Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis
Phase: NA
Conditions: Cryotherapy
Sponsor: Gulf Medical University

 
 
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NCT number: NCT05722704 
 
Official title: Effect of Cryotherapy on Post-endodontic Pain 
 
ID: IRB/COD/STD/14/May-2022    
 
Date: November 13, 2024 
 
 
 

 
 
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FORMAT FOR SUBMISSION OF RESEARCH PROPOSAL  
 
Title: Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients 
with Symptomatic Apical Periodontitis 
 
1 
Student   
Name(s) & Registration number(s):  
 
Lana Walid Almasoud 
2021MdsEndo01 
 
 
Programme: MDS of dental surgery in Endodontics. 
2 
Supervisor  
 
Name: Dr. Bassem Mohamed Eid. 
Designation: Associate professor of endodontics 
Department: Restorative Dentistry Department  
3 
Co-supervisor (s) 
Name1:  Dr. Tarek Elsewify   
Designation:  Associate professor of endodontics 
Department: Restorative Dentistry Department 
4 
Name (s) of collaborating 
Institution/Department (s) 
 
Enclose permission letter (s) 
Gulf Medical University, Thumbay Dental hospital 
 
 
 
Signature of Student(s) -      ____________________________; _____________________________; 
_____________________________; ______________________________;_____________________ 
 
 
Signature of Supervisor -  
 _________________________ 
 
Signature of Co- Supervisor -  
1 ________________________ 
 
Signature of Co- Supervisor -  
2 ________________________ 
 
Signature of Statistician - 
  _________________________ 
 
 
I have gone through the research proposal. The study has been designed to obtain only information relevant to 
the project and no ethical issues have been identified. 
 
Signature of the Head of the Department/Dean:-___________________________________________

 
 
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Proposal format 
 
1. Title: Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in 
Patients with Symptomatic Apical Periodontitis 
2. Background  
 
 
 
 
  
Post-operative pain is one of the common sequelae after root canal treatment.  Pain is 
triggered by the periapical inflammatory response (1), whose etiology could be mechanical, 
chemical, and/or microbial (2). This periapical inflammation is referred to as apical 
periodontitis (3) The prevalence of pain following root canal treatment has been reported to 
range from 3% to 58%, lasting for several hours or days (4).   
Pain could have a deteriorative effect on the patient’s quality of life and its 
management is an integral part of treatment. Several strategies have been presented in 
endodontics for managing post-endodontic pain such as prescribing analgesics, various 
mechanical techniques, occlusal reduction (5), and cryotherapy. This research will focus on 
occlusal reduction and cryotherapy.  
Various studies have been performed to evaluate the effects of occlusal reduction on 
the treatment of pain and discomfort (5-7).  However, whether it is an effective intervention in 
the management of post-operative pain after root canal therapy remains controversial. 
Although a study by Rosenberg et al. showed that it reduced pain (5) other researchers did not 
find significant differences in the patients' post-procedural pain (6,7).  
Cryotherapy is a treatment in which a particular body segment is exposed to cold 
temperatures. It aims to decrease the targeted tissue temperature to promote healing and aid in 
other therapeutic effects such as diminishing edema, inflammation, and pain. Cryotherapy 
used in dentistry has shown a role in decreasing pain after periodontal surgeries, extractions, 
and implant surgeries (8). In 2015, intra-canal cryotherapy was introduced in the endodontic 
field as a successful treatment in reducing post-endodontic pain (9). Cryotherapy in 
endodontics is applied in the form of applying a final cold irrigating solution into the canal. 
Several studies demonstrated that there was a significant reduction in post-endodontic 
pain after cryotherapy (10-12). Currently, there is no study comparing the effects of 

 
 
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cryotherapy application and occlusal reduction.  Therefore, this study will evaluate the effects 
of cryotherapy applications on post-operative pain on root canal-treated teeth with 
symptomatic apical periodontitis in comparison to occlusal reduction.  
The null hypothesis assumes that there is no difference in the intensity of post-
endodontic pain between the control, occlusal reduction, and cryotherapy groups in patients 
with symptomatic apical periodontitis. Whereas the alternative hypothesis assumes that the 
intensity of post-endodontic pain will be less in the cryotherapy group than in the occlusal and 
control group in patients with symptomatic apical periodontitis. 
 
3. Research Question: Is there is a difference in post-endodontic pain intensity following 
using ccryotherapyy or occlusal reduction in patients with symptomatic apical periodontitis on 
mandibular first molars? 
 
