Effect of Different Cleaning Regimes on Biofilm Formation of Acrylic Based Removable Orthodontic Appliance
Phase: NA
Conditions: Oral Disease
Sponsor: University of Baghdad

 
 
 
 
 
Effect of different cleaning regimes on 
biofilm formation of acrylic based 
removable orthodontic appliance: 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 
Orthodontic 
 
By 
Safa Imad Khawwam 
B.D.S. 
Supervised by: 
Prof. Dr. Dheaa Hussein Al-Groosh 
B.D.S, M.Sc. (Ortho), Ph.D. (Ortho), AFHEA 
Baghdad-Iraq 
December, 2021

Certification of the Supervisor 
 This is to certify that the preparation and organization of this protocol entitled 
"Effect of different cleaning regimes on biofilm formation of acrylic based 
removable orthodontic appliance: A randomized clinical trial" had been 
made by the master student Safa Imad Khawwam 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. 
 
 
 
 
 
 
 
 
Prof. Dr. Dhiaa Hussein Al-Groosh 
B.D.S., M.Sc. (Ortho), Ph.D. (Ortho), AFHEA 
Department of Orthodontics 
College of Dentistry/University of Baghdad 
2021 
(The Superviser) 
 
 
 
 

Study Protocol 
 
 
 
1 
 
Effect of different cleaning regimes on biofilm 
formation of acrylic based removable orthodontic 
appliance: A randomized clinical trial 
 
Introduction 
        Orthodontic treatment is adopted by wide section of society not only for 
the corrections of malocclusion but also improves mastication, speech and 
appearance, as well as overall health, comfort, and self-esteem (Westley, 
2010). There are two types of orthodontic appliances either removable or fixed 
appliance. Although the orthodontic appliance has many known benefits, 
these appliances are also associated with a number of damages and disorders 
of oral cavity (Pathak and Sharma, 2013). Polymethyl methacrylate 
(PMMA) is the standard material for denture bases because of its 
biocompatibility, low cost, ease of processing, high flexural resistance and 
flexural modulus, and low water solubility (Leão et al., 2018); however, the 
PMMA denture base is susceptible to microbial colonization in the oral 
environment (Puri et al., 2008) other factors that favor microbial colonization 
are porosity, surface roughness, poor denture hygiene, and continual and 
nighttime wearing of dentures (Gendreau and Loewy, 2011). Rougher 
surfaces have been found to be more difﬁcult to clean and promote re-growth 
by surviving organisms as opposed to complete surface re-colonization 
(Teughels et al., 2006).  
       Physiologically the human’s oral microflora consists of a mixture of 
organisms, which are common also to other anatomical districts. This 
bacterial charge is extremely complex, being composed of over 700 different 

Study Protocol 
 
 
 
2 
 
species of bacteria (Relman, 2015). Biofilm is a matrix-enclosed microbial 
accretion that adhere to biological or non-biological surfaces (Hall-Stoodley 
et al., 2004). Bacterial biofilms are serious global health concern due to their 
abilities to tolerate antibiotics, host defense systems and other external 
stresses; therefore it contributes to persistent chronic infections (De la 
Fuente-Núñez et al., 2013). Formation of biofilm is well-regulated multi step 
events such as (i) adsorption of molecules (macro and micro molecules) to 
surfaces; (ii) bacterial adhesion to the surface and release of extracellular 
polymeric substances (EPS); (iii) colony formation and biofilm maturation. 
(Flemming et al., 2007). Patients need to be aware of the implications for 
their oral health when undergoing recommended orthodontic treatment. On 
the other hand, when a patient accepts to undergo orthodontic treatment, 
including those using removable orthodontic devices, he/she should be 
reminded that it entails a commitment to a higher regimen of attention towards 
oral hygiene and health in patient’s home care (Al Makhmari et al., 2017). 
Recently, Rodriguez-Renteria et al. (2021) investigated after 4 weeks the 
frequency of Staphylococcus aureus, Pseudomonas aeruginosa, and Candida 
species on removable orthodontic appliances and found that, of the 55 
removable orthodontic appliances studies, Staphylococcus aureus was present 
on 90.9%, Pseudomonas aeruginosa on 67.7% and Candida species on 32.7% 
of the appliances. Interestingly, these microorganisms were also found in the 
support oral mucosa of the 55 children (89.09%; 60%; 30.9% respectively). 
The authors also concluded a direct relationship between removable 
orthodontic treatment and an increase in the amount of periodontal pathogenic 
microorganisms. Surface roughness, incomplete polymerization, or wear 
caused by daily brushing of the appliance seems to directly influence bacterial 
and fungal biofilm adhesion to removable acrylic appliances. 

