Evaluating the Effectiveness of 3D Directly Printed Shape Memory Aligners in the Management of Anterior Open Bite
Phase: NA
Conditions: Open Bite
Sponsor: Kufa University

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STUDY PROPOSAL 
 
Evaluating the effectiveness of 3D directly printed 
shape memory aligners in the management of anterior 
open bite in adult patients. 
 
 
 
 
 
Date: 28/Jan/2026 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents: 
TITLE 
PAGE 
Abstract 
4 
1.0 Introduction 
4 
1.1 Background of the study 
4 
1.1.1 Problem statement 
5 
1.1.2 Research gap 
6 
1.2 Study objectives 
6 
1.2.1 General objective 
6 
1.2.2 Specific objective 
7 
1.3 Research questions 
7 
1.4 Research hypothesis 
7 
1.5 Clinical significance of study 
7 
2.0 Literature review 
8 
2.1 Anterior dental open bite 
8 
2.2 Clinical Implications in Open Bite Cases 
9 
2.3 Conventional clear aligner 
9 
2.4 3D direct printed memory shape aligner 
9 
2.5 Properties of 3D-direct printed shape 
memory aligners over conventional aligners 
10 
2.6 CBCT and 3D intraoral scanner 
11 
2.7 Finite element analysis 
11 
3.0 Material and methods 
12 
3.1 Ethical approval 
12 
3.2 Sample size calculation 
13 
3.3 Participants, eligibility criteria, and 
settings 
13 
3.3.1 Interventions 
14 
3.3.2 Interim analysis and stopping guidelines 
16 
3.4 Study design and grouping 
16 
3.6 Digital impression-taking technique and 
appliance fabrication 
16 
3.6.1 Thermoforming on the 3D-printed 
models 
16 
3.6.2 Direct 3D printing shape memory 
aligners 
17 
3.7 Finite Element Analysis (FEA) 
18 
3.8 Clinical trial 
21 
3.8.1 Randomisation and Blinding 
21 
3.8.2 Outcome measurement 
21 
3.8.2.1 Processing and data collection 
(cephalometric tracing) 
21 
3.8.2.2 Measurement variable outcomes will 
be as follows 
22 

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4.0 Statistical analysis 
23 
4.1 Intra-examiner and inter-examiner 
reliability 
24 
5.0 References 
28 
6.0 Appendices 
34 

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Abstract 
Conventional clear aligners (CA) have emerged as a popular alternative due to their 
advantages over fixed appliances in the treatment of anterior dental open bite. Open bite cases 
require controlled vertical movements, which are difficult to manage with traditional aligners. The 
3D-direct printing has advantages over conventional aligners (continuous force, high-precision fit, 
and high vertical control). Graphy, a South Korean company, offers the world's first direct 3D-
printed clear aligner made from shape memory photopolymer. This study will investigate the 
efficiency of 3D-printed shape memory clear aligners in treating anterior dental open bite (AOB) 
in adult patients. The finite element analysis will proceed before the clinical trial and 
standardisation to establish common procedures for model creation. Three models will be designed 
as follows: Model 1: no composite attachment with 3D direct-printed shape memory aligner. 
Model 2: attachment with 3D direct-printed shape memory aligner. Model 3: attachment with 
conventional clear aligner. The clinical trial will be a multicentre randomised clinical trial with 
three parallel arms for Iraqi adult patients with anterior dental open bite (18-35 y.) according to the 
study criteria. Three groups of participants will be tested: Group I (conventional aligner with 
attachment), Group II (3D shape memory aligner without attachment), and Group III (3D shape 
memory with attachment). All patients will receive the same treatment and sign informed consent 
to participate. Outcome measurement will be recorded before the treatment (T0) and reported after 
the first series of aligners (15-20 aligners) (T1). Cephalometric analysis (from the CBCT DICOM 
file) will be performed using Dolphin Imaging™ software, which will be used to identify and 
approximate landmarks in the spatial space. The study will also include measurements of dental 
and skeletal leaners and angular changes. SPSS Statistics (Shapiro-Wilk and Kolmogorov-
Smirnov tests, ANOVA, a paired T-test and Tukey's Honestly) will be used to gather numerical and 
inferential data from finite element analysis tests and clinical trials and will compare patient-
reported outcome measures. The expected general outcome will provide a satisfactory outcome of 
3D shape memory aligner in the treatment of anterior open bite without the need for attachment in 
a highly comfortable way for the patients.  
1.0 Introduction 
1.1 Background of the study: 
Anterior open bite (AOB) is a malocclusion of the maxillary and mandibular incisors when 
they do not overlap vertically, with varying degrees of severity. This malocclusion adversely 
affects an individual’s quality of life by hindering and impairing essential oral functions (1). The 
aetiology of an AOB is multifactorial in nature. Unfavourable growth patterns, oral habits, 
respiratory factors, and neuromuscular imbalances have been suggested to play a role. AOB results 
in significant aesthetic and functional concerns often (2). Managing AOB poses challenges in 
diagnosis and treatment planning due to its multifactorial aetiology and high propensity to relapse, 
as vertical growth is the last to cease (3). Open bites are classified as mild (2 mm), moderate (3-4 
mm) and severe (higher than 4 mm) (4). Traditionally, fixed appliances have been the mainstay of 
treatment for such malocclusions, often requiring the use of auxiliaries such as mini-screws and 
occlusal bite blocks to achieve desired outcomes (5). In recent years, conventional clear aligners 
(CA) have emerged as a popular alternative to traditional fixed appliances due to many advantages 
(e.g., posterior intrusion and the "bite block" effect, aesthetics and discretion, improved oral 
hygiene and patient comfort). Clear aligners are used to treat a variety of orthodontic conditions, 

