achieve comparable stability and outcomes
through a less invasive approach is a noteworthy contribution to the field.

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Finally, the production of guide plates is a fully digital design. The guide plate is
suitable for the infrazygomatic crest zone, ensuring the accuracy of the implantation
position and avoiding damage to important structures.
1.11 Aim and Objectives of the study
1.11.1
Aim of the study
This research aims to investigate the potential benefits of application new modified
designed
of
orthodontic
miniscrew
template
by
computer-aided
design
and manufacturing in improving the accuracy and efficiency of panel installation in
miniscrew application.
1.11.2
Objective
General objectives
The general objective of this research is to study the effect of utilizing modified
miniscrew template as tools for the miniscrew placement.
Specific Objective
The specific objectives for this study will be:
1. To compare the accuracy of miniscrews implanted using modified template by
computer-aided design and without template guide (conventional method).

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2. To compare the stability of miniscrews implanted using modified template by
computer-aided design and without templete guide (conventional method).
3. To compare the safety of miniscrews implanted using modified template by
computer-aided design and without templete guide (conventional method).
4. To compare the accuracy of miniscrew implantation between using CBCT and
digital model investigating.
1.11.3
Research questions
1.What is the effect of the accuracy of miniscrews implanted with and without guide?
2.What is the effect of the stability of miniscrews implanted with and without guide?
3.What is the effect of the safety of miniscrews implanted with and without guide?
4.What is the difference in accuracy of miniscrew implantation between using CBCT
and digital model investigation?
1.11.4 Alternative hypotheses
1. There is a significant difference in the accuracy of miniscrews implanted with and
without guide.
2. There is a significant difference in the stability of miniscrews implanted with
and without guide.

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3. There is a significant difference in the safety of miniscrews implanted with and
without guide.
4. There is a significant difference in the accuracy of miniscrew implantation
between using CBCT and digital model investigating.
Chapter 2
Literature review
2.1 Mini-implant
2.1.1
Definition of Mini-Implant
Orthodontic micro-implant nails (also known as orthodontic implants, orthodontic
micro-implants, and temporary anchorage device) are small implants used in
orthodontic treatment that are often used to provide additional support and anchorage
to aid in tooth movement and the straightening process. These micro-implant nails
are usually made of titanium alloy or other biocompatible materials, and their shapes
and sizes are carefully designed to accommodate different treatment needs.

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2.1.2
History of Mini-Implant
The concept of orthodontic micro-implant originally dates back to the 1980s, but it
is only in recent years that they have come to receive widespread attention and
research. With the advancement of medical technology and material science, the
design and application of mini-implantshave been continuously improved, bringing
new possibilities to the field of orthodontics.
2.1.3
Types of Mini-Implant
According to their different designs and uses, orthodontic micro-implant nails can be
divided into various types, micro-implant nails with different head designs, etc. Each
of these mini-implant nails has its own characteristics. Each of these TADS has its
own characteristics and can be selected and applied according to the patient's specific
situation and treatment needs.
2.1.4
Uses of Mini-Implant
Orthodontic micro-implant nails play an important role in the clinic in the following
ways:
1. Providing additional support and anchorage: TADS can provide additional
support and anchorage points during tooth movement, helping to hold one or more
teeth in place, preventing unwanted tooth movement and facilitating effective
orthodontic treatment.

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2. Expanding the scope and possibilities of orthodontic treatment: For some
complex tooth movement and orthodontic cases, traditional orthodontic methods may
have limitations. The introduction of micro-implant pegs can expand the scope of
orthodontic treatment, providing more treatment options and possibilities, and
making problems that would otherwise be difficult to solve possible.
3. Facilitating tooth movement and orthodontic results: The application of TADS
can help improve tooth movement and facilitate the orthodontic process. They can be
used in conjunction with traditional orthodontic treatments to achieve faster and
more effective orthodontics, shortening the treatment cycle and improving the
predictability and success rate of treatment.
4. Solving treatment challenges in complex cases: In some complex orthodontic
cases, such as severe crowding and severe resorption of the alveolar bone, TADS
can play an important role in helping doctors to solve the treatment challenges and
improve the treatment effect and aesthetic results.

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2.1.5
Current status of research on Mini-Implant
In recent years, a growing number of studies have been devoted to evaluating the
effectiveness of orthodontic mini-Implant in different types of orthodontic cases,
implantation stability, complication rates, and other factors. These studies have
explored in depth the implantation technique, biological response and long-term
results of micro-implant nails through clinical experiments, imaging evaluations and
biomechanical analyses. As research continues, guidelines and best practices for the
application of TADS are being refined and updated.
2.1.6
The success rate of miniscrew implantation
Alberto Conso laro believes that the shape of the alveolar ridge between teeth is
flexible and variable(Voss PJ ,et al., 2014). Therefore, the reasons for the failure of
orthodontic micro implants are often related to the structure of the alveolar bone,
which can generally be attributed to the following reasons: the implant site is
inclined towards the alveolar ridge of the upper and lower jaws. Miniscrew
implantation is too close to the periodontal ligament, resulting in low bone density,
low thickness, low alveolar bone volume, and low cortical bone thickness, which
leads to poor fixation of the implant.Excessive pressure during implantation leads to
slight fracture of the trabecular bone.. In addition to the alveolar bone structure,
when implanting miniscrewss without considering the thickness of gingival tissue
and the width of the attached gingiva, it may easily lead to periimplantitis, resulting
in implant anchorage failure (Spinato S,et al., 2017). Other factors, including the

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shape, length and diameter of the miniscrew, the immediate and early loading size of
the implant, can also have a significant impact on the success rate of the implant.