Study Protocol 
 
 
 
3 
 
      The denture base after processing is finished using acrylic finishing bur 
and sandpaper and polished using a rag wheel and cone with pumice slurry.       
The surface roughness of the denture base material has a substantial effect on 
plaque adherence and microbial colonization of the prostheses. A rough 
surface creates niches in which microorganisms are protected against 
mechanical dislodging forces. The bacteria can subsequently spread over the 
denture surface from these niches. It has been proven that an increase in 
surface roughness above a threshold of 0.2 μm results in a simultaneous 
increase in plaque accumulation. This concept is of clinical importance 
because patients need to have a smooth surface to deter the formation of a 
biofilm. This is an esthetic concernas well as an overall concern for 
maintaining good oral hygiene. Bollen et al. (2017) found that the surface 
roughness of acrylic resin can be dependent on the polishing grit. 
Streptococcus sanguis, Bacteriodes gingivalis, and Candida albicans adhere 
in very high numbers to roughened acrylic resin versus smooth acrylic resin. 
Al Groosh et al. (2015) investigated the influence of surface roughness and 
surface dynamics on the attachment of Methicillin-Resistant Staphylococcus 
aureus (MRSA) onto orthodontic retainer materials and found that the number 
of bacteria attached to the surface of the tested materials increased over the 48 
h time period regardless of the material chemistry and surface topography. 
There was no significant difference in MRSA biofilm formed on the surface 
of these materials. However, the scanning electron microscope and the 
Confocal laser scanning microscopy showed that the distribution of bacterial 
aggregates increased on the rougher surface of the auto polymerized acrylic 
samples whereas the pattern of bacterial attachment was more uniformly 
distributed on the thermoplastic samples. 

Study Protocol 
 
 
 
4 
 
      Some studies have already been conducted in order to investigate the 
effects of different cleaning protocols for acrylic removable orthodontic 
appliances and may also help to reduce the risk of oral diseases related to 
biofilm growth, some different processes have been described such as denture 
cleaners, enzymatic solutions, chlorhexidine, sodium hypochlorite, or 
homemade solutions containing vinegar or citric acid (Eichenauer et al., 
2011). The two major approaches used for denture cleaning are mechanical 
and chemical methods. Mechanical methods include brushing (using water, 
soap, toothpaste, or abrasives) and ultrasonic treatment. Mechanical cleaning 
with brushes is inexpensive and common, but elderly and disabled patients 
might face difficulties with this method because of poor motor coordination, 
poor dexterity, and low motivation. There is evidence that mechanical 
cleaning with toothpastes can result in significant wear of conventional acrylic 
resins. Chemical method includes immersion of dentures in different 
cleansing solutions. Immersion in cleansing solution is an inexpensive, easy, 
and comfortable alternative procedure. Moreover, the cleansing solution can 
reach undercuts of the denture base that are difficult to clean mechanically, 
resulting in more efficient cleaning (Schwindling et al.,2014). 
    No study is conducted to evaluate the most effective method used to remove 
biofilm from removable orthodontic appliance. 
Research question: 
What is the most effective method of cleaning an acrylic based removable 
orthodontic appliance? 
Research hypothesis 
The null hypothesis: There is no difference between the different methods of 
cleaning acrylic based removable orthodontic appliances. 
 

