Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts
Phase: NA
Conditions: PRP & Jaw Cysts
Sponsor: Assiut University

Faculty of Medicine 
Institutional Review Board (IRB) 
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Assiut Medical School Research Proposal Form 
Research Proposal Form 
This section is for Official Use Only 
Reference Code: 
 
 
Date of application (dd/mm/yyyy):  
 
 
 
 
This section is for the applicant to fill.  
• Use Times New Romans Font, size 11 and adjust line spacing to 1.5 all through the application form 
• Do not CAPITALIZE all words 
Part 1: General 
Master Degree  
 
 
b. MD  
 
c. Independent Research/Project 
 
1.1 Applicant Name (responsible for all correspondences and accuracy of data):  
Maikel Merit Gerges Morkos 
 
Department: 
General surgery 
 
e-mail address: Michael.16266363@med.aun.edu.eg 
Mobile Phone:  01271267725 
: االسم باللغة العربية مايكل مريت جرجس مرقس  
 
Home Phone:  01091018115 
 
1.2 English Title of research project: 
Role of Platelet Rich Plasma in Bone regeneration after enucleation of odontogenic jaw cysts  
 
1.3 Arabic Title (use the WHO Unified Medical Dictionary): www.emro.who.int/unified-medical -dictionary.html 
 
.دور البالزما الغنية بالصفائح الدموية فى تجديد العظام بعد أستئصال االكياس الفكية السنية  
 
1.4 Do you need funding from Assiut Medical School Grants Office? 
Yes  
 
 
No  
 
 
Mention other sponsoring agent(s) if any: …………………………………………...  

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Assiut Medical School Research Proposal Form 
Part 2: Research Details 
2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the 
problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) 
Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall & curettage  has 
evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using 
of Platelet rich plasma. 
Platelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation 
composed mainly of platelets (platelet-rich plasma gel) 
    applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration. 
An interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical 
sites, may enhance the body’s natural wound healing mechanisms [1]. Platelet-rich plasma (PRP) is the 
accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in 
concentration greater than normally found in peripheral blood 
Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and 
other blood-borne pathogens [2]. A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is 
added to other materials such as collagen, gelfoam, etc. 
 
2.2 Aim(s) of the Research (50 words max): 
in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst  of the jaws 
is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used. 
 
2.3 Research Domain (Faculty Research Plan). 
1. Trauma; epidemiology, prevention, management, and rehabilitation 
2. Communicable diseases; prevention, screening for early detection, and management 
3. Infection control and health-care-associated infections and Safety of medical service providers 
4. Population problem, maternal and perinatal morbidity and mortality 
5. Non-communicable diseases; prevention, screening for early detection, and management 
6. Evidence based management of common medical and surgical problems 
7. Organ Transplantation 
8. Geriatric Health; promotive, preventive, curative and rehabilitative services 
9. Stem cells and/or tissue culture application in managing various diseases in clinical trials 
10. Experimental Research; basic and animal model research that may lead to possible enhancement in health 
services 
11. Others, clarify,------------------------------------------------------------------- 
 
2.4. Research Methods and techniques: 

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2.4.1- Type of the study:  interventional, prospective clinical trials 
2.4. 2- Study Setting: general surgery department  , Assiut university , in the period from 10/2024 to 10/2026 
2.4. 3- Study subjects: 
a. Inclusion criteria:  
1. All patients admitted to AUH with mandibular or maxillary Odontogenic cysts 
2. Size of the cyst more than 2 cm 
3. The lesion could be visualized radiographically 
4. Patients within the age range of 20 to 50 years 
 
b. Exclusion criteria:  
1-Neoblatic lesions 
2- Patients who were alcoholics & smokers 
3-Patients with systemic diseases 
4-History of bleeding tendencies, blood dyscrasia 
5-Low platelet count 
6-  Patients unable or unwilling to return for follow-up 
 
c. Sample Size Calculation: The sample size was calculated using G*power software 3.1.9.4., the 
minimum required sample size is 42 patients ( 21 in each group ) 
based on the 
following assumptions: 
The main outcome variable is the role of Platelet Rich Plasma in Bone regeneration after enucleation of 
odontogenic jaw cysts. Based on previous study (Evaluating the Efficacy of Platelet‐Rich Plasma (PRP) 
in Accelerating Healing and Reducing Complications in Oral Surgery) we expect to find large effect 
size = 1.164 
The main statistical test is t-test to detect the difference between the two groups. 
Two tailed  
Alpha = 0.05 
Power = 0.95 
Effect size = 1.164 
Allocation ratio= 1 
The Parameters : 

