Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires: A Randomized Clinical Trial
Phase: NA
Conditions: Aligning Archwires
Sponsor: University of Baghdad

 
 
 
 
 
 
  
 
 
Effectiveness of tubular coaxial nickel-titanium 
and copper nickel-titanium orthodontic 
aligning archwires: A randomized clinical trial 
 
 
A Protocol Submitted to 
the Council of the College of Dentistry, University of Baghdad 
in Partial Fulfillment of Requirements for the Degree of Master 
Science in Orthodontics  
 
By 
Reyam Mohammed Noori 
B.D.S. 
 
Supervised by: 
Assistant Professor 
Dr. Yassir Abdulkadhim Yassir  
B.D.S, M.Sc., Ph.D. (Orthodontics) (UK)  
 
 
 
Baghdad-Iraq 
November, 2021 
Republic of Iraq 
Ministry of Higher Education 
and scientific Research 
University of Baghdad 
College of Dentistry 

 
 
 
 
 
 
Certification of the Supervisor 
This is to certify that the preparation and organization of this protocol entitled 
"Effectiveness of tubular coaxial nickel-titanium and copper nickel-titanium 
orthodontic aligning archwires: A randomized clinical trial" had been made by 
the master student Reyam Mohammed Noori under my supervision, at the 
Department of Orthodontics/College of Dentistry/University of Baghdad in partial 
fulfillment of the requirement of the Master degree in Orthodontics. 
 
 
 
 
Assistant Professor  
Dr. Yassir Abdulkadhim Yassir 
B.D.S, M.Sc., Ph.D. (Orthodontics) (UK) 
Department of Orthodontics 
College of Dentistry/University of Baghdad 
2021 
(The Supervisor)

Study Protocol 
 
 
 
 
 
1 
 
Effectiveness of tubular coaxial nickel-titanium and copper 
nickel-titanium orthodontic aligning archwires:  
A randomized clinical trial 
 
Introduction 
The orthodontic market receives new products every day; consequently, a wide 
variety of options are available for orthodontists. New introductions in orthodontics 
have an ultimate goal of improving patient care including diagnosis, treatment 
planning, treatment mechanics, and treatment outcomes by making procedures more 
effective and efficient. Choosing bracket-archwire combination has a determining 
effect on the subsequent orthodontic outcomes (Fleming et al., 2010; Montasser et 
al., 2016). In fixed orthodontics, wires are used for applying forces to the teeth, so 
selection of the appropriate wire is essential for success at various stages of treatment 
(Jian et al., 2013; Mahmoudzadeh et al., 2018). 
Controlled and predictable tooth movement with minimal damage to the teeth and 
their supporting structures can be obtained by using light continuous force which is 
ideal for orthodontic treatment. To be clinically efficient, this force should cause 
maximum tooth movement with minimum root resorption and pain (Wang et al., 
2018; Azizi et al., 2021). A combination of excellent springiness, excellent strength, 
and a large range of action that produces a flat load deflection rate has made NiTi 
wires ideal archwires to be chosen at the initial stages of orthodontic treatment 
(Kapila and Sachdeva, 1989; Sebastian et al., 2019). In order to provide clinical 
advantages, different elements have been added since the introduction of NiTi 
archwires into orthodontics. Copper is one of these elements that have been added to 
nickel-titanium, to lower the loading stress while providing relatively high unloading 

Study Protocol 
 
 
 
 
 
2 
 
stress, which can result in more effective orthodontic tooth movement (Gil and 
Planell, 1999; Atik et al., 2019). 
Multistranding of archwires has been successfully attempted with stainless steel 
wire to gain mechanical advantages such as increased flexibility and a reduced load 
deflection rate (Rucker and Kusy, 2002; Sebastian, 2012). The same principle was 
applied in case of superelastic NiTi, this resuls in introduction of Supercable, a seven-
stranded round coaxial superelastic NiTi archwire which became commercially 
available in 1995. Laboratory tests seem to suggest that these wires exert only 36% 
to 70% of the force of solid NiTi wires (Berger and Waram, 2007; Sebastian, 
2012). Full bracket engagement with extremely low unloading force delivery is 
possible with this Supercable wire because of its high superelastic properties (Berger 
and Jeffrey, 2008; Modi et al., 2020). 
Recently, Speed six-stranded coaxial tubular superelastic NiTi is introduced into 
the market. It has many advantages over single-stranded superelastic NiTi, such as 
shortening of treatment time, increased spring back, resistance to deformation, and it 
delivers low-force (Joseph et al., 2019). It has an increased flexibility by a “hollow 
center” design to allow it to fold over on itself so it can be fully engaged in the severe 
malalignment, while applying only a portion of the force levels of conventional initial 
archwires (Sebastian et al., 2019). 
Manufacturers of archwires claim that some archwire is ideal for use in clinical 
orthodontics based on specific properties, determined by laboratory testing, the 
performance of these materials in vivo is much more important for orthodontists and 
their patients. Early clinical trials using new arch wire materials failed to demonstrate 
improved alignment and there are a number of factors that may be suggested to 
influence the performance of any given archwire clinically such as: type of wire and 
properties produced during manufacturing, size and type of brackets used, 