Study Protocol 
 
 
 
5 
 
Aims of the study:  
The aims of the current study are: 
1. To evaluate the effects of different cleaning regimes i.e. chemical and 
mechanical on biofilm formation of an acrylic based removable orthodontic 
appliance. 
2. To find out if surface modification i.e. polished acrylic fitting surface, have 
an impact on cleaning the biofilm formation. 
Methodology 
Study design: 
  An in vivo study. 
Setting: 
   It is double-blind, parallel, randomized clinical trial conducted in the 
orthodontic clinic after obtaining the ethical approval from the ethics 
committee of the department. 
Subjects: 
  Orthodontic patient will be selected to wear a removable appliance for the 
study period. 
Sample size: 
  Thirteen orthodontic patients for each group will be selected to wear a 
removable orthodontic appliance for the study period (Lima et al., 2006) and 
will be instructed for the cleaning protocol according to the manufacturer's 
instructions. 
Inclusion criteria: 
• Presence of full upper permanent dentition; 
• Well-aligned teeth or mild crowding (less than 3mm); 

Study Protocol 
 
 
 
6 
 
• No history of sensitivity to any ingredient contained in the cleaning 
materials; 
• Nonsmoker; 
• Caries free. 
Exclusion criteria: 
• Participant taking steroid-based or antibacterial mouthwash or broad-
spectrum antibiotics; 
• Mouth breather;  
• Participant taking medication that reduces salivary flow;  
• Pregnant or lactating female (Albanna et al., 2017). 
All of the study steps were explained to the participants verbally and in 
writing, written informed consent will be obtained from each participant. 
Materials and instruments 
Materials used for orthodontic removable appliance fabrication: 
• Acrylic powder and monomer (Orthocryl, Dentaurum, Ispringen, Germany). 
• 0.7 mm stainless steel wire (Spring hard, Dentarum, Ispringrn, Germany). 
• Adam's plier. 
• Sticky wax. 
• Separating medium. 
• Cutter. 
• Wax knife. 
• Mold material. 
Materials used for cleaning regimes: 
1-Brush (dental or denture brush) with chlorhexidine (CHX) toothpaste. 
2-Chemical cleaning i.e. Lacalut cleaning tablet. 
3-Combination of brushing with CHX toothpaste and cleaning tablet. 

Study Protocol 
 
 
 
7 
 
Materials and equipment used form microbial isolation and 
identification: 
1. Calcium alginate swab. 
2. Calgon ringer solution. 
3. Bijou tube. 
4. Glass beads. 
5. Phosphate buffered saline (PBS). 
6. Anaerobic cabinet. 
7. Vortex machine. 
8. Culture media. 
A. Mitis-Salivarius Agar (MSA): This agar is a commonly used selective 
medium for isolating and quantifying S. mutans in many cariology clinical 
and epidemiological studies (Xiao et al., 2016). 
B. Mannitol salt agar: Is a commonly used selective and differential growth 
medium in microbiology. It contains a high concentration (about 7.5%-10%) 
of salt (NaCl), making it selective for Gram-positive Staphylococcus aureus 
and epidermidis since this level of salt is inhibitory to most other bacteria 
(Bachoon et al., 2008). 
C. Blood agar: is enriched medium used to culture those bacteria or microbes 
that do not grow easily. Such bacteria are called “fastidious” as they demand 
a special enriched nutritional environment as compared to the routine bacteria 
(Sirois, 2020). 
Other materials: 
1- Rubber bowl 
2- Type IV stone 
3- Gloves 
4- Masks 

Study Protocol 
 
 
 
8 
 
5- Plastic petri dish 
Procedure  
Construction of acrylic samples with different surface texture: 
Acrylic samples i.e. tiles of different surface texture will be made. An acrylic 
sheet of 1 mm thickness will be made using a mold with technique as shown 
in figure 3.  
 
 
Figure 1: Acrylic samples made from polished and unpolished acrylic 
sheet. 
    A half of the sheet will be polished using a conventional polishing 
technique until a glossy surface appears, whereas, the remaining will be kept 
without modification. Tiles of 5mm in diameter will be bored using a trephine 
bur on both sides of the acrylic sheets and each set of tiles i.e. the polished 
and unpolished samples, will be color coated from its seated surface.   
Construction of upper removable orthodontic appliance  
    An impression will be taken to the maxillary arch using alginate impression 
material (Hydrogum 5, Zhermack, Badia Polesine, Italy). The negative replica 
is than poured using type IV stone to make a study model. Four metal discs 
(5mm in dimeter and 1.2mm thickness) will be placed on both sides of the 
palate as seen in figure 2; A. 
 