 
4. Rationale:  
 
Pain can have an effect of diminishing quality of life regardless of its type and source. 
When pain is ongoing, it will produce anxiety and emotional distress. Therefore, pain 
management during treatment is an essential aspect. This study aims to establish if 
postoperative pain after root canal treatment can be prevented by the application of 
cryotherapy greater than occlusal reduction. If pain is prevented, the need for analgesics and 
patient’s distress is reduced.  
5. Objectives:   
To compare the intensity of post endodontic treatment pain following final rinse using 
cold saline in comparison to room temperature saline and occlusal reduction. 
 
 
6. Conceptual/Operational definitions: 
• Dependent factors: Intensity of post-endodontic pain 
• Independent factors: Occlusal Reduction, Cryotherapy (cooled saline final irrigant), 
and room temperature saline. 
 
• conceptual definitions 

 
 
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- 
Post-endodontic pain: highly unpleasant sensation caused following root canal 
procedures. 
- 
Occlusal reduction: a procedure in which occlusal interferences are removed using 
articulating paper, occlusal contacts are highlighted and grinded. 
- 
Cryotherapy: the use of extreme cold in surgery or other medical treatment. Final 
cold irrigating solution is placed in a refrigerator at 2.5C and applied to the canal. 
 
 
7. Materials & Methods 
 
 
 
 
7.1. Research design 
The research design will be a prospective randomized controlled clinical trial. The 
patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 
3. The resultant number will determine in which group are the participants to be placed. 
Single blinding will be maintained in this study as patients will not be aware of their 
group/used irrigant.  
 
7.2. Study population 
The study population consists of 60 participants, aged 18–70 years, who will sign the 
informed consent.  The number of participants is chosen according to a previous study (12).  
 
Inclusion criteria 
1.  Age: 18–70 years  
2. A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis  
3.  require endodontic therapy  
4. Mandibular first molars that are diagnosed with symptomatic irreversible 
pulpitis/acute apical periodontitis  
5. Healthy patients without systemic disease  
6. Permanent mature first mandibular molars 
 
Exclusion criteria 
1. Medically compromised patients 

 
 
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2. Pregnant patients  
3. Teeth with incomplete apex formation  
4. Teeth with calcified canals  
5. Periapical abscess  
6. Patients on antibiotic therapy  
7.3. Sample size calculation 
The study will be conducted on 60 patients: with 20 first mandibular molars in each group 
(n=20). The number of participants is chosen as per a previous study by Western et al. (12).  
 
Group I (control group): normal room temperature saline irrigation protocol without occlusal 
reduction  
Group II (occlusal reduction group): normal room temperature saline irrigation protocol with 
occlusal reduction  
Group III (cryotherapy group): final irrigation with cold saline (2.5C-4C) without occlusal 
reduction  
 
7.4. Study settings 
Out-patient clinic, MDS Endodontics postgraduate clinics, Thumbay Dental Hospital 
 
7.5. Sample size estimation: 
Sixty healthy patients 
 
 
 
 
 
 
7.6. Duration of study 
The proposed research will be conducted over a period of 12 months. Details are given in the 
Gantt chart.  
 

 
 
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7.7. Study instrument & validation procedure 
• Post-endodontic pain will be measured by a visual analog scale (VAS) from 1 to 10.  
• The temperature of the cold saline should be 2-4 °C. The saline will be placed in a 
refrigerator with a thermometer sensor to confirm the 2 to 4°C temperature range.    
• After removal, the temperature of the cold saline will be preserved by keeping the 
irrigation syringes in a special box filled with ice with a thermometer.  
• The thermometer will be calibrated according to the manufacturer's instructions.  
 
7.8. Ethical issues 
The proposal will be submitted to the Institutional Review Board of Gulf Medical 
University Ajman, UAE. After obtaining the approval the research will be conducted. The 
confidentiality, anonymity, and privacy of the members will be kept up with.  
The patient will be asked to sign a printed consent form explaining the aim of the 
study and to fill the pain scale chart postoperatively at 6, 24, 48, 72 hours, and 7 days, after 
root canal treatment and return it to the operator at day 8.  
 