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Table 2.1. Miniscrew Implantation by guide between tooth roots
Author name
Imaging evaluation
Results
Ken Miyazawa et al (2010)
CBCT
No miniscrew was found
to be in contact with a
root either at insertion or
before removal, both in
the upper and in the
lower arch.
Janghyun Paek,
et al. (2014)
3D model
scanner
The use of a custom-
made, rigid guide when
placing miniplates will
minimize complications
such as vertical
mislocation or slippage of
the miniplate during
placement.
Matheus Melo Pithon
et al (2010)
Periapical radiograph
The present surgical guide
allows a controlled and
accurate palatal
miniscrew placement in
three dimensions.
Eduardo Yugo Suzuki, et al
(2008)
Periapical radiograph
The 3D surgical guide
provides a precise method
for miniscrew placement
into the dentoalveolar
bone.
Georgios Vasoglou, et al
(2022)
CBCT and intraoral
scanning
A 3D designed and
manufactured surgical
guide with information
concerning CBCT and
intraoral scanning ensures
accuracy on mini-implant
placement while design of

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the guide without the use
of a CBCT is less accurate,
especially on inclination of
the implant.
Yu-Tzu Wang, et al (2017)
CBCT/laser scan image
superposition
This study addressed
integrating CBCT and laser
scan image superposition;
CAD and 3DP techniques
can be applied to
fabricate an accurate
customized surgical
template for dental
orthodontic miniscrews.
Hong Liu, et al (2010)
CT
The proposed template
has high accuracy and will
be especially useful for
patients who require
precise miniscrew
placement.

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Table2.2 Miniscrew Implantation in palate
Author name
Imaging evaluation
Results
Antonino Lo Giudiceet al
(2020)
CBCT
A case report about
Maxillary Skeletal
Expander (MSE)
VincenzoRonsivalle1,
et al (2023)
intra-oral scan (IOS) and
CBCT scans of each guide
was generated were
imported into Blue Sky
Plan* (USA)
A certain amount of
clinical deviation can
occur between planned
and achieved position of
orthodontic miniscrews
in the anterior palate.
Giorgio Iodice
et al (2010)
models were scanned
using a 3D model
scanner
Both direct and 3D-
assisted TAD insertion
methods are safe and
accurate in the anterior
palate. However, the use
of insertion guides could
facilitate TAD insertion,
providing the opportunity
to use palatal implants to
the less-experienced
clinicians.
Michele Cassetta
et al.(2019)
CBCT and dental
digital model images
Miniscrew-supported
distal jet appliance can
be used safely for first
upper molar distalization.
Daniele Cantarella
et al (2020)
the digital model of dental
arches and cone-beam
computed tomography
(CBCT).
In the present case
report, the digital
planning was associated
with a positive outcome
of maxillary expansion
and protraction in safety
conditions

29
M. Cassetta,
et al. (2018)
the fusion of cone-beam
computed tomography
(CBCT) and digital dental
model images
The present surgical
guide allows a controlled
and accurate palatal
miniscrew placement
in three dimensions.
Diego Sánchez- Riofrío
et al. (2020)
CBCT
Digital models, CBCT and
CAD/CAM technology,
are essential to
accomplish the goals
proposed in this article.
Kristian Kniha et al. (2021)
Preoperative lateral
cephalograms;
postoperative CBCT
The accuracy of an OMI
position can be
significantly increased by
using a guide extension
over the teeth. Vertical
implant positions
presented the lowest
deviations. Postoperative
oral scans and CBCTs
represent diverging
accuracy measure
ments when compared
with virtual planning
Jae-Jung Yua et al. (2012)
CBCT
The accuracy of an OMI
position can be
significantly increased by
using a guide extension
over the teeth.
Vertical implant positions
presented the lowest
deviations. Postoperative
oral scans and CBCTs
represent diverging
accuracy measurements
when compared with

30
virtual planning.
Maria R.et al. (2023)
CBCT and Intraoral scans
images
The 3D-printed SGs did
not reach the accuracy of
the conventional SGs
made of Pattern Resin
but may provide
sufficient accuracy for
palatal OMI placement.
Silvia Izabella Pop.et al.
(2022)
CBCT
1. Disinfection with 4%
Gigasept (Gigasept Instru
AF; Schülke & Mayer
Gmbh, Norderstedt,
Germany) is suitable both
for SLA- and DLP-printed
surgical guides.
2. Heat sterilization at
both 121 ◦C and 134 ◦C
modifies the mechanical
properties of the
surgical guides and is not
recommended as a
sterilization method for
surgical guides
intended for mini-implant
placement.
Jian-Hong YU.et al. (2018)
CBCT
Using FE analysis for
biomechanical evaluation
and combining with CT
image, image
superimposed method
and CAD technique can
fabricate
accuracy/security
customized surgical
template for mini-screws
with better primary

31
stability.
Lucia Pozzan .et al. (2022)
CBCT
1. All operative steps
contribute to a certain
degree of deviations that
lead to a cumulative
efect.
2. Te laboratory step has
a smaller infuence on the
angular deviations
between planned and
inserted miniscrews than
the clinical steps.
3. Cases with 2 TADs can
be successfully
performed with a 1-visit
protocol must be
approached with caution,
given the lower degree of
tolerance of the system.