Study Protocol 
 
 
 
 
 
3 
 
interbracket distance, degree of initial malalignment of teeth and treatment duration 
may all effect the success of orthodontic treatment (Wang et al., 2018). 
Sebastian et al. (2019) reported in their study that there is no statistically 
significant difference between the alignment efficiency of coaxial tubular 
superelastic NiTi and single-stranded superelastic NiTi for relieving lower anterior 
crowding in extraction cases. In contrast, Joseph et al. (2019) concluded that coaxial 
tubular superelastic NiTi wires showed a significant effectiveness than single-
stranded NiTi in reducing lower anterior crowding after 4, 8, and 12 weeks. This was 
supported by a systematic review and meta-analysis of experimental clinical 
evidence on initial aligning archwires and archwire sequences which revealed that a 
multistranded Aact NiTi archwires were significantly more efficient in terms of three 
dimensional (3D) contact point movement than its single-stranded analogs 
(Papageorgiou et al., 2014). 
Other studies concluded that both A-NiTi and Cu-NiTi archwires are equally 
effective for tooth alignment (Atik et al., 2019; Azizi et al., 2021). 
The Cochrane review by Wang et al. (2018) revealed that there is a need for 
further randomized clinical trials (RCTs) to determine the best aligning archwire. 
Therefore, since there is no clinical study has been conducted until now to assess the 
alignment efficiency of superelastic coaxial tubular NiTi wire compared to Cu-NiTi 
wire, and since there is insufﬁcient evidence to determine whether any of these 
archwire materials is superior to the other in terms of alignment rate, time to 
alignment, pain and root resorption. Hence, this RCT will be performed to compare 
between superelastic coaxial tubular NiTi wire and Cu-NiTi wire to assess these 
aspects in crowding cases. 
 
 
Aim and Objectives 

Study Protocol 
 
 
 
 
 
4 
 
Aim 
 The aim of this study is to compare the effectiveness of using coaxial tubular 
superelastic nickel-titanium and copper-nickel-titanium archwires during the initial 
phase of orthodontic treatment. 
 
Objectives 
Primary Objective 
 To compare the difference in the amount of crowding relief of the mandibular 
incisors after 4, 8, 12 and 16 weeks from the start of treatment. 
 
Secondary Objectives 
1. To compare the amount of orthodontically-induced inflammatory root resorption 
(OIIRR) in the apical region of mandibular central incisors, after 16 weeks, 
between the two groups of archwires. 
2. To compare the amount of pain perception between the two groups of archwires 
during the 1st week after each wire placement. 
 
The null hypothesis is that “there is no significant differences in the effectiveness of 
using coaxial tubular superelastic nickel-titanium and copper nickel-titanium 
archwires during the initial phase of orthodontic treatment”. 
 
 
 
 
 
 
Methodology 

Study Protocol 
 
 
 
 
 
5 
 
Study design 
This will be a multicenter randomized clinical trial. 
 
Settings 
Different private clinics and general hospitals will allocate patients for this trial. 
 
Subjects 
Participants for this study will include any patient seeking fixed appliance 
orthodontic treatment according to the below criteria: 
 
Inclusion Criteria: 
1. Patients indicated for fixed appliance orthodontic treatment with 5-9 mm 
crowding of mandibular anterior teeth according to Little's irregularity index 
(LII). 
2. Presence of all the mandibular permanent teeth, except the third molars. 
3. Overbite and overjet that do not interfere with bracket placement on mandibular 
anterior teeth. 
4. No history of trauma or root resorption in the mandibular incisors. 
 