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especially those considered mild to moderate (e.g., correction of crowding and spacing, overbites, 
and crossbites) (6). Clear aligners are fabricated from a variety of thermoplastic polymeric 
materials. These materials are heated and then vacuum- or pressure-formed over a 3D-printed 
model of the patient's teeth (e.g., Polyethylene Terephthalate Glycol (PETG), Thermoplastic 
Polyurethanes (TPU)). Early clear aligners were limited because they were less effective at 
achieving complex movements, especially those that involve extruding (pulling out) anterior teeth 
or intruding (pushing in) posterior teeth—both of which are key for correcting an AOB. This was 
primarily due to the simple plastic material and a lack of additional features to control force 
application (7). With recent advances in clear aligner therapy, improved materials, attachment 
techniques and digital treatment planning, the potential for non-invasive treatment has increased. 
The orthodontic treatment of anterior open bite aims to guide the extrusion of the upper and lower 
incisors and the molar intrusion to achieve a positive overbite. Also, the lower molar intrusion 
leads to anticlockwise mandibular rotation (8). The decision for posterior intrusion or upper incisor 
extrusion is made following a smile analysis and the evaluation of the facial lower-third type. 
Attachments are required for the anterior extrusion (9).  
3D-direct printing has advantages when compared to conventional clear thermoformed techniques, 
including (a) manufacturing speed, (b) improved patient fit, and (c) less invasive modelling 
techniques (10). Graphy, a South Korean company, offers the world’s first direct 3D-printed clear 
aligner made from shape memory photopolymer Tera Harz (TC-85) (11). This resin enables 
aligners to hold a programmed shape and recover if deformed and provides a transformative 
upgrade over traditional aligners by combining the following advantages: (i) continuous force, (ii) 
high-precision fit (figure 1.1), (iii) lower stage count, (iv) improved comfort, and (v) aesthetic 
clarity (12). These advantages are especially meaningful for open bite treatment, where vertical 
control and predictable biomechanics matter most. However, their design and the primary 
mechanisms of action for clear aligners involve incisor extrusion and tipping (13). Therefore, this 
study aimed to evaluate the efficacy of 3D direct-printed shape memory aligners for treating AOB.   
1.1.1 Problem statement  
AOB correction requires controlled vertical movements (extrusion of anterior teeth and 
intrusion of posterior ones), while the most popular conventional clear aligners struggle to achieve 
these movements reliably due to unpredictable force decay and limited control of vertical 
biomechanics. Yet, results show variability in the underlying mechanisms, with the exact method 
of correction remaining debatable. Moreover, the conventional clear aligner has low adaptability 
in comparison with the 3D direct-printed aligner. Figure(1.1). 
In this study, we have conducted an electronic search in many engines, such as Google Scholar, 
Semantic Scholar, Scopus, ResearchGate, PubMed Medline, ScienceDirect, NCBI, PubMed 
Central, PubMed Search and Cochrane Library. There wasn’t any conducted research using 3D 
direct-printed shape memory clear aligners in the treatment of open bite cases in adult patients, 
and even evidence for conventional aligners in open bite management is limited, especially in 
high-quality trials.  
 

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1.1.2 Research gap: 
Despite recent advances in clear aligner therapy, there is limited high-quality evidence on 
their effectiveness in managing anterior open bite (AOB) in adults. Moreover, no studies have 
evaluated the clinical or biomechanical performance of 3D direct-printed shape memory aligners 
for AOB correction, highlighting a critical need for comparative research to establish the 3D 
printed shape memory aligners potential advantages over conventional thermoformed aligners. 
 
Figure 1.1: Adaptation of a 3D direct-printed memory shape aligner to that of conventional 
aligners. 
1.2 Study objectives: 
1.2.1 General objective: 
The general objective of this study to investigate of 3D-printed shape memory aligners in 
the treatment of anterior dental open bite adult patients.  
1.2.2 Specific objective: 

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1. Investigate 3D direct-printed shape memory aligners for potential AOB correction with and 
without extrusion attachments. 
2. Investigate and compare the amount of stress distribution and initial teeth displacement applied 
by conventional clear aligners and 3D direct-printed shape memory aligners during treatment. 
3. Investigate and compare the effect of the 3D-printed shape memory aligner (with or without 
extrusion attachment) and the conventional clear aligner on dental (molar intrusion and incisor 
extrusion and angulation) changes and patients’ satisfactory outcomes. 
1.3 Research questions: 
1. Do 3D-direct-printed shape memory aligners demonstrate potentiality in the management of 
AOB?  
2. What is the effect of 3D-direct printed shape memory aligners on molar intrusion?  
3. Can the 3D-direct printed shape memory aligners extrude anterior teeth without the use of 
attachments? 
4. Do 3D-direct printed shape memory aligners generate greater/higher stress distribution and 
initial teeth displacement compared to conventional clear aligners? 
1.4 Research hypothesis: 
1. 3D direct-printed shape memory aligners provide a clinically significant improvement in the 
correction of anterior open bite (AOB) compared to conventional clear aligners.  
2. The 3D-direct printed shape memory aligner has better stress distribution and initial teeth 
displacement than conventional clear aligners in the treatment of anterior dental open bite cases. 
3. 3D direct-printed shape memory aligners can produce effective anterior tooth extrusion without 
the incorporation of attachments. 
4. The 3D-direct printed memory shape aligner can intrude the posterior upper and lower molars. 
1.5 Clinical significance of study: 
1. Using a 3D direct-printed shape memory clear aligner (Graphy TC-85) has a clinical 
significance: 
a. Easier to use and faster chairside production (14). 
b. Lower cost (15). 
c. Less force (16). 
d. No attachments (more comfort and aesthetics) (17). 
e. Eliminates the need for models’ storage (18).  

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2. Well understanding and discovering the strong and weak points in the biomechanical effects of 
both conventional and 3D-printed shape memory aligners in the treatment of anterior dental open 
bite cases. 
3. Understanding the stress distribution and initial displacement during teeth movement when 
using conventional and 3D-direct printed memory shape aligners. 
2.0 Literature review 
2.1 Anterior dental open bite: 
Anterior open bites (AOBs), characterised by the absence of contact between the anterior 
teeth, represent a complex treatment challenge. Consequently, a precise diagnosis is imperative for 
formulating a treatment plan. Correa et al. (19) reported a global prevalence of 4.83% for anterior 
open bites in individuals with permanent dentition. The aetiology of an AOB can be classified as 
hereditary or non-hereditary. In hereditary cases, it may be purely inherited from one of the parents. 
Non-hereditary causes encompass non-nutritive sucking (such as finger or pacifier habits), 
abnormal tongue function, neurological disorders, mandibular condyle pathology, and iatrogenic 
factors (20). Dental AOB is characterised by a normal craniofacial pattern with proclined and 
under-erupted anterior teeth. Skeletal AOB is marked by specific anatomical characteristics, 
including an overlarge mandibular plane angle, gonial angle, anterior facial height, and total facial 
height, as well as an anteriorly upward-tilting palatal plane and a retrognathic mandible. Functional 
AOB is closely associated with the behaviour of the head and neck muscles during speaking, 
breathing, chewing, and swallowing. The equilibrium of the dentition can be affected by 
imbalances in the orofacial muscular system, particularly by abnormalities in the tongue, lips, and 
cheeks (21). Treatment options for correcting anterior open bites in permanent dentition include 
conventional fixed appliances or orthodontic surgical orthognathic treatment. With technological 
advancements, an alternative therapeutic option emerged in the 1990s: invisible aligners (22). 
These aligners are designed using computer technology to correct dental positions and have gained 
popularity among adult patients due to their aesthetics and comfort. Studies suggest potential molar 
intrusion attributed to the coverage provided by the aligner material, which can enhance control 
over the vertical dimension, making it a viable option for anterior open bite treatment (23). 
Aligners are composed of a plastic material, potentially consisting of polyethylene terephthalate 
glycol, polyvinyl chloride, or polyethylene terephthalate, among other materials. Orthodontic 
materials are subject to continual evolution, thereby enhancing mechanical properties and 
consequently impacting treatment outcomes. This treatment promotes three-dimensional force 
distribution across the entire contact surface (24). Dental movement is realised by a disparity 
between the device and the geometric configuration of the teeth, as predetermined in the treatment 
plan. Presently, aligner treatment is executed utilising software that simulates tooth movement and 
fabricates the devices via CAD-CAM (computer-aided design-computer-aided manufacturing) 
technology (25). This system integrates interactive planning using 3D computational technology, 
3D movement within CAD-CAM, and the digital design/manufacturing of the device. 
Additionally, it defines the positioning of attachments, affixed with composite resin, tailored for 