32
Table 2.3. Miniscrew Implantation in infrazygomatic crest zone
Author name
Imaging evaluation
Results
Li Su et al
(2022)
the digital model of dental
arches and cone-beam
computed tomography
(CBCT).
In the vertical direction,
the accuracy of
implantation with the
template is higher than
that of the tradi-tional
method without the
template to avoid
piercing the maxillary
sinus mucosa in the
infrazygomatic crest zone

33
2.2
Miniscrew guide
2.2.1
The advantage of Mini-implant guide
Mini-implant were placed more accurately when using surgical guides than when
using a conventional method（Bae MJ et al.,2013). The accurate insertion of mini-
implant using the
guide allows doctors to precisely transfer the radiographic
information from preoperative design to the surgical, thus minimizing the risks of
root and injury (Suzuki EY et al.,2008). This novel approach is also leading to short
orthodontic treatment time, minimal discomfort, and great patient acceptance.
2.2.2
The disadvantage of Miniscrew guide
The use of guide plates can easily lead to greater economic costs. It is always lead to
the additional biological cost such as CBCT. We also need to consider the
complications such as the breakage of the surgical guide itself during its use (Lo
Giudice A et al.,2021)
2.2.3
The design of Miniscrew guide
The most common currently is the palatal mini-implant guide. As described in
Figure 1,the surgical guide has designed some holes aimed at the correct positioning
control(Cassetta M et al.,2013).As described in Figure 2,the surgical guide is made
of archwire(Pithon MM et al.,2010).As described in Figure 3,the 3D surgical guide

34
can connect to any desired position by the archwire (Suzuki EY et al.,2008).As
described in Figure 4,mini-screw spin-off slots were designed on the surgical
template(Yu JH et al.,2018).As described in Figure 5,templates fabricated by SLA
bonded with guided sleeves in the trajectory (Liu H et al,2010).
Figure 2.2.1 Palatal mini-implant guide
Figure 2.2.2 Guide made of archwire
Figure 2.2.3 Guide made of archwire

35
Figure 2.2.4 Guide with mini-screw spin-off slots
Figure 2.2.5 Guide with sleeves
2.3
Approaches to Improve the safety and stability of Miniscrew
2.3.1
Imaging technology
After the 1990s, the application of digital 3D modeling of teeth and jaws in dentistry
has become increasingly widespread.
Researchers have developed three-dimensional (3D) scanning techniques to capture
the geometry and texture of oral structures, including teeth, gums, and surrounding

36
tissues. These digital scans are then processed and converted into accurate and
detailed virtual models, providing an alternative to traditional plaster models.
Digital oral models offer several advantages over traditional models. Firstly, they
enable enhanced visualization and analysis of dental structures, allowing for
improved treatment planning and evaluation. Dentists can manipulate the digital
models, measure distances, angles, and volumes, and simulate treatment outcomes.
In addition, digital models facilitate communication and collaboration among dental
professionals. They can be easily shared, stored, and accessed remotely, enabling
interdisciplinary consultations and efficient treatment coordination.
Moreover, digital oral models serve as a valuable resource for dental research and
education. Researchers can use these models to study various dental conditions,
simulate treatment interventions, and investigate the efficacy of different procedures.
Dental students can also enhance their learning experience by practicing virtual
procedures on these models.
Despite these advancements, challenges remain in the adoption of digital oral models.
Standardization, interoperability, and data security are areas that require further
attention. Additionally, the cost of acquiring and maintaining the necessary
technologies may limit widespread implementation.
2.3.2
Miniscrew guide
In recent years, with the rapid development of digitalization in oral applications,
more accurate research methods have been provided for clinical doctors （Bae MJ et

37
al,2013). Qiu Lingling reconstructed teeth and jawbone models using CBCT,
determined the three-dimensional spatial position of the tooth root using software
such as Minics, designed the implantation position and angle, successfully printed
resin guide plates, and implanted implant screws（Qiu L et al,2012）. Lo et al.used
CBCT for digital design and printing of maxillary implant nail assisted arch
expansion devices, and achieved good clinical treatment results(Lo et al,2020). This
project successfully combines CBCT and 3Shape intraoral scanning data, uses
software to establish an accurate three-dimensional integrated dental model,
accurately evaluates the three-dimensional spatial position relationship of teeth,
designs personalized micro implant guide plates based on patient treatment
conditions, and finally produces personalized high-precision metal implant guide
plates through CAD/CAM rapid printing, which are applied in clinical practice.
2.3.3
Miniscrew design
Miniscrews have become an important component in orthodontic treatment,
providing a reliable source of anchorage for tooth movement. Research in this area
has focused on developing new miniscrew designs to optimize their function and
stability.
One research direction has been on investigating the effect of thread design on
miniscrew stability. Studies have explored the impact of thread pitch, depth, and
shape on the successful insertion and stability of miniscrews. Additionally, research
has examined the use of self-drilling or self-tapping miniscrews, which eliminate the
need for predrilling a pilot hole prior to insertion.

38
Another research focus has been on the use of surface treatments to improve
miniscrew stability. Studies have investigated the impact of different surface
treatments, such as acid etching, sandblasting, and anodizing, on the osseointegration
and stability of miniscrews. Additionally, research has explored the use of
biomaterial coatings, such as hydroxyapatite and titanium dioxide, to enhance the
osseointegration of miniscrews.
Furthermore, researchers have explored the impact of miniscrew design on patient
comfort and acceptance. Studies have investigated the use of miniscrews with
different head designs, such as flat, square, or dome, to minimize tissue irritation and
discomfort during treatment. Additionally, research has examined patient satisfaction
with miniscrew design and ease of use.
2.4
Digital model
There is currently no consensus on which technology is most accurate for modeling
(Akyalcin et al.,2013;Flügge TV et al.,2013).Different modeling methods have their
own advantages and disadvantages. The most commonly used digital 3D modeling
methods in clinical practice include laser 3D scanning technology, CT scanning
technology, and direct intraoral scanning technology.Akyalcin et al. established three
digitalization models for 30 orthodontic patients and found that the deviation of laser
scanning is the smallest and its accuracy is better than CBCT(Akyalcin et al.,2013).
Kim et al. established laser scanning digital models, physical models, and CBCT
digital models for 60 orthodontic patients and measured their tooth width, arch length,
and width. They found that the accuracy of laser scanning digital models was
high( Kim et al .,2014). Kim et al. measured the anterior and full tooth bolton ratios

