A Clinical Comparison of the Effectiveness of Two Moisture Insensitive Primers on Orthodontic Attachment Bond: A Randomized Clinical Trial
Phase: NA
Conditions: Dental Bonding
Sponsor: University of Baghdad

 
 
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A Clinical Comparison of the Effectiveness of 
Two Moisture Insensitive Primers on 
Orthodontic Attachment Bond: 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 of 
Science in Orthodontics 
 
 
By: 
Ahmed Abdulelah Abduljawad 
B.D.S. 
 
 
Supervised by: 
Assist Prof. Dr. Haraa Sabah Abdulameer 
B.D.S., M.Sc., PhD. (Orthodontics) 
 
 
Baghdad-Iraq 
January 2022 
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 " A 
clinical comparison of the effectiveness of two moisture insensitive primers on 
orthodontic attachment bond: a randomized clinical trial" had been made by the master 
student Ahmed Abdulelah Abduljawad under my supervision, at the Department of 
Orthodontics/College of Dentistry/University of Baghdad in partial fulfillment for the 
Degree of Master of Science in Orthodontics. 
 
 
 
 
Assist Prof. Dr. Haraa Sabah Abdulameer  
B.D.S., M.Sc., PhD. (Orthodontics) 
Department of Orthodontics 
College of Dentistry/ University of Baghdad 
2022 
(The Supervisor)

Study Protocol 
 
 
 
 
 
 
1 
 
 
A clinical comparison of the effectiveness of two moisture 
insensitive primers on orthodontic attachment bond: a 
randomized clinical trial 
Introduction 
The use of orthodontic bands has many disadvantages; it is time-consuming for 
the orthodontist, uncomfortable for the patient, the interproximal gaps had to be 
closed at the end of treatment and decalcification under bands sometimes occurred 
during treatment. Therefore, the obvious solution to these problems was for the 
clinician to bond the attachments directly to tooth enamel, thus eliminating the need 
for bands (Gange, 2015). 
The introduction of acid etching technique by Buonocore in 1955 and orthodontic 
brackets bonding by Newman in 1965 improved the overall orthodontic treatment 
results (Buonocore, 1955; Newman, 1965; Kumar et al., 2018). 
Orthodontic bracket bonding to etched enamel by the use of resin-based materials 
is a highly technique-sensitive procedure. Moisture control is the most important 
parameter in this process. Successful bracket bonding highly depends on the 
provision of a dry field. Contamination may occur after etching the tooth surface or 
after primer application, compromising the bonding procedure (Littlewood et al., 
2001; Cacciafesta et al., 2004; Safar Ali et al., 2021). 
Clinical conditions during bonding procedure include a risk of contamination of 
the etched surface by saliva. Saliva contamination of the enamel surface is regarded 
as the most common reason for bond failure (Zachrisson, 1977; Paschos et al., 

Study Protocol 
 
 
 
 
 
 
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2008). Acid-etched enamel absorbs saliva, which reduces the surface energy and 
renders the surface less favorable for bonding (Evancusky and Meiers, 2000; 
Kumar et al., 2012). When the etched enamel is wet, most of the porosities become 
plugged, and the penetration of the resin is impaired, which results in resin tags of 
insufficient number and length (Hormati et al., 1980; Silverstone et al., 1985; 
Öztoprak et al., 2007). 
It must be noted, however, that the use of the terms ‘moist’ or ‘wet’ implies the 
presence of water, whilst saliva or crevicular fluid are considered ‘contaminants’. 
Although the presence of water can be prevented by adopting moisture control 
precautions during bonding procedures, the orthodontist is often faced with the 
problem of bonding in an environment with increased contamination risk from saliva 
(Cacciafesta et al., 1998; Wendl and Droschl, 2004). Because of their hydrophobic 
properties and absence of chemical adhesion, conventional bisphenol A-glycidyl 
methacrylate (Bis-GMA) adhesives require dry etched enamel for mechanical 
adhesion (Hormati et al., 1980; Grandhi et al., 2001). 
The failure rate of bonding to molars was greater than that of bonding to anterior 
teeth (Jung, 2014; Roelofs et al., 2016). A possible solution to this problem was 
offered by the development of the moisture insensitive primers (MIP). These novel 
bonding materials contain hydrophilic components such as Hydroxyethyl 
Methacrylate (HEMA), which act as a wetting agent, allowing a lower contact angle 
and rapid extension of the molecule which bonds easily to the resin composite. In 
addition, they contain alcohol, which acts as a drying agent that seeks out moisture, 
evaporates it from the bonding field, and brings the resin in; thus, ensuring an 
efficient bonding (Webster et al., 2001; Gange, 2015; Hadrous et al., 2019). 