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intricate tasks across all spatial planes. With such precision, it becomes feasible to delineate a 
treatment plan aimed at correcting complex issues like an anterior dental open bite (26). 
2.2 Clinical Implications in Open Bite Cases: 
Open bite correction often relies on (27): 
• 
Posterior intrusion (to allow anterior closure). 
• 
Anterior extrusion (to reduce the open bite). 
• 
Vertical control, which is difficult with CCAs (conventional clear aligners) due to less 
effective vertical forces. 
2.3 Conventional clear aligner (made from thermoformed plastics (e.g., PETG, polyurethane)): 
Open bite correction with clear aligners provides adult patients with a quicker and more 
aesthetic treatment alternative (28). Literature has reported that open bite correction via clear 
aligners facilitates a better mechanical advantage due to additional occlusal coverage. This 
provides better vertical dimension control when compared with traditional braces, a removable 
clear aligner system as an alternative to fixed orthodontic treatment (29). Clinicians have reported 
that aligners help deepen the dental overbite during orthodontic tooth movement. Therefore, 
aligners can possibly be used as an effective modality to treat patients with anterior open bite (30).  
Harris et al. (31) found that most anterior open bite correction during clear aligner treatment 
occurred due to anterior tooth extrusion rather than posterior intrusion. However, a 2009 study by 
Kravitz et al. found that extrusion is the least accurate type of tooth movement during clear aligner 
treatment, with only 29.6% accuracy (32). Rossini et al. also reported extrusion as being a difficult 
movement with clear aligners with a 30% accuracy (33). Another recent systematic review found 
that one of the limitations of clear aligner treatment is effective and predictable extrusion of 
maxillary incisors (34). 
One solution to increase the effectiveness of difficult tooth movements, such as incisor extrusion, 
is to incorporate attachments or composite projections on certain tooth surfaces (35). A study by 
Karras et al. (36) found that adding attachments on certain teeth increased the accuracy of 
achieved-to-predicted movements. When it comes to attachments. Conventional attachments are 
standardised in shape and size and can be selected from a wide attachment library.  
2.4 3D direct printed memory shape aligner (Graphy – typically made from advanced 
materials like TC-85 shape memory polymers (SMPs)): 
With extensive digital technological advancements, 3D printers have evolved in parallel, 
allowing the printing of various resin materials. With 3D printers becoming more advanced, 
cheaper, and more compact, the concept of in-office aligner production gained popularity. The 
ability to print aligners directly without the need for a dental model printing step could be the next 
big step in the aligner treatment revolution (37). This major achievement was made by Graphy 
(Seoul, Korea), a Korean-based company that introduced in 2019 a resin material called TC-85 
DAC as the first aligner resin for direct aligner printing, followed by the new resin material TA-
25 for aligner printing (38). The era of printed aligners has just begun in the orthodontic field, so 

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evidence-based studies are limited. Studies on material mechanical properties, surface roughness, 
cytotoxicity, estrogenicity, leaching, and fitting accuracy are required. Furthermore, comparison 
of printed aligners with thermoformed ones must be studied extensively (39). 3D-printed aligners 
could be the next paradigm shift in orthodontic treatment. 3D printing via photopolymerisation 
from clear resins seems to be a promising option, as the specific characteristics and requirements 
of the material properties are more appropriate (40). Although diverse materials are present in the 
market, not one 3D printable material currently available commercially meets the standards of 
biocompatibility, translucency, and appropriate mechanical properties. The only exception is Tera 
Harz TC-85 (Graphy, Seoul, South Korea), which, according to the company website, has been 
approved by multiple international agencies, including the Korea Food and Drug Administration, 
European Commission, and U.S. Food and Drug Administration (41).  
2.5 Properties of 3D-direct printed shape memory aligners over conventional aligners: 
a. True Shape Memory Mechanics: 
• 
The aligner can be briefly softened in warm/hot water (up to ~100°C for 1–2 minutes), then 
regain its original printed shape, restoring its corrective force and fit (42).  
• 
This reduces force decay and deformation, allowing one aligner stage to replace two to 
three traditional ones (42). 
b. Continuous, Gentle Force 
• 
At body temperature (~30–40°C), the aligner gradually returns to its programmed form, 
applying light but persistent force, ideal for vertical movements like anterior intrusion or 
posterior extrusion in open bite treatment (43).  
c. Direct 3D Printing for Precision 
• 
The aligner is printed directly from the patient’s digital scan—with no thermoformed 
models—resulting in a near-perfect fit, accurate engagement of undercuts, and precise 
force application (44). 
• 
Flexible thickness zones can be incorporated to fine-tune biomechanics per case (44). 
d. No Attachments Needed 
• 
Graphy’s aligners often avoid bonded attachments altogether, even in complex movements 
like rotations or extraction cases, thanks to shape memory action and integrated design 
features (bite blocks, pressure spots, etc.). (45).  
e. Improved Comfort & Hygiene 
• 
Softened in warm water before insertion, the aligner is easier to seat—even in crowded or 
tight cases—minimising insertion/removal discomfort (46). 

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• 
Being scratch-resistant and heat-tolerant, the material can be brushed and disinfected 
reliably, maintaining transparency and hygiene (46). 
f. 3D printing enables precise, patient-specific designs, which is critical in open bite 
treatment: 
• 
Variable thickness control: 3D printing allows the aligner to have areas of different 
stiffness or flexibility to target specific teeth more effectively (47). 
• 
Embedded force programming: SMPs can be pre-stressed during printing to deliver 
specific forces once in the mouth (47). 
• 
Improved fit and engagement: More accurate printing can create better tooth contact and 
retention, which is crucial in vertical corrections (48). 
2.6 CBCT and 3D intraoral scanner: 
CBCT (Cone Beam Computed Tomography), is a type of X-ray imaging that produces 
high-resolution, three-dimensional images of teeth, jaws, and other hard tissues in the head and 
neck. Unlike traditional X-rays, CBCT uses a cone-shaped X-ray beam to capture a full 360-
degree rotation around the patient, which is then processed by a computer to create a 3D model. 
This advanced imaging technique offers detailed anatomical views with lower radiation 
exposure compared to traditional CT scans, making it invaluable in fields like dental surgery 
and orthodontics (47). 3D dental scanners create highly accurate digital replicas of a patient's 
mouth, teeth, and gums, eliminating the need for traditional, messy physical impressions. The 
technology significantly improves speed, accuracy, and patient comfort across various dental 
procedures. There are two primary types of scanners: intraoral scanners used directly in the 
mouth and laboratory scanners for models and impressions (48). 
2.7 Finite element analysis: 
Finite element analysis (FEA) was initially introduced by Turner et al. (49) in 1956. The 
FEA is a computer-based numerical method used to simulate complex geometrical objects and 
their physical properties. The FEA is a non-invasive and accurate method that provides useful 
data for an orthodontist to understand the biomechanical and physiological responses that 
occur in tissues such as the periodontal ligament and the alveolar bone (50). Previous FEA 
studies on clear aligners found that composite attachments played an important role in precise 
tooth movement with a clear aligner (49).  
Usage in clear aligner studies: 
o Simulates how aligners exert forces on teeth (especially anterior extrusion) (50). 
Figure (2.1) 
o Evaluates stress distribution in periodontal ligament (PDL), bone, and aligner (50). 
Figure (2.2). 
• 
Advantages: 
o Non-invasive and allows detailed 3D analysis (51). 