39
of 50 patients and found that laser scanning had higher accuracy compared to
CBCT(Kim et al.,2016).
2.5Computer-Aided Design and Manufacturing(CAD/CAM)
Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) is
becoming increasingly mature and plays a crucial role in stomatology.3D printing
technology as a rapid prototyping technology that is a widely used technique in
stomatology in the 20th century.The new industrial manufacturing technology
developed in the late 1980s was initially used in industries such as aviation and
aerospace.It refers to the use of materials such as photosensitive resins to layer
computer-aided design models through design software.A technique of layer by layer
stacking, editing and shaping contours to create a three-dimensional solid model.
CAD/CAM technology is a means of transforming virtual designs into entities (Voss
PJ ,et al., 2019).

40
Chapter 3
MATERIAL AND METHODS
3.1
Study design
This is a Randomised control trial.
3.2
Population and sample
3.2.1
References population
Orthodontics patients which is require to implant miniscrew as anchorage requirement
at the Department of Stomatology, Xuanwu Hospital of Traditional Chinese Medicine.
3.3
Source of population
The samples will be recruited from the Dental Clinic, Beijing Xuanwu Traditional
Chinese Medicine Hospital , Beijing Xuanwu TCM Hospital.
3.4
Ethical Considerations
Ethical approval has been obtained from
Beijing Xuan Wu Hospital of
Traditional Chinese . This study will apply for ethical approval from the
Human Research Ethics Committee of USM.
This clinical trial will also planned to register in Clinical trial.gov.my.

41
Before collecting any personal data, ensure that all participants understand the
purpose of data use and obtain their written consent.
All researchers will
participate in
data protection and privacy training to
ensure they understand and comply with data protection policies.Establish a
security incident reporting mechanism to ensure that any security incidents can
be reported and handled in a timely manner.
3.5
Sample size calculation
Sample size were determined using power and sample size calculation software
(version 3.1.9.7) (Dupont and Plummer 1990). Since the sample size calculated for
other objectives gave less number of subjects in each group, therefore the sample
size selected in this research is based on objective of miniscrew implantation. The
given below are the categorization as per objective.
3.5.1 Objective 1
Sample size calculation based on the objective 1 related to the
of guide on the
miniscrew implantation. In a previous study the response within each subject group
was normally distributed with standard deviation 1.82437mm(Su Li,Song Hui and
Xiaofeng Huang,2022). If the true difference in the experimental and control means
is 2.7403, the research will need to study 8 experimental subjects and 8 control
subjects to be able to reject the null hypothesis that the population means of the
experimental and control groups are equal with probability (power) 0.8. The Type I

42
error probability associated with this test of this null hypothesis is 0.05.The effective
size is 1.5451013.
3.5.2 Objective 2
Sample size calculation based on the objective 1 related to the
of guide on the
miniscrew implantation. In a previous study the response within each subject group
was normally distributed with success rate 86%,failure rate 2% (Lim H, et al.,2011).
The research will need to study 8 experimental subjects and 8 control subjects to be
able to reject the null hypothesis that the population means of the experimental and
control groups are equal with probability (power) 0.8. The Type I error probability
associated with this test of this null hypothesis is 0.05.
3.5.3 Objective3
Sample size calculation based on the objective 1 related to the
of guide on the
miniscrew implantation. In a previous study the response within each subject group
was normally distributed with standard deviation 0.12mm(Janson G, et al.,2013). If
the true difference in the experimental and control means is 0.66, the research will
need to study 10 experimental subjects and 10 control subjects to be able to reject the
null hypothesis that the population means of the experimental and control groups are
equal with probability (power) 0.8. The Type I error probability associated with this
test of this null hypothesis is 0.05.The effective size is 1.3929508.

43
3.5.4 Objective 4
Sample size calculation based on the objective 1 related to the
of guide on the
miniscrew implantation. In a previous study the response within each subject group
was normally distributed with standard deviation 0.02 um(Talaat S,, et al.,2017). If
the true difference in the experimental and control means is 0.54, the research will
need to study 6 experimental subjects and 6 control subjects to be able to reject the
null hypothesis that the population means of the experimental and control groups are
equal with probability (power) 0.8. The Type I error probability associated with this
test of this null hypothesis is 0.05.The effective size is 1.799001.
Thus, a total sample size for this study will be 24 (12 for experimental and control
group) after considering 20% drop-out.
3.6
Randomization of the subjects
The simple randomization method involves randomly assigning subjects to different
groups. This means that each subject has an equal chance of being placed in any of
the groups. The randomization process is typically done using a random number
generator or a randomization table. This method helps ensure that the assignment of
subjects to groups is unbiased and eliminates any potential selection bias. Therefore,
it allows for a fair comparison between the groups and enhances the internal validity
of the study.
Randomization:
In this study, participants will be randomly assigned to either the Intervention
group or the control group using a computerized random number generator.