Study Protocol 
 
 
 
 
 
 
3 
 
 
 These primers are commercially available nowadays as Transbond MIP (3M 
Unitek Dental Products, Monrovia, CA, USA) and Assure Plus universal bond 
(Reliance, Itasca, IL, USA). In the cloud, many in vitro studies supports the 
manufacturers’ claim that these two novel orthodontic systems provides sufficient 
shear bond strength of orthodontic attachments bonded under moisture contaminated 
conditions (Goswami et al., 2014; Kumar et al., 2018; Hadrous et al., 2019; 
Stefański et al., 2019). 
 Although these in vitro measurements provide useful information about the 
bonding efficiency of different types of materials, they should be interpreted with 
caution because of inherent limitations and because they cannot take into account a 
number of factors that play an important role in the mouth (Eliades and Brantley, 
2000). For your information, no previous clinical study was conducted to evaluate 
the efficacy of these primers on bond failure rate, therefore; this randomized clinical 
trial will be conducted to be more representative of the clinical reality. 
Aim and Objectives 
Aim 
To evaluate the clinical effectiveness of moisture insensitive primers in bonding 
molar tubes under moisture contaminated conditions. 
Objectives 
1- To evaluate and compare the clinical bond failure and survival rate of molar 
tubes using two moisture insensitive primers under moisture contaminated 
condition. 

Study Protocol 
 
 
 
 
 
 
4 
 
 
2- To compare the effectiveness of these primers between different arches, sides, 
gender and age differences. 
The null hypothesis is that “there is no significant differences in the bond failure 
rate of molar tubes using Transbond MIP and Assure Plus universal bond under 
moisture contamination during the function of archwires used during leveling and 
alignment stage of orthodontic treatment”. 
 
Methodology 
Study design 
A single-operator, a split-mouth, cross-quadrant, randomized controlled trial 
(RCT), with 1:1 allocation ratio.  
Settings  
Orthodontic patients seeking for orthodontic treatment with fixed orthodontic 
appliance will be recruited for this study. The study will be conducted in the 
Orthodontic Clinic at the College of Dentistry/University of Baghdad in addition to 
private dental clinics and Bab Al-Muadham specialized dental center in Baghdad, 
Iraq. Clinicians will be either specialist orthodontists or under training to become 
specialist orthodontists. 
Ethical approval will be obtained from the Ethics Committee of College of 
Dentistry/University of Baghdad prior to study commencement.  The patients were 
first evaluated by the principal investigator (A. A. A) to see if they were eligible for 
the research. Those who meet the inclusion criteria will be asked to assigned a 
comprehensive consent form prior to the start of trial. 
 

Study Protocol 
 
 
 
 
 
 
5 
 
 
Subjects/Materials 
Subjects 
Patients seeking for orthodontic treatment and their treatment will be planned with 
metal fixed orthodontic appliance (0.22" for both arches).  
Materials 
A- Orthodontic materials: 
1-Moisture insensitive primers: Transbond MIP (3M Unitek Dental Products, 
Monrovia, CA, USA) and Assure Plus universal bonding resin (Reliance, Itasca, 
IL, USA). 
2-Orthodontic adhesive: CONTEC lc (Dentaurum GmbH & Co. KG, Turnstr, 
Ispringen, Germany). 
3-Molar tubes: Stainless steel Classic Roth Tube with 0.022 slot (IOS International 
Orthodontics Services, Capricorn St, Stafford, TX, USA). 
4- 37% phosphoric acid: N-Etch (Ivoclar Vivadent, Schaan, Liechtenstein). 
5- Metal fixed orthodontic appliance with 0.022 slot and a universal sequence of 
orthodontic archwires used to finish leveling and alignment stage of orthodontic 
treatment. Orthodontic archwires used with brackets during orthodontic treatment. 
B- Other materials: 
oil- and fluoride-free coarse pumice powder, a rubber prophylactic cup, distilled 
water, bond brush, dental cotton pellets, articulating paper (ArtEXACT, Becht, 
Offenburg, Germany).  
 