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Figure 2-1: Resultant values of initial teeth displacement: (a) no composite attachment, (b) rectangular 
beveled attachment. 
 
Figure 2-2: Distribution of the average normal stress at the upper anterior teeth PDL: (a) no composite 
attachment, (b) rectangular beveled attachment. 
3.0 Material and methods 
3.1 Ethical approval 
Ethical clearance will be obtained from the Medical Ethics Committee, Faculty of 
Medicine, University of Kufa, Iraq (MEC-163). This randomised clinical trial will be registered 
and reported at clinicaltrials.gov, among Class I molars and skeletal relationships with anterior 
dental open bite Iraqi patients. 
 

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3.2 Sample size calculation: 
Sample size calculations were performed. In each group, a sample size will be calculated 
by G-power (version 3.1), at a power of 80% and a 0.05 level of significance, which enabled 
the detection of significance between the three treatment groups in overbite changes of 1.5 mm 
with a standard deviation of 1.5. The final anterior open bite sample consisted of 15 patients for 
each group. To account for a potential 10% dropout rate, two individuals will be added to each 
group, resulting in a final sample size of 51 individuals—17 per group, according to a previous 
study done by Serdar et al. (52). 
3.3 Participants, eligibility criteria, and settings: 
Patients will be recruited from the Department of P.O.P., University of Kufa, Azadi Dental 
Centre, and a private dental clinic located in Iraq. The treatment will be done by a specialist 
orthodontist. Patients will be recruited at the time of their consultation if they meet the study 
criteria: Table (3.1). 
Table 3.1: Study criteria. 
The inclusion criteria: 
The exclusion criteria: 
 
(1) Adult patients, age 18–35 years, all teeth 
present and fully erupted (excluding third molars) 
Adults have completed craniofacial growth, which 
makes orthodontic movements more predictable 
and stable; Adults are typically more motivated and 
compliant with the 20–22 hours/day wear time, 
essential for treatment success (not forgetting to 
wear them, reducing effectiveness). Moreover, in 
mixed dentition there will be teeth eruption and 
exfoliation that could be effect on the aligner fitting 
and accuracy] (53,54). 
(2) Mild-moderate dental anterior open bite (-1 to 
3 mm vertical gap between the incisal edge of 
upper and lower incisors).  
(3) Angle Class I molar relationship.  
(4) Skeletal Class I (ANB 3±2°).  
(5) Average (normodivergent) vertical dimension 
(MMPA 27±5°). 
(6) Healthy periodontal status.  
(1) Moderate to severe crowding.  
(2) Loss of posterior teeth.  
(3) History of trauma to the molars or incisors.  
(4) History of endodontic treatment to the 
maxillary first molar or incisors. 
(5) Systemic disease related to bone metabolism. 
(6) Taking immunosuppressive drugs or drugs 
inhibiting or accelerating tooth movement; and  
(7) Neuromuscular deficiencies. 
(8) Skeletal open bite. 
(9) Short upper lip. 
(10) Average or increased incisors show. 
(11) treatment plan requiring surgery or extraction 
of any maxillary teeth. 

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(7) Well-aligned or mildly crowded dentition. 
(8) Patients should be treated with incisor extrusion 
(upper only or both). 
 
(12) severely rotated or heavily restored (direct or 
indirect restoration) maxillary anterior teeth  
3.3.1 Interventions: 
All patients will be received the same treatment and will be a signed informed consent to 
participate in the study. The patient intervention will be summarized as following timeline flow 
chart: (Figure 3.1). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3.1: Patient intervention timeline flow chart. 
 
Before aligner insertion (T0) 
a. Open bite measurement 
b. CBCT records 
c. Intraoral scanner 
Aligner and attachment setting  
a. Attachment bonding 
b. Composite attachment position 
c. Aligner insertion 
d. Aligner wearing time 
e. Movement limit 
After the first series of aligners 
(15-20 aligners) (T1) 
a. Open bite measurement 
b. CBCT records 
c. Intraoral scanner 
 

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1. Before aligner insertion (T0): 
a. Open bite measurement: Will use digital software (3Shape OrthoAnalyzer) from the incisor’s 
edges of upper and lower central incisors, also; clinically using digital clipper (Kroeplin 
Caliper, Germany) (54). 
b. CBCT records: CBCT radiography will be done for each patient after signing the informed 
consent. All the patients will take a CBCT (T0) (80 kV, 5 mA, 9.2 s exposure time, 0.125 mm 
voxel resolution, 80 x 80 mm field of view; Veraviewepocs J Morita MPG, Fushimi, Kyoto, 
Japan). CBCT images will be reconstructed every 0.125 mm. One Volume Viewer Software 
(Version 11.0, J Morita, Chatsworth, CA, USA) will be taken before treatment (T0) and after 
the first series of aligners (15-20 aligners) (T1). 
c. Intraoral scanner: An intraoral scanner (TRIOS, 3Shape, Copenhagen, Denmark) will be used 
to scan the upper and lower jaws with occlusion, also to render an STL file, which will be 
imported to the 3Shape OrthoAnalyzer (USA), that will be used to design each patient’s 
treatment sequence and will be taken before (T0) treatment. 
2. Aligner and attachment setting: 
a. Attachment bonding: The protocol for attachment bonding was standardised using the 
commonly accepted bonding procedures. Attachments and IPR were tailored to each patient’s 
needs, based on each of the three practitioners’ clinical experience. Therefore, attachment 
location and IPR on teeth cannot be reported systematically.  
b. Composite attachment position: The incisal margin of the composite attachments will be 
placed 3.5 mm gingivally to the incisal edge. Both mesial and distal margins of the composite 
attachments were 2.5 mm away from the mesial and distal surfaces of the tooth and will be 
designed to be 4 mm wide mesiodistally; the incisogingival dimension and the angulation were 
unaltered (55). 
c. Aligner insertion: Proper demonstration of aligner insertion as instructed will be observed. 
Participants will verbally confirm compliance at each appointment, and compliance will be self-
recorded by participants in hours per day. 
d. Aligner wearing time: Patients will be instructed to wear each aligner for a minimum of 22 
h/d, 7 d/wk each, before moving to the next aligner, the standard aligner protocol used by the 
participating providers (55). 
e. Movement limit: The movement (extrusion) limit will be set to 0.25 mm maximum per 
aligner (55). 
3. After the first series of aligners (15-20 aligners) (T1): 