 

Study Protocol 
 
 
 
9 
 
 
Figure 2: Construction of the acrylic based orthodontic appliance. A, 
Study model with acrylic tiles; B, Fitting surface of the acrylic 
removable appliance. 
     The wire framework of the removable appliance will be fabricated using a 
0.7 mm in diameter stainless steel wire (Spring hard, Dentarum, Ispringen, 
Germany) to make Adam's clasps on upper first premolars and molars to retain 
the appliance.  
     After applying a separating medium, an acrylic base will be fabricated 
using the orthodontic acrylic powder and liquid (Orthocryle, Dentaurum, 
Ispringen, German) with a ratio of (2.5 parts powder to 1 part liquid) 
according to the manufacturer's instruction. Before setting, a sprue or chimney 
like structure will be created through the acrylic dough to facilitate the metal 
discs and acrylic sample removal. The appliance then will be removed and the 
metal tiles will be dislodged using metal pin (Figure 2; B).  
    The acrylic tiles (5mm in diameter and 1mm thickness) will be placed and 
fixed into the holes, created by the metal discs, using sticky wax. The acrylic 
samples will be randomly seated as shown in figure 3. 
The appliance will be sterilized using proper sterilization protocol.  

Study Protocol 
 
 
 
10 
 
 
  
Figure 3: The acrylic base containing the acrylic samples. 
 
Method for biofilm detection 
      The removable appliance will be assigned randomly and blindly and fitted 
into the oral cavity of the patient for one week. Each individual will be given 
a pack containing the cleansing pack and an instruction sheet with a web link 
describing the cleaning regimen for his/ her appliance. The packs are similar 
in shape and color and will be prepared by a third person who does not know 
the purpose of the study. The volunteer will be grouped into three groups: 
Group 1: patients will be instructed to brush both sides of the removable 
appliance once a day for 1 minute before bedtime using the toothbrush and 
the CHX toothpaste provided and water (Albanna et al., 2017). 
Group 2: patients will be instructed to immerse the appliance in 150 ml cup 
with tap water and dissolve one cleansing (Albanna et al., 2017) tablet for 20 
minutes according to the manufacture instructions. 
Group 3: Combination of the chemical and mechanical methods first 
submitted to the mechanical method, followed by the chemical method 
(Oliveira et al., 2009). 
      At the end of the study period, the acrylic samples will be removed 
carefully and applied into a petri dish containing PBS via a sterile tweezer.   
The samples will be then immersed twice in a 25ml sterile tubes containing 

Study Protocol 
 
 
 
11 
 
PBS to remove the planktonic bacteria and inserted into 5ml bijou tube 
containing 1mm PBS and 5 sterile glass beads.  The sample will be vortex-
mixed for 1 min to disseminate the biofilm and create a homogenous solution. 
Ten-fold serial dilutions will be carried out in PBS before the samples are 
plated onto blood agar (BA), to give the total anaerobic count, mitis salivarius 
agar (MS), a selective agar for streptococci and Mannitol salt agar (MA) for 
Staphylococci spp. BA and MS plates will be incubated anaerobically for 2-4 
days at 37ºC using anaerobic cabinet whereas the MA will be incubated for 2 
days in aerobic condition. All organisms from both selective and nonselective 
agars will be distinguished by colony morphology and will be characterized 
by Gram reaction (Al Groosh et al., 2011) and other confirmatory tests. 
Confirmatory test  
1. Catalase testing: Catalase is a common enzyme found in nearly all living 
organisms exposed to oxygen (such as bacteria, plants, and animals) 
(Chelikani et al., 2004). This test demonstrates the presence of catalase, an 
enzyme that catalysis the release of oxygen from hydrogen peroxide (H2O2). 
The catalase test is mainly used to differentiate between Gram-positive cocci: 
members of the genus Staphylococcus are catalase-positive, and members of 
the 
genera 
Streptococcus 
and 
Enterococcus 
are 
catalase-negative 
(Whittenbury, 1964).   
2. Coagulase testing: Coagulase is a protein enzyme produced by several 
microorganisms that enables the conversion of fibrinogen to fibrin. In the 
research laboratory, it is used to differentiate between different types of 
Staphylococcus isolates. Importantly, S. aureus is generally coagulase-
positive (Ryan and Ray, 2004). 
 