 

Study Protocol 
 
 
 
 
 
 
6 
 
 
Instruments/equipment 
Instruments 
Cheek retractors, tube tweezers, bracket position gauge, dental mirror, probe and 
tweezers. 
Equipment 
 Light curing unit: (Light emitting diode, Eight teeth curing pen; Changzhou city, 
Jiangsu, P.R.China) Specification of light curing unit: Light intensity: 1500 
mW/cm2, Output wavelength: 380–515 nm. 
Sample Size  
To have adequate power (80%) to show a statistically significant difference (P < 
0·05) in proportions with at least one failed molar tube after 6 months, the RCT 
needed 33 patients in each group using a log rank test ignoring the matching. This 
assumes a difference of 35 percentage points (45% versus 80%, hazard ratio = 3·6). 
As an approximate allowance for the effect of matching, an estimated 33 patients in 
total were required using a stratified log rank test for analysis (Littlewood et al., 
2001; Wenger et al., 2008). 
Procedure/Intervention  
1-Sample Selection: 
Thirty-three consecutive patients will be eligible for the study if they fulfill the 
following inclusion criteria: 
1. Patients need metal fixed orthodontic appliance with 0.22"; 
2. Complete set of permanent dentition with fully erupted molar teeth on both 
arches; 

Study Protocol 
 
 
 
 
 
 
7 
 
 
3. Intact 1st molars and mainly their buccal surfaces are free from caries, fillings, 
or gingival hyperplasia; 
4. No occlusal interferences that can affect the ideal position of molar tubes, 
especially in the lower arch. 
2- Randomization: 
The primers will be randomly allocated using a split-mouth, cross-quadrant 
design. In each patient, two diagonal quadrants (i.e. upper right and lower left, or 
vice versa) will be randomly assigned to each primer group. The split-mouth design 
has several advantages over a complete randomization design: it compares treatments 
within patients so that variation between patients is eliminated (e.g. effect of the 
chewing habits of the patient). Furthermore, in terms of patient recruitment, which is 
always difficult to accomplish in clinical trials, at most half of the patients are needed 
in a split-mouth design compared with the corresponding whole-mouth design 
(Lesaffre et al., 2009). A potential disadvantage of the split-mouth design is that the 
treatment applied to one side can have a carry-across effect on the contralateral side 
of the mouth. This problem is limited with randomization (Thiyagarajah et al., 
2006).  
In order to ensure an equal distribution of primers between the right and the left side 
of the dental arches, the mouth of each patient will be divided into quadrants and the 
contralateral bonding pattern will be randomly alternated from patient to patient 
using a random plan generator (Randomization.com). A CONSORT diagram 
showing the flow of patients through each stage of the trial is shown in Figure 1. 
 
 

Study Protocol 
 
 
 
 
 
 
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3-Blinding: 
This study will be Double-blinded in which neither the patients nor the trial staff 
know which one of the primers a patient has received. This can be achieved by 
placing the two primers in two similar masked bottles and giving them numerical 
coding i.e. number one and number two coding for either type of primer (Schulz and 
Grimes, 2002).  
 
Figure 1 CONSORT flow diagram showing progress of subjects through the trial. 

Study Protocol 
 
 
 
 
 
 
9 
 
 
4-Procedure: 
 A single operator to avoid inter-operator variation will bond all molar tubes. A 
standardized protocol of tooth preparation and Molar tubes bonding will be adopted 
for all the patients. All teeth will be isolated and cleansed with a mixture of water 
and pumice using a rubber-polishing cup on a low speed hand piece. The teeth will 
be rinsed and dried with an oil-free air syringe, and will be etched with the 
conventional acid etching technique (37 percent orthophosphoric acid applied for 30 
seconds). They will be subsequently rinsed thoroughly with water for 10 seconds to 
ensure total removal of etchant according to the manufacturer’s instructions. 
 Without drying, one coat of the patient own non-stimulated saliva will be applied 
to the etched and wet surface using bond brush (Zeppieri et al., 2003; Endo et al., 
2008; Goswami et al., 2014). the excess will be blotted with a moist cotton pellet 
maintaining the surface moist (Kumar et al., 2018). 
A liberal coat of the Moisture-Insensitive Primer will be applied to the etched area 
of the teeth destined for a specific primer (split-mouth) using a nylon bond brush. 
Air will be gently blown on each tooth for 2 seconds, aiming the air stream 
perpendicular to the enamel surface then light cured for 20 seconds. 
 After etching and priming, molar tubes will be bonded to the teeth with CONTEC 
lc adhesive according to the manufacturer’s instructions. The CONTEC lc adhesive 
will be applied to the molar tube base. The molar tube will be positioned correctly 
on the buccal surface of the tooth, and pressed firmly into place to express adhesive 
from the rim of the molar tube base. Excess adhesive will be removed with an 
explorer before curing. Then, the molar tube will be light-cured with a light curing 
unit (1500 mW/cm2, 380–515 nm.) for 20 seconds: 5 seconds each from the mesial, 