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All the records that have been taken before treatment (open bite measurement, CBCT (T1), 
intraoral scanner) will be taken after the first series of aligners (15-20 aligners by the same 
criteria as before treatment.  
3.3.2 Interim analysis and stopping guidelines: 
Participants will be informed that they could discontinue participation at any time and that 
it would not affect their remaining treatment. Patients with poor tracking requiring midcourse 
intervention or failure to complete the aligners prescribed will be noted for reporting purposes 
but not included in the final analysis. 
3.4 Study design and grouping: 
The study design will be a multicentre randomised clinical trial with three parallel arms.  
Three groups of participants with different treatments will be tested in the present study 
as follows: 
Group I: Patients treated with conventional clear aligners with attachments [rectangular-
shaped attachments with bevelled edges toward the gingiva on anterior upper and lower teeth 
(53)].  
Group II: Patients treated with 3D direct-printed shape-memory aligner without attachment, 
and  
Group III: Patients treated with 3D direct-printed shape memory clear aligners with 
attachments [rectangular-shaped attachments with bevelled edges toward the gingiva on 
anterior upper and lower teeth (53)].  
3.5 Treatment duration: 
The treatment duration for each patient will be about 8-14 months, and the general study 
time will take about 3 years to complete. 
3.6 Digital impression-taking technique and appliance fabrication: 
3.6.1 Thermoforming on the 3D-printed models: 
The conventional thermoforming technique is indirect in nature. After treatment 
planning, sequential dental models representing the patient’s treatment progress will be printed 
after digital impression scanning of the upper and lower jaws and taking occlusion using an 
intraoral digital scanner (Trios, 3Shape, Copenhagen, Denmark); the thermally manipulated 
transparent plastic sheets (Tristar, 0.75 mm thickness, Australia) will be moulded against each 
dental model (3shape orthoanalyser, 1.9 software, Denmark-LINIZ printer, Seoul, Korea) by a 
pressure- or vacuum-forming machine (BioStar, Germany) for aligner production. The retrieved 
aligners will be trimmed and finished for patient delivery and insertion (Figure 3.2).  

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Figure 3.2 : schematic diagram of the laboratory technique to fabricate the conventional 
thermoformed clear aligner. 
3.6.2 Direct 3D printing shape memory aligners: 
The direct 3D printing technique designs and fabricates the aligner directly using 
biocompatible clear resins (Tera Harz TC-85 (Graphy, Seoul, South Korea)) without requiring a 
dental model. The digital orthodontic workflow of 3D-printed aligners The sequential steps 
encompassing the process of direct 3D-printed clear aligner manufacturing are: (i) data 
acquisition using intraoral digital scanning (Trios, 3Shape, Copenhagen, Denmark), (ii) virtual 
planning (3D models) and computer-aided designing of clear aligners (3shape orthoanalyser, 1.9 
software, Denmark), (iii) 3D printing (LINIZ, developed by Graphy 0.75 mm thickness, Inc., 
Seoul, Korea), and (iv) post-processing (cleaning the uncured residual resin, support removal, 
and post-production curing; for the Tera Harz TC-85 aligners, recommendations mention the 
process of cleaning by centrifugation (Tera Harz Spinner developed by Graphy, Inc., Seoul, 
Korea) for around 3–4 min or removal with a soft scraper). This will be followed by support 
removal and post-production curing with Cure M (Graphy, Seoul, Korea). The nitrogen 
generation curing unit (Tera Harz cure developed by Graphy, Inc., Seoul, Korea) will be utilised 
and recommended to enhance the physical properties of the resin material by providing an inert 
environment, thereby preventing the formation of an oxygen inhibition layer. The THC 2 UV 
Curing system (Graphy Inc., Seoul, Korea) is a known representation of this category. For the 
Dental LT-clear resin aligners, washing by ultrasonication with isopropyl alcohol (96/99%) and 
postproduction curing with the Form Cure unit (Formlabs, Somerville, Mass., USA) (24, 34, 38) 
are undertaken (Figure 3.3).  

18 
 
 
Figure 3.3: schematic diagram of the laboratory technique to fabricate the 3D-direct printed 
memory shape aligner 
3.7 Finite Element Analysis (FEA): 
The workflow chart to obtain results of finite element analysis (Figure 3.4): 
 
Figure (3.4): schematic diagram of the workflow chart to obtain results of finite element 
analysis. 
This study will be approved by the Medical Ethics Committee, Faculty of Medicine, University of 
Kufa, Iraq (MEC-163). A 3D geometric model will be prepared of a maxilla arch that includes the 
maxilla, periodontal ligament (PDL), upper teeth with the upper right central incisor intruded, clear 

19 
 
aligners, and composite attachments (Figure 3.5a). The maxilla and upper teeth will be constructed 
from cone-beam computed tomography (CBCT) data of a patient who had an Angle Class I skeletal 
relationship with well-aligned teeth and normal tooth shape. The CBCT image will be taken with 
a 3D Accuitomo 170 (J. Morita Mfg. Corp., Kyoto, Japan) using an FOV of 170 mm × 120 mm 
and a voxel size of 0.25 mm. The image will be imported into ITK-SNAP software (51) to generate 
the 3D geometric model with a high-resolution FE model for simulations. The PDL will be 
modelled on the root shape with a thickness of 0.25 mm (52). A rectangular bevelled shape of 
composite attachments (Figure 3.6) will be constructed on the upper right central incisor with the 
shape derived from the Invisalign® system (53). Specifically, the incisal margin of the composite 
attachments will be placed 3.5 mm gingivally to the incisal edge (54). Both mesial and distal 
margins of the composite attachments were 2.5 mm away from the mesial and distal surfaces of 
the tooth, respectively. The clear aligners (conventional and 3D direct-printed clear aligners) will 
be made based on the target dentition to perform upper central incisor extrusion. Target dentition 
will be developed by extrusion of the upper right central incisor and composite attachment with a 
0.15 mm displacement along the tooth axis (55). After that, the clear aligners will develop from an 
external offset of all teeth crowns and attachments at the target dentition. Clear aligner thickness 
was set at 0.75 mm with a scalloped trimline margin, precisely following the gingival contour of 
the teeth (56). To minimise the effect of upper incisor angulation on experimental outcomes, 
maxillary central incisors were adjusted to a 90° orientation during reconstruction.  
Finally, three models will be designed as follows: 
Model 1: no composite attachment with 3D direct-printed shape memory clear aligner. 
Model 2: rectangular bevelled attachment with 3D direct-printed shape memory clear aligner. 
Model 3: rectangular bevelled attachment with conventional clear aligner. 
The meshing process will produce a total of 1,467,263 nodes and 5,338,190 elements in a model 
without a composite attachment and 1,472,483 nodes and 5,355,482 elements in a model with a 
rectangular bevelled attachment (Figure 3.5b). Bonded contacts will be set at the interfaces 
between the bone and PDL, PDL and teeth, and teeth and composite attachment. Surface-to-surface 
contact will be used between the clear aligner and teeth as well as the clear aligner and the 
composite attachment. Fixed supports were applied on the upper part of the maxilla. A friction 
coefficient of µ = 0.2 was used between the aligner and teeth as well as the aligner and the 
composite attachment. Table (3.2) shows the material properties and mesh size that will be used in 
this study (Jedliński et al. (53)). The finite element analysis will proceed before the clinical trial 
according to the selection criteria and standardisation to establish common procedures for model 
creation, data exchange, and validation to ensure model quality, reliability, and consistency across 
different software and users. 
 