44
We will use simple randomization. Assuming 24 participants, we randomly
assigned them to two groups (trial and control) of 12 participants each. The
steps are as follows: generate 24 random numbers using a random number
generator. Sort these random numbers. The first 12 were assigned to the
intervention group and the last 12 to the control group. Ensure that participants
are assigned to the corresponding group in this order.
Matching:
To control for potential confounding variables, participants will be matched
based on key characteristics such as age, gender, and baseline health status. The
study involves comparing treatment outcomes in two groups, participants will
be paired so that each pair consists of individuals with similar baseline
characteristics.
Blinding:
The study will employ a particular-blind design to minimize bias. The
participants and the researchers administering the interventions will be aware
of the group assignments.And the researchers who interact with participants
and collect data will be unaware of group assignments. This blinding helps to
prevent expectations or biases from influencing the outcomes and ensures that
the study results are more reliable.
3.7
Sample frame
3.7.1
Inclusion criteria
(1) The orthodontic clinical design should include the use of miniscrews for
anchorage requirements in maxillary arch.
(2) Age of 18-35 years old

45
(3) Patients must have no prior history of orthodontic treatment and must have a
healthy periodontal condition or no history of trauma before the current orthodontic
treatment.
3.7.2
Exclusion criteria
(1) Patient with poor oral hygiene, history of systemic diseases and metal
allergies;
(2) Patients with osteoporosis and inability to retain the TAD;
(3) Patients who require orthognathic surgery for severe skeletal malocclusion;
(4) Smoking patients which will affect the success rate of the implant placement
(5) Patients with incomplete medical records.
3.7.3 withdrawal criteria
(1)Patient’s miniscrew implantation positiondevelops an infection
(2)Patient who produces persistent pain or discomfort that cannot be managed
(3)Significant bone resorption around the miniscrew site
(4.)The miniscrew becomes loose or shifts position,
(5)Patient who is allergicto the material of the miniscrew

46
3.8
Flow chart of the study
Patients randomly divided into 2 groups with randomization
Inclusion criteria and exclusion criteria
Reference population: Orthodontic patient Chinese ethnic group
Source population: Orthodontic patient in Beijing TCM hospital

47
3.9
Variables and tools
3.9.1
Research tool
3.9.1.1 Routine orthodontics records before treatment
History and examination record sheet
Accuracy evaluation
Safety evaluation
Intervention Implantation
Data collection and Comparison of all groups
Result
Analysis
Conclusion
Control Implantation (N=12)
Stability evaluation
CBCT (N=6)
Digital model (N=6)

48
Digital model
CBCT
3.9.1.2 Routine orthodontics records after treatment
Digital model
Dental record models
CBCT
3.9.1.3 Special need to conduct the research
Ordinary gypsum (Hubei Jingmen Shishengtang Gypsum Industry .)
Dental alginate impression material (Beijing Hongye Dental Medical Equipment
Factory)
Micro implant nail (Ningbo Cibei Medical Equipment )
Screwdriver (Ningbo Cibei Medical Equipment .)
Guide plate resin material (Beijing Xikema Medical Equipmen)
3D Metal Materials (Beijing Xikema Medical Equipment )
CBCT (5G, version FP; NewTom, Verona, Italy)
Software Segma Guide (Beijing Xikema Medical Equipment )
D700 scanner (3Shape, Denmark)

49
Itero scanner(invisalign,American)
3D printer (Beijing Xikema Medical Equipment)
3.9.2
Variables
3.9.2.1 Dependent variables
Clinical variables
-Looseness of mini-implant
-Shedding rate of mini-implant
-depth of exploration,
-gingival type
-gingival color and texture
-plaque index
-bleeding index
3.9.2.2 Variables for digital dental models acquisition
Distant of the root to the miniscrew tip
Distant between miniscrew tip to the maxillary sinus

50
3.9.2.3 Variables for CBCT acquisition
-the linear deviation of the tip and cap of the TADs in the mesio-distal, buccal-
lingual, and vertical three-dimensional directions
-the angle deviation of the head and tail of the TADs in the mesio-distal, buccal-
lingual, and vertical three-dimensional directions
-the distance between TADs and tooth root and maxillary sinus, and the distance
between two tooth roots.
-The thickness of the inner and outer walls of the maxillary sinus
-the root resorption
-the thickness of the lingual bone of the TADs
-the thickness of the cancellous bone.
3.9.2.4 Independent variables
Gender
Age
3.10
Data collection and grouping
Twenty four (24) individuals who met the criteria will be randomly divided into 2
groups, 12 will be selected as the experimental group and mini-implants will be

51
implanted using guide plates, while others 12 participants will be selected as the
control group and implanted mini-implants based on experience and no guide plates.
The recruitment will take about two months, using hospital bulletin boards and
social media at Beijing Xuanwu TCM Hospital. All routine orthodontic
diagnostic records will be collected. The patient was asked to sign an informed
consent form before surgery, which took about 20 to 30 minutes. The doctor
implanted the miniscrew, and the operation time was about half an hour. The
study design will be used as assigning intervention and control group
randomly.The postoperative clinical and imaging evaluation was about 6
months.
3.11
Stages of treatment
1) The patient undergoes routine pre-orthodontic examination, model analysis,
cephalometric measurement, and develops an orthodontic treatment plan.
2) .The patient undergoes routine pre-orthodontic examination, model analysis,
cephalometric measurement, and develops an orthodontic treatment plan.
3) The process of insertion of miniscrew will be depend on the group either
Intervention Group or Control Group. The guide plate will be used for miniscrew
insertion in Intervention Group and experience based on the patient's digital films
for Control Group. The area of insertion of the miniscew will be the upper alveolar
ridge between premolars and molar tooth. The procedure will be performed under
local injection anesthesia.
4) The process of implanting implant nails on Intervention Group is as follows: the
material and model of the implanted micro implant nails are exactly the same as
those of the traditional positioning set. The implant nail diameter is 2mm and the
length is 10 mm. The implant surgery was performed by the same orthodontist in
accordance with recommended operating procedures. Preoperative local anesthesia
will be performed, and micro-implant nails will be implanted at the intended