Study Protocol 
 
 
 
12 
 
Statistical analysis 
  All the data of the tested samples will be collected and analyzed using SPSS 
(statistical package of social sciences). In this study the following statistics 
will be used: 
Descriptive statistics 
• Mean. 
• Standard deviation (SD). 
• Minimum and maximum values. 
• Statistical tables, figures and charts. 
Normality test 
  Data distribution will be tested first using Shapiro-Wilk test to find that 
whether our collecting data are normally distributed or not. 
Inferential statistics 
• ANOVA (if the data parametric) or Kruskal Wallis test (if none parametric) 
to compare the effect of each cleaning agents on biofilm reduction of 
removable orthodontic appliance and Tukey HSD pot hoc test if there is 
significant difference between them. 
• Independent t-test (if the data parametric) or Mann Whitney test (if none 
parametric) to compare the effect of each cleaning agents on biofilm reduction 
on polished and unpolished surface 
   In the statistical evaluation, the following levels of significance will be used: 
Non-significant NS P > 0.05 
Significant S 0.05 ≥ P > 0.01 
Highly significant HS P ≤ 0.01 
 
 
 

Study Protocol 
 
 
 
13 
 
Time table: 
Duty 
Expected time 
Patient Identification and 
allocation 
4 months 
Intervention period 
3 months 
Data 
collection 
and 
analysis 
2 months 
Writing up the thesis 
10 months (starting from the beginning of the 
study) 
Total expected time to 
finish 
About 10 to11 months 
 
 
Budget and Funding: The study is self-funded 
Dissemination: Master Thesis. 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
 
 
14 
 
References 
• Albanna, R.H., Farawanah, H.M. and Aldrees, A.M. (2017) Microbial 
evaluation of the effectiveness of different methods for cleansing clear 
orthodontic retainers: A randomized clinical trial. Angle Orthodontist, 87(3), 
460–465. 
• Al Groosh D.H., Bozec L., Pratten J. and Hunt N.P. (2015) The influence of 
surface roughness and surface dynamics on the attachment of Methicillin-
Resistant Staphylococcus aureus onto orthodontic retainer materials. Dental 
Material Journal, 34(5), 94-585. 
• Al Groosh, D.H., Roudsari, G.B., Moles, D. R. Ready, D., Noar, J. H. and 
Pratten, J. (2011) The prevalence of opportunistic pathogens associated with 
intraoral implants. Letters in Applied Microbiology, 52(5), 501–505. 
• Chelikani, P., Fita, I. and Loewen, P.C. (2004) Diversity of structures and 
properties among catalases. Cellular and Molecular Life Sciences, 61(2), 
192–208.  
• De la Fuente-Núñez, C., Reffuveille, F., Ferna, L. and Robert, E.W. (2013) 
Bacterial biofilm development as a multicellular adaptation: Antibiotic 
resistance and new therapeutic strategies. Current Opinion in Microbiology, 
16(5), 580–589. 
• Flemming, H.C., Neul, T.R. and Wozniak, D.J. (2007) The EPS matrix: The 
House of Biofilm Cells. Journal of Bacteriology, 189(22), 7945–7947.  
• Gendreau, L. and Loewy, Z.G. (2011) Epidemiology and Etiology of 
Denture Stomatitis. Journal of Prosthodontics, 20(4), 251–260.  
• Hall-Stoodley, L., Costerton, J.W. and Stoodley, P. (2004) Bacterial 
biofilms: From the natural environment to infectious diseases. Nature Reviews 
Microbiology, 2(2), 95–108. 

Study Protocol 
 
 
 