 
 

20 
 
Table 3.2: Material properties and mesh size. 
 
 
Figure 3.5: Maxilla model with PDL, upper teeth, clear aligner, and composite attachment: (a) 
3D model and (b) finite element meshing models. 
 
Figure 3.6: Dimensions of the rectangular beveled attachment. 
An anatomical coordinate system will be established by defining the occlusal plane using reference 
points at the incisal edges of central incisors and the mesiobuccal cusp tips of first molars. The X-
axis (coronal plane) will be orientated positively toward the mesial aspect, the Y-axis (sagittal 
plane) positively toward the lingual aspect, and the Z-axis (vertical plane) positively toward the 
gingival direction. Sequential and simultaneous extrusion movements of maxillary central incisor 
teeth will be simulated. Clear aligners will be applied with an extrusive force corresponding to a 
displacement of 0.15 mm along the long axis of the teeth. Reaction forces resulting from each 
extrusive method will be calculated using ITK-SNAP software after applying the preset 
displacement of 0.15 mm to the aligners (56). Forces equal in magnitude to these reaction forces 
will then be applied to the corresponding teeth to evaluate initial displacement and PDL stress 
distribution. 
Therefore, this study will aim to evaluate the initial tooth displacement and stress distribution 
generated during central incisor extrusion with conventional clear aligners (with attachments) and 
3D direct printed shape memory aligners (with and without attachments).  
 
 

21 
 
3.8 Clinical trial 
3.8.1 Randomisation and Blinding: 
The randomisation sequence will be generated using randomisation software (sealed 
envelope) with a 1:1:1 allocation ratio using block randomisation. The allocation sequence will be 
concealed from the investigator with sequentially numbered, opaque, and sealed envelopes. 
Operator and subject blinding will not be possible due to the nature of the intervention. The data 
will be coded and presented to the blinded evaluator. All subjects will be randomised into 
conventional and 3D direct-printed shape memory aligner groups (with or without attachment). 
All data will be collected at two time points: pretreatment (T0) and after the treatment (the first 
series of aligners (15-20 aligners) (T1)). The dental and skeletal changes were recorded by lateral 
cephalograms (Dolphin software, USA). Maxillary first molar intrusion will be recorded by cone-
beam computed tomography (CBCT), and force distribution and initial tooth displacement will be 
recorded by a finite element analysis program.  
3.8.2 Outcome measurement: 
Outcomes and any changes after trial commencement, midcourse interventions to improve 
tracking, such as rescanning or introducing auxiliary appliances, will be recorded and reported, 
but the teeth involved will not be analysed as part of the corresponding group. Maxillary and/or 
mandibular incisors not tracking, noted by a minimum of 1 mm of aligner material incisally when 
the aligner was fully seated, will be recorded and reported but not analysed within the group 
assigned (56). Patients will be evaluated only after the first series of aligners (15-20 aligners (T1)). 
After that, treatment proceeded as necessary, determined by patients and individual practitioners, 
and was not recorded (57). Maxillary and mandibular arches will be evaluated in this study.  
3.8.2.1 Processing and data collection (cephalometric tracing):  
DICOM (Digital Imaging and Communications in Medicine) files will be reoriented to 
standardise head position and converted into Nearly Raw Raster Data (NRRD) format using ITK-
SNAP software, version 3.8.0 (University of Pennsylvania, https://www.itksnap.org). The 
converted files will be uploaded to 3D Slicer software, version 5.2.2 (https://www.slicer.org/), an 
open-source 3D medical image viewing software. 3D models of the scans will be rendered using 
the “Segment editor” module, and the view layout will be set to “four-up” mode to simultaneously 
display the 3D rendering along with the three orthogonal views (sagittal, coronal, and axial). The 
3D view facilitated confirmation of landmarks' positions in the spatial space (58). Cephalometric 
analysis pre-treatment (T0) and post-treatment (T1) (after the first series of aligners (15-20 
aligners)) lateral cephalograms will be imported into Dolphin Imaging™ software. Cephalometric 
landmark location measurements (linear and angular) Landmark points will be initially identified 
and approximated in the sagittal view by scrolling through the slices, then will be refined in the 
coronal and axial views. Final positional confirmation will be done on the 3D model when 
visualisation of the landmark is possible (59). This standardised viewing sequence will be 
implemented to enhance consistency across the cases, and superimpositions will be independently 
performed using Dolphin Imaging™ by two orthodontic faculty members. Following anterior 
cranial base, maxillary, and mandibular structural superimpositions, three reference planes (S-N, 
ANS-PNS, and Go-Me) were transferred from the T0 tracing to the T1 tracing. Eight cephalometric 

22 
 
measurements were generated by the computer operations in Dolphin Imaging™ (Figure 3.6). The 
average values of estimates derived by the two orthodontists were used.  
3.8.2.2 Measurement variable outcomes will be as follows: 
1. Dental and skeletal leaners and angular changes (Figure 3.7): 
The cephalometric analysis will include the following:(1) Overbite (the overlap of the 
anterior teeth in the vertical dimension); (2) U1 to palatal plane angle (the inclination of the 
maxillary central incisor relative to the palatal plane); (3) L1 to mandibular plane angle (IMPA) 
(the angle formed by the long axis of the lower incisor (L1) and the mandibular plane); (4) 
Interincisal angle. (The relative spatial position along the long axis of the most prominent 
(anteriorly positioned) maxillary and mandibular central incisors); (5) U6 to palatal plane distance 
(Represents the perpendicular distance from the mesiobuccally cusp of the maxillary first molar 
(U6) to the palatal plane (PP)); (6) U1 to palatal plane distance (the perpendicular distance from 
the tip of the maxillary central incisor (U1) to the palatal plane (PP)); (7) L6 to mandibular plane 
distance (the perpendicular distance from the mesial cusp tip of the lower first molar (L6) to the 
mandibular plane (MP), also known as the mandibular plane); (8) L1 to mandibular plane distance 
(a linear cephalometric measurement in orthodontics that quantifies the distance from the incisal 
edge of the mandibular central incisor (L1) to the mandibular plane). 
 