Exclusion Criteria: 
1. Previous orthodontic treatment. 
2. Less than 5 mm of mandibular incisors crowding (LII). 
3. Severe crowding which requires treatment by extraction of premolars in the 
mandibular arch. 
4. Blocked-out teeth that cannot be engaged with the aligning archwire. 
5. Prior experience of periodontal disease and loss of attachment. 
 
Sample Size 

Study Protocol 
 
 
 
 
 
6 
 
The sample size was calculated to detect a difference of 1.5 mm in the amount of 
crowding relief between the two treatment groups according to the data obtained 
from the study by Nabbat and Yassir (2020). This revealed that 13 patients in each 
trial arm will be sufficient to detect this clinical difference (Totals 26 patients). In 
order to account for dropouts, a total of 30 patients will be calculated.   
 
Intervention 
Patient Identification and Informed Consent 
The patients will be initially assessed for eligibility to be included in the study by 
the investigator (RM). Those who will meet the inclusion criteria will be informed 
about the nature of the study verbally to take the initial approval for participation. 
Then they will be provided by the patient information sheet and consent form. 
 
Randomization 
 A simple randomization will be used for this study.  
 
Blinding 
As the study will be conducted in different clinics, all data collection and 
measurement will be completed with the investigator being masked to the allocation 
groups, though blinding of the operator will not be possible during the archwire 
placement.  
 
Intervention Protocol 
The patients will be treated with straight wire appliance using MBT prescription 
brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth 
polishing will be performed with pumice and rubber cup, followed by water rinsing 
and air drying  

Study Protocol 
 
 
 
 
 
7 
 
Archwire sequence for each group will be as follows: 
1. Coaxial tubular superelastic nickel-titanium Group (TuNT) (Speed tubular 
supercable, Speed System™ Orthodontics, Ontario, Canada): 
 0.016-inch  
 0.018-inch  
2. Copper-nickel-titanium Group (CuNT) (Damon Optimal-Force Copper Ni-Ti®, 
Ormco, Glendora, Calif): 
 0.014-inch 
 0.018-inch 
All the participants will receive a standardized treatment protocol. At the day of 
bonding, 0.016-inch archwire will be placed for the TuNT group. Eight weeks later 
it will be replaced by the 0.018-inch archwire for another eight weeks. While, for the 
CuNT group, 0.014-inch archwire will be placed at the day of bonding and eight 
weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. 
Archwires will be tied to the bracket by elastomeric modules. If there is any 
debonding during treatment, this should be dealt with as an emergency case and re-
bonded within 24 hours, otherwise the case will be considered as dropout. Since this 
study will be performed during the initial phase of treatment, no deviation in the 
protocol of treatment will be accepted (such as adding additional archwire in the 
sequence or using power chain). A good-quality alginate impression for the lower 
arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study 
model is obtained. Periapical X-ray for the mandibular central incisors will be taken 
pre-treatment and after 16 weeks. The participants will be provided by a visual analog 
scale (0-10) to record their pain perception during the first week after each wire 
placement. 
Data Collection and Measurements 

Study Protocol 
 
 
 
 
 
8 
 
The following data will be collected and measured during the course of this trial 
for both groups: 
Type of measurement 
Pre-treatment 
T0 
After 4 weeks 
T1 
After 8 weeks 
T2 
After 12 weeks 
T3 
After 16 weeks 
T4 
Little’s irregularity 
index 
√ 
√ 
√ 
√ 
√ 
Root resorption using 
the scoring index that 
was provided by 
Malmgren et al. (1982) 
√ 
 
 
 
√ 
 
Pain perception using 
visual analog scale (0-10) 
24 
hours 
2nd 
day 
3rd 
day 
4th 
day 
5th 
day 
6th 
day 
7th 
day 
 
Study model which should be free from any discrepancy (such as bubbles) will be 
used to measure LII using a digital Vernier caliper to calculate the amount of mesial 
and distal contact displacement from the mesial contact surface of right mandibular 
canine to that on the other side, to the nearest 0.01 mm. The sum of these 
measurements represents the amount of LII (Little, 1975). 
Root resorption will be assessed using the scoring index by Malmgren et al. 
(1982): 
 Grade 0: Absence of apical root resorption. 
 Grade 1: Irregular apical root contour. 
 Grade 2: Minor apical root resorption, a small area of root loss amounting to 
less than 2 mm. 
 Grade 3: Severe apical root resorption from 2 mm to one third of the original 
root length. 
 Grade 4: Extreme apical root resorption exceeding one third of the original 
root length. 
 