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• Leão, R.S., Maior, J.S., Lemos C.A. and Vasconcelos, B. (2018) 
Complications with PMMA compared with other materials used in 
cranioplasty: a systematic review and meta-analysis. Brazilian oral research, 
32(31), 2-4.  
• Lima, E., Moura, A., Del Bel, A., Garcia, R. and Cury, J. (2006) Effect of 
enzymatic and NaOCl treatments on acrylic roughness and on biofilm 
accumulation, Journal of Oral Rehabilitation, 33(5), 356–362. 
• Oliveira, H., Silva-Lovato, C., Raphael, F., Patricia, C., Karina, M., 
Watanabe, E., and Izabel, Y. (2009) Effect of three methods for cleaning 
dentures on biofilms formed in vitro on acrylic resin, Journal of 
Prosthodontics, 18(5), 427–431. 
• Pathak, A.K. and Sharma, D.S. (2013) Biofilm associated microorganisms 
on removable oral orthodontic appliances in children in the mixed dentition. 
Journal of Clinical Pediatric Dentistry, 37(3), 335–340.  
• Puri, G., Berzins, D., Dhuru, V., Raj, P., Rambhia, S., Dhir, J. and Dentino, 
A.R. (2008) Effect of phosphate group addition on the properties of denture 
base resins. Journal of Prosthetic Dentistry, 100(4), 302–308.  
• Sirois, M. (2020) Laboratory procedures veterinary technician. 7th ed. 
China: Elsevier. 222-223 
• 
Whittenbury, 
R. 
(1964) 
Hydrogen 
Peroxide 
Formation 
and 
Catalase 
Activity 
in 
the 
Lactic 
Acid 
Bacteria. 
Journal 
of 
general microbiology, 35(1959), 13–26.  
• 
Xiao, 
J., 
Moon, 
Y., 
Li, 
L., Rustchenko, 
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Wakabayashi, 
H., 
Zhao, X., Feng, C., Gill, S.R., Mclarin, S., Malmstrom, 
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Kopycka-Kedzierawski, 
D.T. 
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Plos one, 11(10), 1–16. 
 

Patient Information Sheet and Consent Form                                                            Ethics Committee 
 
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. 

Patient Information Sheet and Consent Form                                                            Ethics Committee 
 
 
1 
 
Information about the research (to be written by the researcher in a 
simple language answering the following questions when applicable) 
1. Study title: (Effect of different cleaning regimes on biofilm formation of 
acrylic based removable orthodontic appliance: A randomized clinical trial) 
 
2. What is the purpose of this study? 1. To evaluate the effects of different 
cleaning regimes such as chemical and mechanical on biofilm formation of 
an acrylic based removable orthodontic appliance. 2. To find out if surface 
modification i.e. polished acrylic fitting surface, have an impact on cleaning 
the biofilm formation. 
 
3.  Where will the study be conducted? It will be conducted in the orthodontic 
clinic 
 
4. What are the procedures to be followed and what will you be asked to do at 
each visit? Orthodontic patients for each group will be selected to wear a 
removable orthodontic appliance for the study period and will be instructed 
for the cleaning protocol according to the manufacturer's instructions. 
 
5. How long will the participation in the study last? One week 
 
6. If you decided to taking part in the study, will the treatment be different from 
the treatment you would get otherwise? No 
 
7. Who should not enter the study? 
• Participant taking steroid-based or antibacterial mouthwash or broad-
spectrum antibiotics 2 months prior to study participation;  
• Smokers;  
• History of sensitivity to any ingredient contained in the cleaning materials;  
• mouth breather;  
• Patients taking any medication that reduces salivary flow;  
• Caries;  
• crowding (more than 3mm);  
• pregnant or lactating female; and  
• absence of some of the upper permanent dentition 
 
8. What will be the benefits of the study? 
   a) To the participant? Instruction for the participant about the methods for 
cleaning and disinfectant their appliances and obtaining good oral hygiene.   
   b) To the investigator? (This study is a part of fulfillment of the requirement 
for the degree of Master of Science in Orthodontic Department). 
 
9. What are the possible risks of taking part? There is no risk 
 
10. If you feel severe discomfort or pain during the study, would you be able to 
take any relief medication? No 

Patient Information Sheet and Consent Form                                                            Ethics Committee 
 
 
2 
 
 
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 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 
 
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 
 
 
 
 
 
 
 

Patient Information Sheet and Consent Form                                                            Ethics Committee 
 
 
3 
 
 
Name 
Signature 
Date 
Participant 
 
 
 
Parent/guardian 
(if appropriate) 
 
 
 
Person taking 
consent 
 
 
 
Person to contact: 
Name: Safa Imad Khawwam 
Phone No.: 07721417546 
Email: safa.khateeb094@gmail.com 
1 copy for the participant; 1 copy for the researcher