7.9. Methodology 
Sample selection:  
The study will be conducted on 60 first mandibular molars; with 20 first mandibular 
molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that 
will contain a number from 1 to 3. The resultant number will determine in which group are the 
participants to be placed. Double blinding will be maintained in this study as the operator and 
the patients will not be aware of their group/used irrigant.  
Group I (control group): normal room temperature saline irrigation protocol without occlusal 
reduction  
Group II (occlusal reduction group): normal room temperature saline irrigation protocol with 
occlusal reduction  
Group III (cryotherapy group): final irrigation with cold saline (2.5 C°- 4 C°) without occlusal 
reduction  
 
Procedural steps: 

 
 
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1) Vitality will be assessed using cold tests and electric pulp testing before the procedure is 
carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical 
health. In order to ensure that the cold and electrical pulp tests are working, and a response is 
elicited, both tests will be carried out on patients not included in the study. 
2) All the patients will receive local anesthesia:  2% lidocaine with 1:100,000 epinephrine.  
 
3) Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using 
a round bur (no.4) and tapered fissure diamond bur (NO173) under copious water.  
4) After removal of coronal pulp tissues using a sterile excavator, the working length will be 
determined with stainless steel hand K-files size #10 and the use of an apex locator and 
confirmed using intraoral periapical radiographs.  
5) Hand instrumentation till 15 size K file.  
6) All the canals will be prepared using Protaper Gold rotary files till the file F2 (20/0.06) 
using the X-Smart Plus endodontic motor.  
 7) Apical patency will be maintained throughout the shaping procedure using the #10 file 
between each instrument. 
8) All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the 
whole preparation procedure. 
9) After completion of cleaning and shaping in groups I and II, all the canals will be flushed 
with a final rinse of saline and dried using appropriate size paper points and obturated using 
the appropriate technique by gutta percha, and permanent composite restoration will be given.  
10) After completion of cleaning and shaping in group III, 20 ml cryo-treated saline 
maintained at a temperature of 2°C–4°C will be irrigated for 5 min in each canal. 
11) All the participants will receive a sheet containing VAS after the procedure. After 6, 24, 
and 48h, patients are to record the intensity of pain in the area of the root canal (using VAS 

 
 
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from 1 to 10). Analgesic pills that had been taken by the patient are to be recorded on the 
patient’s  
7.10. Feasibility of the proposed research 
The study material and methods technique are available and feasible in Thumbay Dental 
Hospital.  
7.11. Details of data storage 
The data gathered from this research will be securely stored in Thumbay Dental 
Hospital. Preoperative data for each patient will be recorded in the predesigned patient's chart, 
which includes age, sex, and tooth number before the treatment.  
  
7.12. Data analysis 
Data obtained will be tabulated and statistically analyzed by the SPSS software to 
compare the effect of cryotherapy and occlusal reduction on the level of post-endodontic pain. 
Patient characteristics will be assessed using numbers, percentages, and mean scores for pain 
severity. Regarding the type of further statistical test, the decision will be taken later after 
discussion with the biostatistician regarding the best method for data analysis.  
 
7.13. Timeline 
Responsibility 
Phases 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Supervisor meeting 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of thesis protocol to 
obtain the Ethics approval 
 
 
 
 
 
 
 
 
 
 
 
 
Revising the protocol if necessary. 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
Writing a draft thesis 
Submission of completed thesis for 
approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Presentation of thesis 
 
 
 
 
 
 
 
 
 
 
 
 
Make changes if needed as per the 
advice of the Committee 
 
 
 
 
 
 
 
 
 
 
 
 
Submit thesis along with submission 
form to the university and copies to 
the department and library 
 
 
 
 
 
 
 
 
 
 
 
 
Defense 
– 
Thesis 
Evaluation 
Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. Expected outcome:  
the research is expected to reveal the following: 
●  Compare the effect of cryotherapy and occlusal reduction on postoperative pain after 
root canal treatment in patients with acute symptomatic periodontitis.  
 
8. References  
1. Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic 
therapy. Int J Biomed Sci. 2014;10(4):243-247. 
2. Berman L, Hargreaves K, Rotstein I, Cohen S. Cohen's pathways of the pulp. 12th ed. 
St. Louis: Elsevier; 2021. 
3. Siqueira JF, Jr., Rocas IN, Favieri A, Machado AG, et al. Incidence of postoperative 
pain after intracanal procedures based on an antimicrobial strategy. J. Endod. 2002 
Jun;28(6):457–460. [PubMed] [Google Scholar] 
4. Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in 
single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 
41:91–9.  
5. Rosenberg PA, Babick PJ, Schertzer L, Leung A. The effect of occlusal reduction on 
pain after endodontic instrumentation. J Endod 1998; 24:492–6.  
6. CreechJL3rd, Walton RE, Kaltenbach R. Effect of occlusal relief on endodontic pain.  
J Am Dent Assoc 1984; 109:64–7. 
7. Jostes JL, Holland GR. The effect of occlusal reduction after canal preparation on 
patient comfort. J Endod 1984; 10:34–7 