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Mean ± SD of The alveolar bone density in PRP  
patients at 6 months postoperative : 141.13±10.81 
Mean ± SD of control group  at 6 months postoperative : 127.91±11.87 
 
2.4.4 –Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): 
• 
Patient history  
 
 history of tooth extraction  
             pain in jaw 
• 
Examination  
 
jaw or maxillary swelling  
• 
Laboratory investigation 
 
Complete blood picture 
 
Coagulation profile 
 
Kidney function 
 
Liver function 
• 
Imaging  
           panorama xray 
           CT teeth 
• 
 Instruments & method  
            Preparation of PRP 
Preoperatively, platelet-rich plasma was prepared in the Haematology Laboratory from 20 ml of the patient’s 
blood using an R8-C Laboratory Centrifuge (Remi Motors Ltd., Mumbai) using an aseptic technique. 
              Armamentarium 
Anticoagulant citrate phosphate dextrose, sterile 10 ml test tubes (2 nos.), sterile pipette, Vacutainer tubes 5 ml 
(2 nos.), 10 ml syringe and 21 gauge needle were used. 
              Procedure 
Twenty millilitres of venous blood is collected from antecubital region with a 20- ml syringe and transferred to 
two test tubes containing 1.4 ml anticoagulant (citrate phosphate dextrose solution) each. (A ratio of 1.4 ml of 
anticoagulant to 10 ml of blood) It is then centrifuged for 10 min at 1,300 rpm. The result is a separation of 
whole blood into a lower red blood cell region and an upper straw colored plasma region 
            Surgical procedure 

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The enucleation of cyst or tumour and any further treatment to eliminate pathology was performed nder local 
anesthesia, or in case of large lesions, treatment was performed under general anesthesia. Affected teeth were 
either removed or treated endodontically. 
In the study group, for Mlling the bony defect PRP gel was used. At the time of application, 1 ml of 10 % 
calcium gluconate was added to the PRP and mixed well. A small cube of Gelfoam was added to the test tube 
to soak load PRP (Fig. 4). The test tube 
      
was left standing for 5 min. A gel formed that was placed inside the defect .  Primary wound closure was 
performed. 
           Postoperative follow-up : after one month, three months & six months  
 
2.4.5 –Research outcome measures: 
a. Primary (main): 
                                1 infection   
                                2.bone healing 
b. Secondary (subsidiary): 
                           1 operation time 
                           2  hospitalization time 
                           3 Recurrence 
 
 
2.5-Data management and analysis (Details needed): 
Data collection : data will be collected in patient sheet. 
Computer software : Microsoft Office, SPSS statistical program 
Statistical tests :: Data will be managed by Microsoft Excel, Statistical analysis of the data will be Performed using 
SPSS_22 software package, Data will be presented in the form of frequency and percent, Studied groups will be 
evaluated by analysis of variances. 
 
2.6-References (max. 15) and written in Vancouver style: 
1. Doiphode AM, Hegde P, Mahindra U, Santhosh Kumar SM, Tenglikar PD, Tripathi V. Evaluation of the 
efficacy of platelet‐rich plasma and platelet‐rich fibrin in alveolar defects after removal of impacted bilateral 
mandibular third molars. J Int Soc Prevent Communit Dent 2016;6:S47‐52. 
2. Hanif M, Sheikh MA. Efficacy of platelet rich plasma (PRP) on mouth opening and pain after surgical 
extraction of mandibular third molars. J Oral Med Oral Surg 2021;27:9. 
3. Tiwari A, Gupta N, Singla D, Swain JR, Gupta R, Mehta D, et al. Artificial intelligence’s use in the diagnosis of 
mouth ulcers: A systematic review. Cureus 2023;15:e45187. doi: 10.7759/cureus.45187. 
4. Intini G. The use of plateletrich plasma in bone reconstruction therapy. Biomaterials 2009;30:4956‐66. 