Study Protocol 
 
 
 
 
 
9 
 
The participants will be asked to record their pain perception for the first seven 
days after placement of archwire using visual analog scale as shown below: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

Study Protocol 
 
 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1: Flowchart of data collection and measurement during this RCT. 
During the 1st Week  
(From the 5th visit) 
Recording of pain perception using VAS  
Changing elastic modules 
Impression for lower arch / Measure LII 
6th Visit 
(4 weeks from the 5th visit) 
7th Visit 
(2 months from the 5th visit) 
Impression for lower arch / Measure LII 
Taking periapical radiograph / Assess OIIRR 
End of the trial 
Continue treatment for the patients 
1st Visit 
Checking eligibility 
Check the inclusion criteria of the study 
Provide the patient/parent patient information sheet and consent 
form 
2nd Visit 
Consent, allocation, and 
records 
Consent for treatment (and answer any inquiries) 
Randomization and allocation to: TuNT or CuNT 
Impression for lower arch / Measure LII 
Taking periapical radiograph / Assess OIIRR 
3rd Visit 
Bonding 
Placement of the 1st archwire 
Changing elastic modules 
Impression for lower arch / Measure LII 
4th Visit 
(4 weeks from the 3rd visit) 
During the 1st Week  
(From the 3rd visit) 
Recording of pain perception using VAS  
5th Visit 
(2 months from the 3rd Visit) 
Placement of the 2nd archwire 
Impression for lower arch / Measure LII 

Study Protocol 
 
 
 
 
 
11 
 
Timetable 
Duty 
Expected time 
Patient identification and allocation 
4 months 
Intervention period 
4 months 
Data collection and analysis 
1 month 
Writing up the thesis 
10 months (starting from the beginning of the trial) 
Total expected time to finish 
About 10 to 11 months 
 
 
Stopping Roles 
If there is a severe pain in one group that cannot be tolerated by the participants, 
the study should be terminated. 
 
Budget and Funding  
The study is self-funded. 
 
Ethical Approval 
The protocol will be submitted to ethics committee. 
 
Data Management and Analysis 
Data will be analyzed using the Statistical Package for Social Sciences for 
Windows, version 25.0 (SPSS Inc., Chicago, Illinois, USA). The following statistical 
analyses will be used: 
 
Descriptive Statistics 
These will include number, frequencies, percentages, mean, median, and standard 
deviation. 
 

Study Protocol 
 
 
 
 
 
12 
 
Reliability Statistics 
Little’s irregularity index: An intraclass correlation coefficient (ICC) will be used to 
test inter- and intra-examiner reliability of 10 study models measured twice with a 
four-week interval. 
Root resorption: Weighted kappa test will be used to test inter-examiner and intra-
examiner reliability of 10 periapical radiographs scored twice with a four-week 
interval. 
 
Inferential Statistics 
Homogeneity of variance between groups will be checked by Levene’s test, while 
normality of data distribution will be checked by Shapiro Wilk test. Assuming that 
the data are normally distributed due to large sample size (≥ 30) according to the 
central limit theorem, the following tests will be used: 
 Independent samples t-test: to test the difference in the amount of crowding 
between groups. 
 Wilcoxon signed-rank test and Mann-Whitney U test: to compare the root 
resorption at T0 and T4 and within each group and between groups (categorical 
data). 
 Chi-square test: to compare pain perception between groups.   
The significance level will be set as p < 0.05  
 
Further Considerations 
Pilot Study 
A pilot study will NOT be conducted. 
 
Dissemination 
Postgraduate M.Sc. Thesis. 