 
 
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8. Laureano Filho JR, de Oliveira e Silva ED, Batista CI, Gouveia FM. The influence of 
cryotherapy on reduction of swelling, pain, and trismus after third-molar extraction: a 
preliminary study. J Am Dent Assoc 2005; 136: 774-8.  
9. Vera J, Ochoa-Rivera J, Vazquez-Carcano M, et al. Effect of intracanal cryotherapy on 
reducing root surface temperature. J Endod 2015; 41:1884–7. 
10. Gundogdu EC, Arslan H. Effects of various cryotherapy applications on postoperative 
pain in molar teeth with symptomatic apical periodontitis: a preliminary randomized 
prospective clinical trial. J Endod 2018; 44:349–54.  
11. Keskin C, Sariyilmaz E, Kelesx A, et al. Effect of intracanal cryotherapy on the 
fracture resistance of endodontically treated teeth. Acta Odontol Scand 2019; 77:1647.  
12. Western J, Zahir A, Haja Mohainuteen A, Ping B, Hui C, Ru C et al. Intracanal 
cryotherapy with two different temperature ranges in reducing postendodontic pain: A 
double-blind randomized clinical trial. Saudi Endod J. 2022;12(1):82. 
13. Chauhan S, Jain A, Bahuguna R, Agarwal A, Sharma R, Khan F. Effect of cryotherapy 
on postoperative pain: Randomized controlled trial. Indian J Dent Sci. 2021;13(4):236. 
14. Jain A, Davis D. Role of Cryotherapy in Reducing Postoperative Pain in Patients with 
Irreversible Pulpitis; An In-Vivo Study. Inter. J. Dent. Med. Sci. Res. 2018;2(10):43-46. 
9. Consent form 
 
 جامعة الخليج،الطبية عجمان ، اإلمارات العربية المتحدة 
نموذج الموافقة 
العنوان:
 
.  
 تأثير العالج بالتبريد والحد من اإلطباق على آالم ما بعد
 اللبية لدى مرضى التهاب دواعم السن 
 
 :الباحث النا النسعود 
:المشرف د. 
 باسم محمد عيد 
 
المشرف المشارك :
 د. طارق السويفى 
 
 
 :موقع الدراسة
مستشفى ثومبي لالسنان عجمان 
 
:رقم االتصال +971 67431333
 
 .نسعى جاهدين للحصول على موافقتك للمشاركة في البحث
Gulf Medical University, Ajman, UAE 
CONSENT FORM 
 
Title: 
Effect 
of 
Cryotherapy 
and 
Occlusal 
Reduction on post-endodontic pain in patients with 
Symptomatic Apical Periodontitis 
 
Investigator: Dr. Lana Walid 
Almasoud…………….. 
 
Supervisor: Dr. Bassem Mohamed Eid. 
Co-Supervisor: Dr. Tarek Elsewify   
 
 
Study site:   Thumbay Dental hospital, Ajman. 
 
Contact Number: +971 67431333  
Your consent is being sought to take part in the 
research. Please read the following instructions 
carefully before making the decisions whether to 

 
 
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 يرجى قراءة التعليمات التالية بعناية قبل اتخاذ القرار بشأن
 .الموافقة على المشاركة أم ال 
 
القسم األول: مقدمة 
  أقوم  أنا  الدكتورة  النا،المسعود  
 طالبة  السنة  الثانية  في
  البرنامج  ماجستير  جراحة  اللبية،  جامعة  الخليج ،الطبية 
،  عجمان  
:بإجراء  بحث  
 تأثير  العالج  بالتبريد  والحد  من
 اإلطباق على آالم ما بعد اللبية لدى مرضى التهاب دواعم
السن  تحت إشراف األستاذ لدكتور ب
اسم محمد عيد . يعتبر
 هذا  البحث  جزء  من  المقرر  الدراسي.  سيتم  إجراء  هذا
 البحث على شريحة من المرضي االصحاء الذين يحتاجون 
معالجة قناة الجذر. 
 سيتم تزويدك بمعلومات مفصلة في 
حال موافقتك للمشاركة في البحث. 
 