Study Protocol 
 
 
 
 
 
 
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distal, occlusal and gingival aspects of each tube). after curing is complete the molar 
tubes will be inspected for occlusal interferences using articulating paper. The 
sample will be excluded from the trial if any occlusal interference was observed. 
Initial wires will be fitted 10-15 minutes after bonding completion in the context of 
the straight wire technique.  
All patients will receive the same instructions and will be seen at 3-4-week 
intervals. They will be, however, requested to inform the operator immediately and 
attend as soon as possible once a bond failure was apparent. They will be instructed 
to brush with a manual toothbrush using a fluoride-containing toothpaste. 
5-Data collection: 
Each patient will be monitored for 6 months. If a bond failed, the following will 
be recorded: 
(1) Tooth number where failure occurred; 
(2) Type of primer used; 
(3) Date of bond failure. 
Only the first failure of tubes will be taken into consideration. The teeth with 
recycled or newer tubes replaced will not be considered.  
 
 
 
 

Study Protocol 
 
 
 
 
 
 
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Timetable  
Table 1 
 
Procedure 
Time (months) 
1 
Material preparation and availability 
Two months 
2 
Patient recruitment 
Four months 
3 
Follow up 
Six months 
4 
Results analysis and interpretation 
Two months 
5 
Thesis writing 
Four months 
 
Total 
Eighteen months 
 
The follow up period ends after six months from the start of recruitment of each 
patient. A clinical trial with similar situations concluded that half (49.8 per cent) of 
the total bond failures occurred during the first 2 months of treatment (Mavropoulos 
et al., 2003). The probability of bond failure is greater immediately after bonding 
and during the first 3 months of bracket life (Campoy et al., 2010). 
Stopping Rules:  
No stopping rules. 
Budget and Funding:  
 The study is self-funded. 
 

Study Protocol 
 
 
 
 
 
 
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Ethical Approval:  
 The protocol will be submitted to ethics committee. 
Data Management and Analysis 
The data will be analyzed using SPSS software version 28.0.1 (IBM, Chicago, 
Illinois, USA). To find if there is significant difference, the number of bonding 
failures will be compared using the chi-square test, the tube survival rate will be 
estimated using the Kaplan–Meier analysis. The Tube survival distributions with 
respect to primer material, tooth location (upper/lower, right/left side), patient’s 
gender and age will be then compared by means of a log-rank test. Further analysis 
to investigate the effects of covariates will be carried out using the frailty Cox 
regression model with response time to failure. 
Further Considerations 
Pilot study 
 A pilot study will NOT be conducted  
Dissemination  
 Postgraduate Thesis. 
 
 
 
 

Study Protocol 
 
 
 
 
 
 
13 
 
 
References 
 
Buonocore, M.G. (1955). A simple method of increasing the adhesion of 
acrylic filling materials to enamel surfaces. Journal of dental research, 34, 
849-853. 
 
Cacciafesta, V., Jost-Brinkmann, P.-G., Subenberger, U. and Miethke, R.-R. 
(1998). Effects of saliva and water contamination on the enamel shear bond 
strength of a light-cured glass ionomer cement. American Journal of 
Orthodontics and Dentofacial Orthopedics, 113, 402-407. 
 
Cacciafesta, V., Sfondrini, M.F., Melsen, B. and Scribante, A. (2004). A 12 
month clinical study of bond failures of recycled versus new stainless steel 
orthodontic brackets. European Journal of Orthodontics, 26, 449-454. 
 
Campoy, M.D., Plasencia, E., Vicente, A., Bravo, L.A. and Cibrián, R. (2010). 
Effect of saliva contamination on bracket failure with a self-etching primer: A 
prospective controlled clinical trial. American Journal of Orthodontics and 
Dentofacial Orthopedics, 137, 679-683. 
 
Eliades, T. and Brantley, W. (2000). The inappropriateness of conventional 
orthodontic bond strength assessment protocols. The European Journal of 
Orthodontics, 22, 13-23. 
 