52
implantation site under the guidance of the guide plate. The area of implantation is
maxillary zygomatic alveolar ridge.
5）The process of implanting implant nails on the Control Group is as follows:
Similar to the intervention group, but the doctor implant the miniscrew based
on experience with CBCT scans.
6) Collect date before and after implant nail implantation.The digital plaster models
will be obtained by scanning with a D700 scanner (3shape, Denmark). Both digital
models and CBCT scan data will be imported into Segma implant guide software
(Beijing, China). The combination method is as follows: first, open the file in a way
that only uses CBCT for implant design and adjust the density of anatomical
landmarks such as the maxillary sinus, condylar foramen, or protrusions to an
explicit level. Then, the teeth or jaw landmark points of the model and CBCT will be
selected to reconstruct a 3D model.
4）The data collection will be performed by obtaining plaster model using intaoral
scanner at T1(immediate post insertion) and T2 (6 months post insertion)
3.12Design and fabrication of guide
The proposed structure will be made of three main components: a tooth guide part, a
gingival guide part, and a steering part. The tooth guide and gingival guide parts are
firmly connected by fracture lines. The mini-implant guide part is specifically
designed to accommodate the angle and position required for miniscrew insertion.
On the basis of the resin guide plate, add a guide hole structure and change it to a
three-quarters circular shape.
During usage, the guide can be pre-designed in accordance with the desired planting

53
position and direction of the patient’s mini-implant, enabling precise guidance during
the implantation process. The designed guide’s data is inputted into EnvisionTEC
Vida 3D printer to create the mini-implant guide. Prior to the implantation of the
mini-screw, patients will be informed about the potential risks and required to sign
an informed consent form. The implantation procedure using the guide involved the
insertion of a 2mm diameter and 13mm length mini-implant (Cibei, Ningbo, China)
(Fig6) into the patient’s
maxillary zygomatic alveolar ridge. Upon completion of
implantation, the guide will be removed.
.
Figure 3.12 A guide with a three-quarters circular hole
3.13 Analyses and measurements:
1. Main efficacy indicators.
A. CBCT analysis indicators: Based on the ideal position of the implant
designed before surgery as the standard, the researcher will measure the linear
deviation of the tip and cap of the TADs in the mesio-distal, buccal-lingual, and
vertical three-dimensional directions, the angle deviation of the tip and cap of the
TADs in the mesio-distal, buccal-lingual, and vertical three-dimensional directions,
the distance between TADs and tooth root and maxillary sinus, and the distance
between two tooth roots.

54
B. Clinical data analysis: The mobility of TADs. ：The stability of a miniscrew
can be evaluated through clinical examination by checking for mobility, and implant
loosening and displacement.
2. Secondary efficacy indicators:
A. CBCT analysis indexes: The thickness of the inner and outer walls of the
maxillary sinus, the root resorption, the thickness of the lingual bone of the TADs,
the thickness of the cancellous bone, the position of the miniscrew, the surrounding
bone density, and any signs of bone loss or inflammation around the screw.
B. Clinical data indicators: Implant diameter, length, gingival type, gingival
color and texture, plaque index, depth of exploration, bleeding index, and symptoms.
Complications will be defined as obvious symptoms, swollen gums,mucous
membranes, clinical mobility of TADs, root resorption, or obvious changes in normal
anatomy around TADs, such as maxillary sinusitis.

55
Figure3.13 digital 3D model
3.Accuracy of miniscrews ：-the linear deviation of the tip and cap of the TADs
in the mesio-distal, buccal-lingual, and vertical three-dimensional directions
-the angle deviation of the head and tail of the TADs in the mesio-distal, buccal-
lingual, and vertical three-dimensional directions
-the distance between TADs and tooth root and maxillary sinus, and the
distance between two tooth roots.
-the thickness of cortical bone and cancellous bone
4.Stability of miniscrews ：-Looseness of mini-implant
5.Safety of miniscrews ：Distant of the root to the miniscrew tip
Distant between miniscrew tip to the maxillary sinus
-the distance between TADs and tooth root and maxillary sinus, and the
distance between two tooth roots.
-the root resorption
3.14Statistical analysis
Two doctors with more than 2 years of clinical CBCT image analysis experience
performed image superimposition and measurement: everyone measured images
once, with a 1-day interval, for a total of 3 measurements, and the average value was

56
taken.The linear deviation of the mini-implant tip and cap and the angular deviation
of the long axis of the mini-implant in the bucco-palatal , mesio-distal and vertical
directions were measured. The results were analysed by the SPSS statistical package
version 19.0(Chicago, USA). The Kruskal–Wallis H test of the multiple independent
samples method was used to compare the three groups of mini-implant᾽deviation in
the three directions.For the values that did not conform to a normal distribution, the
Bonferroni method was used to correct the significance level for pairwise
comparisons. One-way ANOVA was used for values that conformed to a normal
distribution.P value less than 0.05 will be considered significant.
3.15RISK
Compared to the traditional implantation method of implanting miniscrews in
treatment, this experiment will produce 3D guide. Therefore, it is possible to increase
the cost of planting nails
3.16 Sensitivity and interests of the community
Understand and respect the culture, values, and habits of the target community.
Ensure that the research design and implementation process respects these
cultural characteristic
3. 17Ethical review
3.18Compensation
During the treatment process, complications may occur, such as infection at site
of miniscrew insertion, miniscrew loose and dislodge, and also injury to the