 
 فضال
ال تتردد 
 في أن تسألني إذا كان أي سؤال أو كلمة غير
 واضحة، أو إذا شعرت بعدم الراحة في أي لحظة أو كانت
  لديك أي شكوك بشأن،البحث  
 فيمكنك إيقافي في أي وقت
 .للتوضيح. يمكنك أيضًا االنسحاب من الدراسة في أي وقت
 برجاء العلم بأن قرارك فيما إذا كنت ترغب في المشاركة أم
ال هو عمل تطوعي تمامًا . 
 
 
 
 
القسم الثاني: تفاصيل الدراسة 
 :الغرض من البحث 
 
 
 سيتم إجراء هذا البحث للتحقيق في: 
 هدف هذا البحث إلى
 تقييم آالم ما بعد الجراحة بعد الري النهائي باستخدام محلول
 بارد بالمقارنة مع تقليل اإلطباق 
  
 
 
لماذا يطلب مني المشاركة في هذا البحث؟ 
 
 ، ستضيف مشاركتك قيمة ألبحاثنا، حيث يهتم هذا البحث
بشكل أساسي بالتحقيق في 
 تأثير العالج بالتبريد على آالم ما
بعد الجراحة مقارنة بتقليل اإلطباق 
 
 
 كم من الوقت ستسغرق هذه الدراسة؟ 
حوالي 
 أسبوع واحد 
 كم عدد األشخاص اآلخرين الذين سيشاركون في هذه
 الدراسة؟ 
٩٦ 
 شخص 
consent to participate. 
 
Section I: Introduction 
I, Dr. Lana Almasoud, student of 2nd year MDS 
endodontics program, at Gulf Medical University, 
Ajman. am conducting research entitled: Effect of 
Cryotherapy and Occlusal Reduction on post-
endodontic pain in patients with Symptomatic 
Apical Periodontitis under the supervisor Dr. 
Bassem Mohamed Eid. 
 
As a part of the curriculum. This research will be 
carried out on healthy individuals indicated for root 
canal treatment. Detailed information will be 
provided to you. Your consent will be sought to 
participate in the research. Upon your acceptance,  
feel free to ask me if any question or word is not 
clear to you. If you feel discomfort at any moment 
or you have any doubts concerning the research, 
you can stop me at any time and ask me to provide 
more details. You can also withdraw from the study 
at any point of time. Your decision on whether you 
want to participate or not is completely voluntary. 
 
Section II: Details of the study 
 
Purpose of the Research: This research is aimed to 
evaluate 
postoperative 
pain 
following 
final 
irrigation using cold saline in comparison to 
occlusal reduction 
 
 
 
 
Why am I being asked to participate in this 
research? 
 your participation will add a value to our research. 
This research is mainly concerned to investigate In 
the effect of cryotherapy on postoperative pain 
compared to occlusal reduction 
 
 
…………………………………... 
 
How long will I be in this study? 
About 1 weeks  
 
How many other people will be participating in 

 
 
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31-Dec-2021 
 
ماذا سيطلب مني أن أفعل؟ 
 قبل أن تشارك في هذه،الدراسة 
 سأطلب منك إعطاء موافقة
 خطية بعد أن أوضح لك الغرض من البحث. سوف أطلب
 منك  المشاركة  في  البحث  بقبول  إجراء  الصور  الشعاعية
،الالزمة  
  وتلقي  عالج  قناة،الجذر  
 وإعادة  المسح  الذي  تم
 .تقديمه لك بعد أسبوع واحد 
 
 ما الفوائد التي يمكن أن أتوقعها من المشاركة في
 الدراسة؟ 
 فائدة المشاركة في الدراسة هي أنك ستحصل على عالج
.مجاني لقناة الجذر 
 
 ما هي المخاطر / المضايقات المتوقعة من المشاركة في
هذه الدراسة؟ 
،نعم 
 قد يكون لعالج قناة الجذر بعض المضاعفات مثل كسر
 األدوات وثقوب األسنان وآالم ما بعد الجراحة 
 