Endo, T., Ozoe, R., Sanpei, S., Shinkai, K., Katoh, Y. and Shimooka, S. 
(2008). Effects of moisture conditions of dental enamel surface on bond 
strength of brackets bonded with moisture-insensitive primer adhesive system. 
Odontology, 96, 50-4. 

Study Protocol 
 
 
 
 
 
 
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 
Evancusky, J. and Meiers, J. (2000). Microleakage of Compoglass-F and 
Dyract-AP compomers in Class V preparations after salivary contamination. 
Pediatric dentistry, 22, 39-42. 
 
Gange, P. (2015). The evolution of bonding in orthodontics. American Journal 
of Orthodontics and Dentofacial Orthopedics, 147, S56-63. 
 
Goswami, A., Mitali, B. and Roy, B. (2014). Shear bond strength comparison 
of moisture-insensitive primer and self-etching primer. journal of orthodontic 
science, 3, 89. 
 
Grandhi, R.K., Combe, E.C. and Speidel, T.M. (2001). Shear bond strength of 
stainless steel orthodontic brackets with a moisture-insensitive primer. 
American Journal of Orthodontics and Dentofacial Orthopedics, 119, 251-
255. 
 
Hadrous, R., Bouserhal, J. and Osman, E. (2019). Evaluation of shear bond 
strength of orthodontic molar tubes bonded using hydrophilic primers: An in 
vitro study. International Orthodontics, 17, 461-468. 
 
Hormati, A.A., Fuller, J.L. and Denehy, G.E. (1980). Effects of contamination 
and mechanical disturbance on the quality of acid-etched enamel. The Journal 
of the American Dental Association, 100, 34-38. 
 
Jung, M.-H. (2014). Survival analysis of brackets and tubes: A twelve-month 
assessment. The Angle Orthodontist, 84, 1034-1040. 
 
Kumar, I., Bhagyalakshmi, A., Shivalinga, B. and Raghunath, N. (2018). 
Evaluation of the effect of moisture and saliva on the shear bond strength of 
brackets bonded with conventional bonding system and moisture insensitive 

Study Protocol 
 
 
 
 
 
 
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primer: An in vitro study. International Journal of Orthodontic Rehabilitation, 
9, 145-154. 
 
Kumar, P., Shenoy, A. and Joshi, S. (2012). The effect of various surface 
contaminants on the microleakage of two different generation bonding agents: 
A stereomicroscopic study. Journal of Conservative Dentistry, 15, 265. 
 
Lesaffre, E., Philstrom, B., Needleman, I. and Worthington, H. (2009). The 
design and analysis of split-mouth studies: What statisticians and clinicians 
should know. Statistics in Medicine, 28, 3470-3482. 
 
Littlewood, S.J., Mitchell, L. and Greenwood, D.C. (2001). A Randomized 
Controlled Trial to Investigate Brackets Bonded with a Hydrophilic Primer. 
Journal of Orthodontics, 28, 301-305. 
 
Mavropoulos, A., Karamouzos, A., Kolokithas, G. and Athanasiou, A.E. 
(2003). In Vivo Evaluation of Two New Moisture-Resistant Orthodontic 
Adhesive Systems: A Comparative Clinical Trial. Journal of Orthodontics, 30, 
139-147. 
 
Newman, G.V. (1965). Epoxy adhesives for orthodontic attachments: progress 
report. American journal of orthodontics, 51, 901-912. 
 
Öztoprak, M.O., Isik, F., Sayınsu, K., Arun, T. and Aydemir, B. (2007). Effect 
of blood and saliva contamination on shear bond strength of brackets bonded 
with 4 adhesives. American Journal of Orthodontics and Dentofacial 
Orthopedics, 131, 238-242. 
 
Paschos, E., Westphal, J.-O., Ilie, N., Huth, K.C., Hickel, R. and Rudzki-
Janson, I. (2008). Artificial Saliva Contamination Effects on Bond Strength of 
Self-etching Primers. The Angle Orthodontist, 78, 716-721. 

Study Protocol 
 
 
 
 
 
 
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 
Roelofs, T., Merkens, N., Roelofs, J., Bronkhorst, E. and Breuning, H. (2016). 
A retrospective survey of the causes of bracket- and tube-bonding failures. The 
Angle Orthodontist, 87, 111-117. 
 