57
tooth roots. If the above situation occurs, Department of Stomatology, Xuanwu
Hospital of Traditional Chinese Medicine will bear all the treatment costs of the
patient.
3.19Possible bebefit
This study will benefit individuals where the process of miniscrew implantion is
likely to be safer if patients receive Intervention treatment during miniscrew
implantation.Participants will have material fees waived as a reward.
Chapter 4
DUMMY TABLES
4.1 Annexure A
To compare the accuracy of TADs.
Name: ____________________
Ref. No. ______
The linear deviation of the TADs.
Miniscrew at BP
Miniscrew at MD
Miniscrew at VD
Miniscrew
Cap
Miniscrew
Tip
Miniscrew
Cap
Miniscrew
Tip
Miniscrew
Cap
Miniscrew
Tip

58
BP, bucco-palatal direction; MD, mesio-distal direction; VD, vertical direction.
The angle deviation of the TADs.
Miniscrew at BP
Miniscrew at MD
Miniscrew at VD
Right side
left side
right side
left side
right side
left side
4.2 Annexure B
To compare the safety of TADs.
Name: ____________________
Ref. No. ______
the distance between miniscrew and the tooth root

59
Intervention / Control groups
Distance
x axis
h
Distance
Y axis
Distance
Z axis

60
4.3 Annexure C
To compare the stability of TADs.
Name: ____________________
Ref. No. ______
Date: _________
Months
1
2
3
4
5
6
7
Intervention group
Control group

61
4.4 Gantt chart for research activities
Research Activities
2024
2025
2026
Jan –
Jun
Jul –
Dec
Jan-
Jun
Jul-
Dec
Jan-
Jun
Jul-
Dec
Ethical application and approval
from USM
Data collection
Data analysis and interpretation
Thesis write-up and submission

62
4.5 Milestones and Dates
No.
Details
Estimated Date
1.
Ethical application and approval from USM
May 2024
2.
Data collection
January 2025
3.
Data analysis and interpretation
June 2025
4.
Thesis write-up and submission
January 2026

63
4.6 References
Akyalcin S, Dyer DJ, English JD, Sar C. Comparison of 3-dimensional dental
models from different sources: diagnostic accuracy and surface registration analysis.
Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):831-7.
Bae MJ, Kim JY, Park JT, et al. Accuracy of miniscrew surgical guides assessed
from cone-beam computed tomography and digital models. Am J Orthod Dentofacial
Orthop. 2013;143(6):893-901.
Consolaro A, Romano FL. Reasons for mini-implants failure: choosing installation
site should be valued! Dental Press J Orthod. 2014 Mar-Apr;19(2):18-24.
Cassetta M, Altieri F, Di Giorgio R, Barbato E. Palatal orthodontic miniscrew
insertion using a CAD-CAM surgical guide: description of a technique. Int J Oral
Maxillofac Surg. 2018 Sep;47(9):1195-1198.
Damstra J, Fourie Z, Huddleston Slater JJ, Ren Y. Accuracy of linear measurements
from cone-beam computed tomography-derived surface models of different voxel
sizes. Am J Orthod Dentofacial Orthop. 2010;137(1):16. e1-6; discussion 16 – 7.
Flügge TV, Schlager S, Nelson K, Nahles S, Metzger MC. Precision of intraoral
digital dental impressions with iTero and extraoral digitization with the iTero and a
model scanner. Am J Orthod Dentofacial Orthop. 2013 Sep;144(3):471-8.
Goodarzi Pour D, Romoozi E, Soleimani Shayesteh Y. Accuracy of Cone Beam
Computed Tomography for detection of bone loss. J Dent (Tehran). 2015;12(7):513–
23.
Janson G, Gigliotti MP, Estelita S, Chiqueto K. Influence of miniscrew dental root
proximity on its degree of late stability. Int J Oral Maxillofac Surg. 2013
Apr;42(4):527-34.
Jones Jason P,Elnagar Mohammed H,Perez Daniel E,Temporary Skeletal Anchorage
Techniques.[J] .Oral Maxillofac Surg Clin North Am, 2020, 32: 27-37.

64
Kang Yoon-Goo,Kim Ji-Young,Lee Young-Jun et al. Stability of mini-screws
invading the dental roots and their impact on the paradental tissues in beagles .Angle
Orthod, 2009, 79: 248-255.
Kim SH,Choi YS,Hwang EH,Chung KR, Kook YA, Nelson G.Surgical positioning
of orthodontic mini-implants with guides fabricated on models replicated with cone-
beam computed tomography. Am J Orthod Dentofacial Orthop,2007,131(4
Suppl):S82-S89.
Kuroda S, Yamada K, Deguchi T, Hashimoto T, Kyung HM, Takano-Yamamoto T.
Root proximity is a major factor for screw failure in orthodontic anchorage. Am J
Orthod Dentofacial Orthop. 2007;131(4 Suppl):S68-S73.
Kim J, Heo G, Lagravère MO. Accuracy of laser-scanned models compared to
plaster models and cone-beam computed tomography. Angle Orthod. 2014
May;84(3):443-50.
Kim J, Lagravére MO. Accuracy of Bolton analysis measured in laser scanned digital
models compared with plaster models (gold standard) and cone-beam computer
tomography images. Korean J Orthod. 2016 Jan;46(1):13-9.
Kang Yoon-Goo,Kim Ji-Young,Lee Young-Jun et al. Stability of mini-screws
invading the dental roots and their impact on the paradental tissues in
beagles.[J] .Angle Orthod, 2009, 79: 248-255.
Liou EJ , Chen PH, Wang YC, Lin JC.A computed tomographic image study on the
thickness of the infrazygomaticcrest of the maxilla and its clinical implications for
miniscrew insertion.Am J Orthod Dentofacial Orthop,2007,131(3):352-356
Lim HJ, Choi YJ, Evans CA, Hwang HS. Predictors of initial stability of orthodontic
miniscrew implants. Eur J Orthod. 2011 Oct;33(5):528-32.