 
 
Figure 3.7: Cephalometric analysis: i. Overbite; mm; ii. U6 (Upper 1st molar) to palatal plane 
distance, mm; iii. U1 (Upper central incisor) to palatal plane distance, mm; iv. L6 (Lower 1st 
molar) to mandibular plane distance, mm; v. L1 (Lower central incisor) to mandibular plane 
distance, mm; vi. L1 (Lower central incisor) to mandibular plane angle (IMPA); vii. U1 (Upper 
central incisor) to palatal plane angle; viii. Interincisal angle. 
The amount of molar intrusion will be measured following these steps (Figure 3.8) 
Withayanukonkij et al. (60): 
 (1) Palatal plane (PP) will set,  
(2) The deepest point of the central pit (C-pit) will be in the coronal and sagittal view, and  

23 
 
(3) The vertical distance from C-pit to PP (U6-PP) will be measured.  
The difference between T0 and T1 will be the intrusion amount, and the right and left sides will 
be averaged. 
 
Figure 3.8: Show maxillary molar measurement. C-pit indicates central pit of maxillary molar; 
PP. palatal plane; U6-PP, vertical distance from C-pit to PP. 
2. Patient-reported outcomes measures (PROMs) (appendix 1) 
Participants will complete a set of Patient-Reported Outcome Measures (PROMs). 
Initially, participants will be required to provide several pieces of information, including name, 
date of birth, gender, residential address, phone number, email address, and date of consultation. 
Subsequently, participants from all three study groups will respond to ten PROM items assessing 
various aspects of outcome measures: “I feel pain”, “I can move more easily”, “I feel strong”, “I 
feel coordinated”, “I feel tired”, “I can sleep”, “I can do activities of daily living”, “I can return to 
work and sports”, “I am satisfied with my care”, and “I would recommend physical therapy to 
others”. Each item will be rated using a 5-point Likert scale, with response options ranging from 
1 (strongly disagree) to 5 (strongly agree) (Figure 8). All personal and response data will be treated 
with strict confidentiality. This interview questioner will take before and after the treatment. 
 
4.0 Statistical analysis 
 
Numerical data obtained from finite element analysis tests and clinical trials will be 
gathered using Microsoft Excel and subsequently analysed using SPSS Statistics for Windows 
version 26.0 (IBM Corp., Armonk, NY, USA). Prior to inferential analyses, the distribution of the 
data will be assessed for normality using the Shapiro-Wilk and Kolmogorov-Smirnov tests. A one-
way analysis of variance (ANOVA) will be employed to evaluate statistically significant 
differences among the three groups—conventional clear aligners with attachments, 3D direct 
printed shape-memory aligners with attachments and 3D direct printed shape-memory aligners 
without attachments—across a range of dependent variables, including: (i). Overbite (mm); (ii). 
U6 (upper 1st molar) to palatal plane distance (mm); (iii). U1 (upper central incisor) to palatal 
plane distance (mm); (iv). L6 (lower 1st molar) to mandibular plane distance (mm); (v). L1 (lower 
central incisor) to mandibular plane distance (mm); (vi). L1 (lower central incisor) to mandibular 
plane angle (IMPA); (vii). U1 (upper central incisor) to palatal plane angle; (viii). Interincisal 
angle. A paired T-test will be conducted to compare the results of the patient-reported outcome 

24 
 
measures (PROMs), and where significant group effects are identified, post hoc comparisons using 
Tukey’s Honestly Significant Difference (HSD), or Bonferroni correction will be conducted to 
determine specific intergroup differences. The significance level was set at p < 0.05. 
4.1 Intra-examiner and inter-examiner reliability: 
One researcher performed all the measurements at the start. Two weeks later, the same and 
another calibrated independent examiner repeated the whole measurements on 10 randomly 
selected measurements for analysis of intra- and inter-examiner reliability using the Intraclass 
Correlation Coefficient (ICC). The calculated ICC ranged from 0.82 to 0.96, indicating good to 
excellent agreement between examiners and across time. 
 
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30 
 
6.0 Appendices 
 
Appendix 1: Patient-reported outcomes measures (PROMs). 
 

 
STUDY WORKFLOW 
 
 
Evaluating the effectiveness of 3D directly printed 
shape memory aligners in the management of anterior 
open bite in adult patients. 
 
 
 
 
 
Date: 28/Jan/2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study flowchart: 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluating the efficiency of 3D directly printed shape memory aligners in the treatment of anterior 
open bite in adult patients. 
Ethical approval 
Sample size calculation 
Study design and grouping 
Digital impression and appliances 
Conventional clear aligner   
3D direct-printed shape memory aligner   
Finite element analysis 
Clinical trial 
Enrolment of patient based on inclusion criteria (n= ) 
Excluded based on exclusion criteria 
(n= )  
Not meeting inclusion criteria (n= ) 
Declined to participate (n= ) 
Other reasons (n= ) 
Randomised (n= ) 
Enrolment 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical analysis 
Report writing 
End 
Allocated to intervention (n= ) 
Received allocated intervention (n= ) 
Did not receive allocated intervention 
(give reasons) (n= ) 
Analysed for primary outcome (n= ) 
Excluded from analysis (give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 
Lost to follow-up for primary outcome (give 
reasons) (n= ): 
Analysis 
Allocation 
Follow-Up 
Allocated to intervention (n= ) 
Received allocated intervention (n= ) 
Did not receive allocated intervention 
(give reasons) (n= ) 
Allocated to intervention (n= ) 
Received allocated intervention (n= ) 
Did not receive allocated intervention 
(give reasons) (n= ) 
Discontinued intervention (give reasons) 
(n= ) 
Lost to follow-up for primary outcome (give 
reasons) (n= ): 
Discontinued intervention (give reasons) 
(n= ) 
Lost to follow-up for primary outcome (give 
reasons) (n= ): 
Analysed for primary outcome (n= ) 
Excluded from analysis (give reasons) (n= ) 
Analysed for primary outcome (n= ) 
Excluded from analysis (give reasons) (n= ) 

سجل المناقشة والموافقة المستنيرة  
ل
أشعة التصوير المقطعي المحوسب باستخدام شعاع المخروط (CBCT) 
Evaluating the effectiveness of 3D directly printed 
shape memory aligners in the management of anterior 
open bite in adult patients. 
INFORMED CONSENT/ Date: 28/Jan/2026 
1 
 
 
اسم المريض:
 
 
تاريخ الميالد: / /
 
 
:اإلجراء تصوير مقطعي محوسب باستخدام شعاع مخروطي (CBCT)
 ، والذي يُسمى أحيانًا باألشعة السينية ثالثية األبعاد، هو
تقنية أشعة سينية تشبه التصوير المقطعي المحوسب الطبي. تنتج فحوصات التصوير المقطعي المخروطي (CBCT) 
 صورًا
لجسمك تُظهر الهياكل الداخلية في مقطع عرضي بدالً من الصور المتداخلة التي تنتج عادةً عن األشعة السينية السنية التقليدية.
 