Safar Ali, Z.N.J., Geramy, A., Heidari, S. and Ghadirian, H. (2021). Shear 
bond strength of APC Plus adhesive coated appliance system to enamel in wet 
and dry conditions: An in vitro study. International Orthodontics, 19, 130-
136. 
 
Schulz, K.F. and Grimes, D.A. (2002). Blinding in randomised trials: hiding 
who got what. The Lancet, 359, 696-700. 
 
Silverstone, L.M., Hicks, M.J. and Featherstone, M.J. (1985). Oral fluid 
contamination of etched enamel surfaces: an SEM study. Journal of the 
American Dental Association (1939), 110, 329-332. 
 
Stefański, T., Kloc-Ptaszna, A. and Postek-Stefańska, L. (2019). Bond 
strength of orthodontic adhesives to dry and saliva-moistened enamel a 
comparative in vitro study. Archives of Materials Science and Engineering, 
96. 
 
Thiyagarajah, S., Spary, D.J. and Rock, W.P. (2006). A clinical comparison 
of bracket bond failures in association with direct and indirect bonding. 
Journal of Orthodontics, 33, 198-204. 
 
Webster, M.J., Nanda, R.S., Duncanson, M.G., Jr., Khajotia, S.S. and Sinha, 
P.K. (2001). The effect of saliva on shear bond strengths of hydrophilic 
bonding systems. American Journal of Orthodontics and Dentofacial 
Orthopedics, 119, 54-8. 

Study Protocol 
 
 
 
 
 
 
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 
Wendl, B. and Droschl, H. (2004). A comparative in vitro study of the strength 
of directly bonded brackets using different curing techniques. European 
Journal of Orthodontics, 26, 535-544. 
 
Wenger, N.A., Deacon, S. and Harradine, N.W.T. (2008). A Randomized 
Control Clinical Trial Investigating Orthodontic Bond Failure Rates When 
Using Orthosolo Universal Bond Enhancer Compared to a Conventional 
Bonding Primer. Journal of Orthodontics, 35, 27-32. 
 
Zachrisson, B.U. (1977). A posttreatment evaluation of direct bonding in 
orthodontics. American Journal of Orthodontics, 71, 173-189. 
 
Zeppieri, I.L., Chung, C.-H. and Mante, F.K. (2003). Effect of saliva on shear 
bond strength of an orthodontic adhesive used with moisture-insensitive and 
self-etching primers. American Journal of Orthodontics and Dentofacial 
Orthopedics, 124, 414-419. 
 

Patient Information Sheet and Consent Form                                                                                                            Ethics Committee 
Page 1 of 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 (to be written by the researcher in a simple language 
answering the following questions when applicable) 
1. Study title: A Clinical Comparison of the Effectiveness of Two Moisture Insensitive 
Primers on Orthodontic Attachment Bond: A Randomized Clinical Trial . 
2. What is the purpose of this study? To find a better Moisture insensitive primer to reduce 
orthodontic attachments bond failure. 
3. Where will the study be conducted? University of Baghdad/college of 
dentistry/orthodontic department . 
4. What are the procedures to be followed and what will you be asked to do at each visit? 
33 participants will be included in the study. In each participant , two teeth will be primed 
using the first primer and other two teeth will be primed using the other primer while the 
rest of the teeth will be primed conventionally then these attachments will be followed up 
for six months. You will be instructed to Report immediately whenever a bond failure 
occurs in the involved attachments. 
5. How long will the participation in the study last? Six months. 
6. If you decided to take part in the study, will the treatment be different from the treatment 
you would get otherwise? No. 
7. Who should not enter the study? If the surface of the target tooth has caries, fillings or 
stressful contact. 
8. What will be the benefits of the study? 
   a) To the participant? The bond materials could reduce bond failures and thus, improve 
the overall treatment for the patient and others. 
   b) To the investigator? To find a better orthodontic bond material that reduce bond failure 
percentage to improve orthodontic treatment and as a Partial Fulfillment of 
Requirements for the Degree of Master of Science in Orthodontics. 
9. What are the possible risks of taking part? There are no risks. 
10. If you feel severe discomfort or pain during the study, would you be able to take any 
relief medication? Yes. (Only Paracetamol). 
11. Will your participation in the study interfere with your daily activities? No. 
12. Will you be informed of the results of the study? Yes if you request it . 
 
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 
Page 2 of 2 
 
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: Ahmed Abdulelah Abduljawad 
Phone No.: +9647705429007 
Email: ahmedabdulelah91@gmail.com 
1 copy for the participant; 1 copy for the researcher