65
Lim G, Kim KD, Park W, Jung BY, Pang NS. Endodontic and surgical treatment of
root damage caused by orthodontic miniscrew placement. J Endod. 2013;39(8):1073-
1077.
Liu H, Liu DX, Wang G, Wang CL, Zhao Z. Accuracy of surgical positioning of
orthodontic miniscrews with a computer-aided design and manufacturing template.
Am J Orthod Dentofacial Orthop. 2010;137(6):728.e1-729.
Lo Giudice A, Quinzi V, Ronsivalle V, Martina S, Bennici O, Isola G. Description of
a Digital Work-Flow for CBCT-Guided Construction of Micro-Implant Supported
Maxillary Skeletal Expander. Materials (Basel). 2020;13(8):1815.
Lo Giudice A, Rustico L, Longo M, Oteri G, Papadopoulos MA, Nucera R.
Complications reported with the use of orthodontic miniscrews: a systematic
review. Korean J Orthod. 2021; 51(3):199–216.
Loubele M, Bogaerts R, Van Dijck E, Pauwels R, Vanheusden S, Suetens P, et al.
Comparison between effective radiation dose of CBCT and MSCT scanners for
dentomaxillofacial applications. Eur J Radiol. 2009;71(3):461–8.
Lyu H, Xu L, Ma H, Hou J, Wang X, Wang Y, et al. Accuracy of three-dimensional
periodontal ligament models generated using cone-beam computed tomography at
different resolutions for the assessment of periodontal bone loss. Korean J Orthod.
2023;53(2):77–88.
Miyazawa K, Kawaguchi M, Tabuchi M, Goto S. Accurate pre-surgical
determination for self-drilling miniscrew implant placement using surgical guides
and cone-beam computed tomography. Eur J Orthod. 2010 Dec;32(6):735-40.

66
Ozdemir F, Tozlu M, Germec-Cakan D. Cortical bone thickness of the alveolar
process measured with cone-beam computed tomography in patients with different
facial types. Am J Orthod Dentofacial Orthop. 2013 Feb;143(2):190-6.
Patel, S., Dawood, A., Whaites, E., & Pitt Ford, T. (2009a). New dimensions in
endodontic imaging: part 1-conventional and alternative radiographic systems.
International Endodontic Journal, 42:447-62.
Patel, S. (2009b). New dimensions in endodontic imaging: part 2-cone beam
computed tomography. International Endodontic Journal, 42:463-7 5.
Pithon MM, dos Santos RL. Fabrication of an adjustable mini-screw surgical guide. J
Orthod. 2010;37(2):118-120.
Qiu L, Haruyama N, Suzuki S, et al. Accuracy of orthodontic miniscrew
implantation guided by stereolithographic surgical stent based on cone-beam CT-
derived 3D images. Angle Orthod. 2012;82(2):284-293.
Scarfe, Wc., Farman, Ag., Sukovic, P. (2006). Clinical applications of cone-beam
computed tomography in dental practice. Journal of the Canadian Dental Association,
72(1), 75-80.
Sherrard JF, Rossouw PE, Benson BW, Carrillo R, Buschang PH. Accuracy and
reliability of tooth and root lengths measured on cone-beam computed tomographs.
Am J Orthod Dentofacial Orthop. 2010;137(4 Suppl):100–8.
Spinato S, Bernardello F, Sassatelli P, Zaffe D. Hybrid Implants in Healthy and
Periodontally Compromised Patients: A Preliminary Clinical and Radiographic
Study. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):195-202.
Suzuki EY, Suzuki B. Accuracy of miniscrew implant placement with a 3-
dimensional surgical guide. J Oral Maxillofac Surg. 2008 Jun;66(6):1245-52.

67
Su L, Song H, Huang X. Accuracy of two orthodontic mini-implant templates in the
infrazygomatic crest zone: a prospective cohort study. BMC Oral Health.
2022;22(1):252.
Talaat S, Kaboudan A, Bourauel C, Ragy N, Kula K, Ghoneima A. Validity and
reliability of three-dimensional palatal superimposition of digital dental models. Eur
J Orthod. 2017 Aug 1;39(4):365-370.
Tayman MA, Kamburoğlu K, Küçük Ö, FSÖ A, Günhan M. Comparison of linear
and volumetric measurements obtained from periodontal defects by using cone
beam-CT and micro-CT: an in vitro study. Clin Oral Investig. 2019;23(5):2235–44.
Voss PJ, Steybe D, Fuessinger MA, Semper-Hogg W, Metzger M, Schmelzeisen R,
Poxleitner P. Vascularized scapula and latissimus dorsi flap for CAD/CAM assisted
reconstruction of mandibular defects including the mandibular condyle: technical
report and clinical results. BMC Surg. 2019 Jun 26;19(1):67.
Wang Y, He S, Yu L, Li J, Chen S. Accuracy of volumetric measurement of teeth in
vivo based on cone beam computer tomography. Orthod Craniofac Res. 2011;14(4):
206–12.
Yu JH, Wang YT, Lin CL. Customized surgical template fabrication under
biomechanical consideration by integrating CBCT image, CAD system and finite
element analysis. Dent Mater J. 2018;37(1):6-14.
Ziegler, Cm., Woertche, R., Brief, J., Hassfeld, S. (2002). Clinical indications for
digital volume tomography in oral and maxillofacial surgery. Dentomaxillofacial
Radiology, 31(2), 126-30.

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5. APPENDICES