Faculty of Medicine 
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Assiut Medical School Research Proposal Form 
5. Tiwari A. A traumatic ulcer caused by accidental lip biting following topical anesthesia: A case report. Cureus 
2023;15:ee38316. doi: 10.7759/cureus.38316. 
6. Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, et al. Plateletrich fibrin (PRF): A 
secondgeneration platelet concentrate. Part I: Technological concepts and evolution. Oral Surg Oral Med Oral 
Pathol Oral Radiol Endod 2006;101:e37‐44. 
7. Tiwari A, Kumar A, Jain S, Dhull KS, Sajjanar A, Puthenkandathil R, et al. Implications of ChatGPT in public 
health dentistry: A systematic review. Cureus 2023;15:e40367. doi: 10.7759/cureus.40367. 
8. Rathore A, Tiwari A, Nazim M, Gupta AK, Gande M, Krishnakumar J. Detection of human papillomavirus 
and its association with potentially malignant disorders and oral squamous cell carcinoma: A retrospective study. 
J Pharm Bioallied Sci 2022;14(Suppl 1):S820‐4. 
9. Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Plateletrich fibrin as an adjunct to palatal wound healing 
after harvesting a free gingival graft: A case series. J Indian Soc Periodontol 2014;18:399‐402. 
 
 
Part 3: Ethical Considerations (Written in detail taking into consideration the items below): 
 
3.1. Risk – benefit assessment: 
As the study is observational, there are no additional risks to the patients other than the recognized risks of 
their standard care. 
3.2. Confidentiality (dealing with data and data dissemination should be confidential). 
The confidentiality of all participants admitted to this study will be protected to the fullest extent possible. The 
study participants will not be identified by name in any report or publication resulting from data collected in 
this study. 
3.3. Statement describing the research procedure to be given to the participants. 
Ethical aspects whether substantial or procedural will be implicated in this study. Before participants are 
admitted in this study, the purpose and nature of the study as well as the risks will be explained to their parents. 
The participants and/or their parents must agree that he/she understands the investigational nature of the study, 
its inherent risks and benefits, his/her rights to terminate participation in this study without affecting his/her 
rights in having proper health care in the study site, whom to contact with questions regarding the study and 
that he/she is freely given an informed consent to participate in this study 
3.4. Informed consent. 
Informed written or oral consent of the patients will be acquired before participation in the study. 
3.5. Other ethical concerns: 
- The research should be conducted only by scientifically qualified and trained personnel. 
- The research should be based on relevant pre-clinical investigations in animals. 
- The detailed consent form must be inserted here in the proposal. 
إقرار بالموافقة على المشاركة فى البحث. 

Faculty of Medicine 
Institutional Review Board (IRB) 
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Assiut Medical School Research Proposal Form 
....................................... أقر انا  
 
/ بانني اطلعت على بيان مفصل عن البحث المقدم من الطبيب ط م مايكل
مريت جرجس مرقس      
 وانه قد تم اطالعى على الهدف من هذه الدراسة واستراتيجية الدراسة كاملة كما وردت فى استراتيجية البحث مع ذكر احتماالت المتاعب 
التى قد يرد حدوثها من الدراسة وانه سوف ال يترتب على عدم موافقتى على االشتراك فى البحث حجب اى خدمة طبيه عنى 
لقد قرات المعلومات السابقة او قرئت عليا وكانت لى الفرصة السؤال عما اريد وتم اجابة اسئلتى جميعها وبما ارضانى 
واوافق بكامل اختياري على المشاركة فى هذه الدراسة و افهم انه من حقى التوقف عن المشاركة فيها في اى وقت الحق دون أن يؤثر ذلك 
على الخدمة الكلية المقدمه لى 
................................................. توقيع المريض المشارك فى البحث  
...................................................................................  العنوان 
.................................................................................. التاريخ 
 
 
Part 4: Funding (Mandatory for those requesting funding from Grant Office) 
4.1. Total funds requested:                                                  LE 
 
4.2. Author responsible for managing the budget/grant (Cannot be a resident): 
Name 
 
Department 
 
e-mail 
 
Mobile 
 
 
4.3. Budget Details 
Cost 
▪ Research equipment and accessories 
 
▪ Chemicals/Medications 
 
▪ Data entry 
 
▪ Statistical analysis 
 
 
4.4. All researchers’ International publications in the last 3 years.  
 
Title 
Journal 
Impact 
Factor 
1 
 
 
 
2 
 
 
 
3 
 
 
 
4 
 
 
 

Faculty of Medicine 
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(Add others if required) 
4.5. Details of Previously Obtained Grants (institutional or others): 
 
Title 
Name of 
Applicant for 
grant 
Date 
obtained 
Finished 
Yes/No 
Published 
Yes/No 
1 
 
 
 
 
 
2 
 
 
 