 ،يتطلب التشخيص وتخطيط العالج فهمًا أكثر اكتماالً لتشريح وجهك، بما في ذلك على سبيل المثال ال الحصر: األسنان، الفك
والهياكل/العظام الوجهية. تعد أشعة CBCT 
 ،مفيدة بشكل خاص لتشخيص المرضى الذين لديهم أسنان مدمرة، أو زراعة أسنان
أو خضعوا لعالجات جراحية و/أو قد يعانون من مشاكل في مجرى الهواء. باختصار، قد تكون أشعة CBCT 
 مفيدة في تقييم
 وتشخيص الحاالت التي ال يمكن رؤيتها بشكل صحيح باستخدام األشعة السي
نية التقليدية لألسنان.
 
 
:النساء 
 ال يُوصى بإجراء فحوصات CBCT 
 للنساء الحوامل بسبب الخطر المحتمل على الجنين. (التوقيع أدناه حسب
 ).االقتضاء 
 ًلست حامال          
 
 أنا حامل                 
 ًلست متأكدة مما إذا كنت حامال.
 
 
:المخاطر تعرضك أشعة CBCT
 ، مثل األشعة السينية التقليدية، لإلشعاع. هناك بعض المخاطر الكامنة والمحتملة من األشعة
 ،السينية. الجرعة تقريبًا هي نفسها ما يلي من مكافئات جرعة اإلشعاع الخلفية في الواليات المتحدة: يوم واحد لألسنان العلوية3 
أيام لألسنان األمامية السفلية و5 أيام لألسنان الخ لفية السفلية. بدي
ل لفحص CBCT 
 هو األشعة السينية التقليدية لألسنان، ومع
ذلك، فإن لها القيود التي تم اإلشارة إليها سابقًا.
 
 
 بينما قد تُرى أجزاء من تشريحك خارج فمك وفكك في الفحص، فإن تدريب الدكتور فوربس ورخصته في طب األسنان ال تسمح
 له بالتقييم والتشخيص خارج تخصصه في تقويم
األسنان. مسح CBCT 
،الذي تم اليوم   
 /
    
 
 / ، يهدف فقط إلى تسهيل
تشخيص حالتك السنية والمساعدة في إكمال خطة عالجك السني.
 
 
:اإلقرار/الموافقة أقر بأن البديل لفحوصات CBCT 
 هو األشعة السينية التقليدية لألسنان، ومع ذلك، فإن لها قيودًا تم اإلشارة
إليها سابقًا. أقر أيضًا بأن طبيب التقويم غير مسؤول عن قراءة أو تفسير أو إجراء تشخيص بناءً على مسح CBCT 
 يتجاوز
 نطاق خبرته/مجال رعايته التقويمية.
 
 
 أنا، ، البالغ من العمر18
 
 عامًا أو أكثر، أقر بأنني قرأت نموذج الموافقة هذا وأنني أفهم اإلجراء الذي سيتم تنفيذه، وفوائده
 ومخاطره والبدائل المتاحة. أقر بأنني قد أتيحت لي الفرصة الكاملة لمناقشة هذا اإلجراء مع طبيب تقويم األسنان، أو من ينوب
 عنه، وأن جميع أسئلتي قد تم اإلجابة عليها بما يرضيني قبل توقيع هذا النموذج. وبالتالي، أقدم موافقتي المستنيرة ألخصائي
 تقويم األسنان وموظفيه المعينين
إلجراء فحص CBCT.
 
 
باإلضافة إلى ذلك، أسمح ألخصائي تقويم األسنان وموظفيه المعينين بمشاركة الصور السريرية المأخوذة من مسح CBCT 
 اليوم مع أشخاص آخرين بغرض الحصول على رؤى إضافية حول حالتي السريرية، وألغراض تعليمية و/أو لتطوير المجال
الطبي/األسنان.
 
 
/توقيع المريض الوصي: / / /
 

سجل المناقشة والموافقة المستنيرة  
ل
أشعة التصوير المقطعي المحوسب باستخدام شعاع المخروط (CBCT) 
Evaluating the effectiveness of 3D directly printed 
shape memory aligners in the management of anterior 
open bite in adult patients. 
INFORMED CONSENT/ Date: 28/Jan/2026 
2 
 
 
 
RECORD OF DISCUSSION & INFORMED CONSENT 
FOR CONE BEAM COMPUTERIZED TOMOGRAPHY (CBCT) SCAN 
 
PATIENT’S NAME:  
 
Last 
First 
 
DATE OF BIRTH:  
 / 
 / 
 
 
PROCEDURE: A Cone Beam Computer Tomography (CBCT) scan, sometimes called a 3-D radiograph or x-ray, is an x-
ray technique that is similar to medical CT scans. CBCT scans produce images of your body that depict internal structures in 
cross-section rather than the overlapping images typically produced by conventional dental x-rays. 
Diagnosis and treatment planning requires a more complete understanding of your facial anatomy, including but not limited 
to: teeth, jaw, and facial structures/bones. CBCT scans are especially beneficial to the diagnoses of patients who have impacted 
teeth, dental implants, had surgical treatments and/or may suffer from airway issues. In short, CBCT scans may be useful in 
evaluating and potentially diagnosing conditions which cannot be properly seen with conventional dental x-rays. 
 
WOMEN: CBCT scans are NOT recommended for pregnant women because of possible danger to the fetus. (Initial below 
as appropriate.) 
   I am not pregnant 
 
 I am pregnant       I am unsure whether I am pregnant 
 
RISKS: CBCT scans, like conventional x-rays, expose you to radiation. There are certain inherent and potential risks from x-
rays. The dose is approximately the same as the following U.S. background radiation dose equivalents: 1 day for upper teeth, 
3 days for lower front teeth and 5 days for lower back teeth. An alternative to a CBCT scan are conventional dental x-rays, 
however, they have the limitations previously noted. 
 
While parts of your anatomy beyond your mouth and jaw may be seen on the scan, Dr. Forbes’ training and dental license 
does not provide for evaluating and diagnosing outside of his specialization of orthodontia. The CBCT scan taken today,    /    
/  
, is intended solely to facilitate diagnosis of your dental condition and aid 
in completion of your dental treatment plan. 
 
ACKNOWLEDGE/CONSENT: I acknowledge that an alternative to CBCT scans are conventional dental x-rays, however, 
they have limitations previously noted. I also acknowledge that Orthodontist is not liable for reading, interpreting and/or 
making a diagnosis based upon the CBCT scan beyond the orthodontic expertise/scope of care. 
 
I,  
, being 18 years or older, certify that I have read this consent form and that I understand the 
procedure to be performed, and its benefits, risks and alternatives. I acknowledge that I have had a full opportunity to discuss 
this procedure with the orthodontist, or his designee, and have had any/all questions answered to my satisfaction prior to 
signing this form. Thus, I give my informed consent to the orthodontist and his designated staff to perform the CBCT scan. 
 
In addition, I give permission to the orthodontist and his designated staff to share clinical images taken from today’s CBCT 
scan with other persons for the purpose of gaining additional insight on my clinical condition, for educational purposes and/or 
the development of the medical/dental field. 
 
PATIENT/GUARDIAN SIGNATURE:  
/ 
 / 
 /