Study Protocol 
 
 
 
 
 
13 
 
References 
 Atik, E., Gorucu-Coskuner, H., Akarsu-Guven, B. and Taner, T. (2019) A 
comparative assessment of clinical efficiency between premium heat-activated 
copper nickel-titanium and superelastic nickel-titanium archwires during initial 
orthodontic alignment in adolescents: a randomized clinical trial. Progress in 
Orthodontics, 20 (1), 1-10. 
 Azizi, F., Extiari, A. and Imani, M.M. (2021) Tooth alignment and pain 
experience with A-NiTi versus Cu-NiTi: a randomized clinical trial. BioMed 
Central Oral Health, 21 (1), 1-8. 
 Berger, J.E.F.F. and Waram, T. (2007) Force levels of nickel titanium initial 
archwires. Journal of Clinical Orthodontics, 41 (5), 286-292. 
 Berger, J.L. (2008) The SPEED system: an overview of the appliance and clinical 
performance. Seminars in Orthodontics, 14 (1), 54-63.  
 Fleming, P.S. and Johal, A. (2010) Self-ligating brackets in orthodontics: a 
systematic review. The Angle Orthodontist, 80 (3), 575-584. 
 Gil, F.J. and Planell, J.A. (1999) Effect of copper addition on the superelastic 
behavior of Ni‐Ti shape memory alloys for orthodontic applications. Journal of 
Biomedical Materials Research, 48 (5), 682-688. 
 Jian, F., Lai, W., Furness, S., McIntyre, G.T., Millett, D.T., Hickman, J. and 
Wang, Y. (2013) Initial arch wires for tooth alignment during orthodontic 
treatment with fixed appliances. Cochrane Database of Systematic Reviews, 2013 
(4): CD007859. 
 Joseph, J., Ninan, V.S., Abraham, M.E., John, J., Cherian, K.K. and Thomas, 
R.M. (2019) Arch expansion efficiency of coaxial tubular superelastic nickel-
titanium in comparison to single-stranded superelastic nickel-titanium while 
relieving mandibular anterior crowding: A randomized controlled study. Journal 
of International Society of Preventive and Community Dentistry, 9 (1), 60-64. 

Study Protocol 
 
 
 
 
 
14 
 
 Kapila, S. and Sachdeva, R. (1989) Mechanical properties and clinical 
applications of orthodontic wires. American Journal of Orthodontics and 
Dentofacial Orthopedics, 96 (2), 100-109. 
 Little, R.M. (1975) The irregularity index: a quantitative score of mandibular 
anterior alignment. American Journal of Orthodontics, 68 (5), 554-563. 
 Mahmoudzadeh, M., Farhadian, M., Alijani, S. and Azizi, F. (2018) Clinical 
comparison of two initial arch wires (A-NiTi and Heat Activated NiTi) for amount 
of tooth alignment and perception of pain: A randomized clinical 
trial. International orthodontics, 16 (1), 60-72. 
 Malmgren, O., Goldson, L., Hill, C., Orwin, A., Petrini, L. and Lundberg, M. 
(1982) Root resorption after orthodontic treatment of traumatized teeth. American 
Journal of Orthodontics, 82 (6), 487-491. 
 Modi, N., Gupta, R. and Borah, M. (2020) Newer orthodontic archwires-a review 
International Journal of Applied Dental Sciences, 6 (4), 90-94. 
 Montasser, M.A., Keilig, L. and Bourauel, C. (2016) Archwire diameter effect on 
tooth alignment with different bracket-archwire combinations. American Journal 
of Orthodontics and Dentofacial Orthopedics, 149 (1), 76-83. 
 Nabbat, S.A. and Yassir, Y.A. (2020) A clinical comparison of the effectiveness 
of two types of orthodontic aligning archwire materials: a multicentre randomized 
clinical trial. European Journal of Orthodontics, 42 (6), 626-634. 
 Papageorgiou, S.N., Konstantinidis, I., Papadopoulou, K., Jäger, A. and Bourauel, 
C. (2014) A systematic review and meta‐analysis of experimental clinical 
evidence on initial aligning archwires and archwire sequences. Orthodontics and 
Craniofacial Research, 17 (4), 197-215. 
 Rucker, B.K. and Kusy, R.P. (2002) Theoretical investigation of elastic flexural 
properties for multistranded orthodontic archwires. Journal of Biomedical 
Materials Research, 62 (3), 338-349. 