 
 
3 
 
 
 
 
 
4 
 
 
 
 
 
(Add others if required) 
 
 

Faculty of Medicine 
Institutional Review Board (IRB) 
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Assiut Medical School Research Proposal Form 
4.6. Research reporting timetable (Mandatory if applying for a fund): 
Activity 
(Other activities may be added) 
Time required (Months) 
2 
4 
6 
8 
10 
12 
14 
16 
18 
20 
22 
24 
Preparation and development of Material 
 
 
 
 
 
 
 
 
 
 
 
 
Training of personnel involved in the research (if 
needed) 
 
 
 
 
 
 
 
 
 
 
 
 
Research work (Clinical, lab work or field work) 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry and analysis 
 
 
 
 
 
 
 
 
 
 
 
 
Research writing 
 
 
 
 
 
 
 
 
 
 
 
 
Publication 
 
 
 
 
 
 
 
 
 
 
 
 
* Numbers indicates the time in months needed to complete each part of the project.  
* Please half squares corresponding to time required for each specific action 
 
 يتعهد الباحثون بنشر نتائج البحث الممول من وحدة تمويل األبحاث فى إحدى الدوريات العلمية
المحكمة والمدرجة على قاعدة Scopus 
 أوWeb Of Science
 
 فى خالل الفترة الزمنية
 المحددة فى البند السابق من قبلهم واال يتم خصم مبلغ التمويل من مرتباتهم بالتساوى فيما بينهم
 .كما يتعهدوا باإلشارة الى مساهمة وحدة تمويل األبحاث بكلية طب أسيوط عند نشر البحث 

Faculty of Medicine 
Institutional Review Board (IRB) 
Assiut Medical School Research Proposal Form 
 
 
 
 
 
 
 
 
10 
Part 5 – Declaration (Name in printed letters): 
I / we (all investigators) certify that, to the best of our knowledge and after reasonable inquiry, the information contained in 
this application, and any supporting documents provided with this application, are correct and complete, and that this 
research has not been conducted or published before. 
يتعهد الباحثون بنشر نتائج البحث الممول من وحدة تمويل األبحاث فى إحدى الدوريات العلمية المحكمة والمدرجة على قاعدة Scopus 
 أوWeb Of Science
 
 فى خالل الفترة الزمنية المحددة فى البند السابق من قبلهم واال يتم خصم مبلغ التمويل من مرتباتهم بالتساوى
 .فيما بينهم كما يتعهدوا باإلشارة الى مساهمة وحدة تمويل األبحاث بكلية طب أسيوط عند نشر البحث 
Authorship Responsibility (Add more authors if required) 
 
Title Name 
Role** 
e-mail 
Phone 
Department 
Signature 
1 Prof 
Samy Mohamed Osman Masoud 
1.1 
2.2 
3.4 
samyosman@aun.edu.eg 
0100151964
2 
General 
surgery  
 
2 Prof 
Diaa El-Din Saber Ahmed 
1.3 
2.1 
3.1 
dr.diaasaber@gmail.com 
0100796794
6 
General 
surgery  
 
3 Prof 
Ahmed Abdo Gad Yousuf 
1.2 
2.2 
3.3 
ahmeddeek2020@aun.edu
.eg 
0109710455
0 
General 
surgery  
 
4 Resi
dent  
Maikel Merit Gerges Morkos 
1.2 
2.1 
3.1 
Michael.16266363@med.
aun.edu.eg 
0127126772
5 
General 
surgery  
 
5  
 
 
 
 
 
 
**Choose at least 1 from each of the 3 groups below 

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11 
Group 1 
Group 2 
Group 3 
1.1- Conception and design 
1.2- Acquisition of data 
1.3- Analysis and interpretation of data 
2.1- Drafting of the submitted protocol 
2.2-Critical revision of the submitted protocol for important intellectual content 
3.1- Statistical analysis 
3.2- Obtaining funding 
3.3- Administrative, technical, or material support 
3.4- Supervision 
3.5- Other (specify) 
 
After completing the application form, please 
1. Record the completed and revised application form on a CD and present to the Vice Dean Research Office. 
2. All authors should sign a printed copy of the completed application form that should be presented as well to the Vice Dean Research Office. 
3. A copy of the printed and signed research application form should be presented to the Ethical Committee. 
4. It is the applicant responsibility to make sure that the application form is fully and accurately completed and that all other supporting documents or formalities are 
completed in due time.