هل هناك تكاليف للمشاركة؟ 
 نحن ال نطلب منك أن تدفع لنا أي مبالغ وكذلك نحن لن ندفع
 لك حيث
إن 
 الدراسة تتضمن إجراء عالجي 
 هل يمكنني المشاركة في هذه الدراسة دون التوقيع على
 نموذج الموافقة؟ 
 سيمنعك رفضك للتوقيع على نموذج الموافقة من المشاركة
 ،في الدراسة. ومع ذلك، إذا وقعت على نموذج الموافقة
 فسيظهر موافقتك على المشاركة في الدراسة وستحصل على
 .نسخة موقعة من نموذج الموافقة 
 
السرية 
 تٌخزن البيانات التي تم جمعها من هذا البحث بشكل آمن في
 مكتب كلية طب  األسنان بجامعة  الخليج الطبية  لمدة ثالث
 .سنوات 
 لن يتم مشاركة أي معلومات عنك قد تكشف عن هويتك بأي
 شكل من األشكال. في أي منشورات أو عروض تقديمية، لن
 يتم  أيضًا تضمين  أي معلومات تجعل من  الممكن  التعرف
 عليك  كمشارك  في  موضوع  البحث  حيث  سيتم  تحليل
 البيانات في مجموعات. ال يمكن الوصول إلى المعلومات إال
 من  قبل  لجنة  األخالقيات  في  الجامعة،  والباحثين  (إذا  لزم
 .األمر) مع التنظيم المناسب 
 
 
 
 القسم الثالث: شهادة الموافقة 
 أقر أنني قد قرأت المعلومات الواردة أعاله وقد أتيحت لي
 الفرصة لتوضيح كاقة شكوكي والرد على أسئلتي بما يتيح
 لي أن أوافق
طوعًا على 
 .المشاركة في هذه الدراسة 
 
this study? 
69 individuals  
 
What I will be asked to do? 
Before you participate in this study, I will ask you 
to give a written consent after explaining to you the 
purpose of the research. I will ask you to participate 
in the research by accepting to perform necessary 
radiographic images, receiving root canal treatment 
and returning back the survey given to you after 1 
week.   
 
What benefits can I expect from participating in 
the study? 
The benefit of participating in the study is that you 
will get a free root canal treatment.    
What possible risks/ discomforts can I expect 
from participating in this study? 
Yes, root canal treatment might have some 
complications such as instrument fracture, tooth 
perforations, post operative pain.   
 
Are there costs for participating? 
We don’t require you to pay us and neither will you 
be paid. 
 
Can I participate in this study if I do not sign 
this consent form? 
Your refusal to sign this consent form will prevent 
you from participating in the study. However, if you 
do sign this consent form, it shows your approval to 
participate in the study and you will receive a 
signed copy of this consent form. 
 
Confidentiality  
The data gathered from this research will be 
securely stored in the office of the college of 
dentistry at Gulf Medical University for a period of 
three years. 
 
We will not share any information about you which 
may disclose your identity in any form. In any 
publications or presentations, any information that 
makes it possible to identify you as a subject will 
not be included. The data will be analysed in 
groups. The information can be only accessed by 
ethics committee in the University, and the 

 
 
Page 14 of 15  
31-Dec-2021 
 
 
 
 
 
 
 
 
 
 
 اسم:المشارك 
 
  :توقيع المشارك 
                                                                           
 :التاريخ 
 بيان من الباحث أخذ الموافقة 
تم تقديم نسخة من نموذج الموافقة المستنيرة إلى المشارك 
 
 :اسم الباحث الذي أخذ الموافقة 
 
:توقيع الباحث الذي يأخذ الموافقة 
 
researchers 
(if 
required) 
with 
appropriate 
regulatory. 
 
Section III:  Certificate of Consent 
I have read the above information. I have had the 
chance to clear my doubts and my questions have 
been answered to my fulfilment. I consent willingly 
to be a participant in this study. 
 
Name of participant: 
 
Signature of participant: 
 
    Date: 
 
Statement by the researcher taking consent 
A copy of this Informed Consent form has been 
provided to the participant  
 
Name of Researcher taking the consent: 
 
Signature of Researcher taking the consent: 
 
 
 
 
 
10. Draft Questionnaire  
 
Postoperative Pain:  
_____6h.                _____24h.                 _____48.               _____72h             _____7 days 
 
0 = no pain  
1-3 = mild pain  
4-6 = moderate pain  
7-9= severe pain  

 
 
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10=worst pain  
 
11. Budget 
• Not available  
 
 
12. Collaborations (If Any) 
1. Two copies (one original & one Xerox) of the research proposals must be sent through 
the Head of the department/Dean to the research department, Gulf Medical University.