Study Protocol 
 
 
 
 
 
15 
 
 Sebastian, B. (2012) Alignment efficiency of superelastic coaxial nickel-titanium 
vs superelastic single-stranded nickel-titanium in relieving mandibular anterior 
crowding: a randomized controlled prospective study. The Angle Orthodontist, 82 
(4), 703-708. 
 Sebastian, B., Abraham, M.E., Sarma, P.S. and Cherian, K.K. (2019) Alignment 
efficiency of coaxial tubular superelastic nickel‐titanium vs single‐stranded 
superelastic nickel‐titanium in relieving mandibular anterior crowding in 
extraction 
cases: 
A 
single‐centre 
randomized 
controlled 
clinical 
trial. Orthodontics and Craniofacial Research, 22 (2), 105-111. 
 Wang, Y., Liu, C., Jian, F., McIntyre, G.T., Millett, D.T., Hickman, J. and Lai, 
W. (2018) Initial arch wires used in orthodontic treatment with fixed 
appliances. Cochrane Database of Systematic Reviews, 7 (7): CD007859. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Patient information sheet and consent form                                                                                      Ethics Committee 
 
 
 
 
2 
 
College of Dentistry – University of Baghdad 
Patient Information Sheet 
 
You are invited to participate in a scientific research. Please take your time to read the following 
information carefully before you decide whether or not you wish to participate. You can ask for 
clarifications or any more information about the study from the researcher and you can discuss 
this with outsiders. 
Information about the research  
1. Study title  
Effectiveness of tubular coaxial nickel-titanium and copper nickel-titanium orthodontic aligning 
archwires: A randomized clinical trial. 
2. What is the purpose of this study? 
To compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-
nickel-titanium archwires during the initial phase of orthodontic treatment. 
3. Where will the study be conducted?  
The study will be conducted in Different private clinics and general hospitals. 
4. What are the procedures to be followed and what will you be asked to do at each visit? 
No specific procedure but you should follow your doctor instruction regarding the care of fixed 
orthodontic appliance and inform your doctor if there is any breakage or a problem. 
5. How long will the participation in the study last? 
     Four Months 
6. If you decided to taking part in the study, will the treatment be different from the treatment 
you would get otherwise? 
There is no difference in the treatment plan that usually decided for your condition. 
7. Who should not enter the study? 
 
Previous orthodontic treatment. 
 
Less than 5 mm of mandibular incisors crowding (LII). 
 
Blocked-out teeth that cannot be engaged with the aligning archwire. 
 
Prior experience of periodontal disease and loss of attachment. 
8. What will be the benefits of the study? 
To the participant? Possibility of faster alignment of teeth with less pain and root resorption.  
     To the investigator? To determine which archwire is more effective in alignment of teeth. 
9. What are the possible risks of taking part? No risks 
10. If you feel severe discomfort or pain during the study, would you be able to take any relief 
medication? Yes, you can. but the pain perception should be recorded before taking the 
medication. 
11. Will your participation in the study interfere with your daily activities? No, it will not. 
12. Will you be informed of the results of the study? 
If you like, it will be submitted to you. 
 
If you agree to participate in this study, we will ensure your confidentiality with no one except the 
study researchers have the right to access your dental (medical) notes. 
Participation in this study is entirely voluntary and you are free to refuse to take part or to withdraw 
from the study at any time without having to give a reason and without this affecting your future 
medical care or your relationship with medical staff looking after you. 
Thank you for reading this Information Sheet and considering your participation in this 
study 

Patient information sheet and consent form                                                                                      Ethics Committee 
 
 
 
 
3 
 
Consent Form 
 
Please tick 
to confirm 
I confirm that I have read and understood the information sheet for the above study. 
I have had the opportunity to consider the information, ask questions and have had 
these answered satisfactorily. 
 
I understand that my participation is voluntary and that I am free to withdraw at any 
time without any medical/dental care affected. 
 
I understand that relevant sections of my medical notes and data collected during 
the study may be looked at by individuals from the College of Dentistry – University 
of Baghdad where it is relevant to my taking part in this research. I give permission 
to these individuals to have access to my records. 
 
I agree to take part in the above study. 
 
 
Regarding any information and records taken during the research please specify your 
acceptance to share them as you desire: 
 
Personal 
data 
X-rays 
Extra-oral 
photographs 
Intra-oral 
photographs 
Others 
Confidential 
 
 
 
 
 
For consultation 
 
 
 
 
 
For teaching 
 
 
 
 
 
For conferences 
 
 
 
 
 
For publication 
 
 
 
 
 
 
 
Name 
Signature 
Date 
Participant 
 
 
 
Parent/guardian 
(if appropriate) 
 
 
 
Person taking consent 
 
 
 
 
Person to contact: 
Name: Dr. Reyam Mohammed Noori 
Phone No.: 07500535965 
Email: dr.rmn2017.777@gmail.com 
1 copy for the participant; 1 copy for the researcher