Comparison of Efficacy of Serratiopeptidase and Escin After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial
Phase: PHASE3
Conditions: Impacted Mandibular Third Molar Extraction, Post Operative Complications
Sponsor: University of Science and Technology, Yemen

 
 
 
i
 
 
 
 
 
 
 
 
 
 
 
 
Comparison of Efficacy of Serratiopeptidase and Escin 
after Impacted Mandibular Third Molar Surgery: A 
Randomized Controlled Clinical Trial 
 
A Proposal Submitted by 
Arwa Mohammed Hussien Dahak 
 
To 
The Council of Postgraduate Studies and Scientific Research, in 
Partial Fulfillment of the Requirements for the Master program of  
Dental Sciences in Oral Surgery and Dental Implantology 
 
Supervisor 
Dr. Abdullah Hassan Thabet Farhan 
Assistant Professor of Oral and Maxillofacial Surgery 
Sana’a University
 
 
July, 2024AD 
Sana'a 
Dhul-Hijjah, 1445AH 
 
 

 
 
 
I
 
 
Table of Contents 
Table of Contents .............................................................................................................I 
List of Tables ................................................................................................................... II 
List of Figures ................................................................................................................. III 
List of Appendcies ......................................................................................................... IV 
List of Abbreviations ....................................................................................................... V 
Chapter 1: Introduction ................................................................................................... 1 
1.1. Background ......................................................................................... 2 
1.2. Statement of the Problem ..................................................................... 3 
1.3. Justification of the study ....................................................................... 5 
1.4. Objectives of the study ......................................................................... 5 
1.5. Study Hypotheses ................................................................................ 6 
Chapter 2: Literature Review ............................................................................................ 8 
2.1. Impacted Third Molar ........................................................................... 9 
2.1.1. Etiology of Impaction ....................................................................... 9 
2.1.2. Classification of Impaction ...............................................................10 
2.1.3. Indications and Contraindications for Removal of Impaction ...............10 
2.1.4. Techniques for the Removal of Impacted Third Molars .......................12 
2.1.5. Complications of the Removal of Impacted Third Molars.....................13 
2.2. Post-operative Treatment following Third Molar Surgery. ........................13 
2.3. Split-mouth Randomized Controlled Trials .............................................14 
Chapter 3:    Material and Methods................................................................................. 17 
3.1. Study Design ......................................................................................18 
3.2. Study Population ................................................................................19 
3.3. Sample Size ........................................................................................19 
3.4. Sample Selection.................................................................................20 
3.5. Randomization ...................................................................................21 
3.6. Pre-operative and Post-operative Assessment ........................................22 
3.6.1. Assessment of Pain .........................................................................22 
3.6.2. Assessment of Mouth Opening (Trismus) ..........................................23 
3.6.3. Assessment of Facial Swelling (Edema)..............................................23 
3.7. Surgical Procedures .............................................................................24 
3.8. Ethical Consideration ...........................................................................25 
3.9. Statistical Method ...............................................................................25 
References ................................................................................................................... 26 

 
 
 
II
 
 
 
List of Tables 
Table 2-1 Indications for Removal of Impacted Third Molars. .............................................. 11 
Table 2-2 Contraindications to Extraction of Impacted Third Molars. ................................... 12 
Table 3-1 : Sample Size and Study Treatment. ................................................................... 20 
 
 

 
 
 
III
 
 
List of Figures 
Figure 2-1 Serratiopeptidase vs. Escin: A Comparative Table. .............................................. 14 
Figure 3-1 Pain Intensity Measurement. ..................................................................................... 22 
Figure 3-2 Trismus Measurement - MMOA. ............................................................................... 23 
Figure 3-3 Swelling Measurement. ............................................................................................. 24 
 
 
 
 

 
 
 
IV
 
 
List of Appendcies 
Appendix A: Case Sheet .................................................................................................. 30 
Appendix B: Participant Information Sheet ....................................................................... 32 
Appendix C: Informed Consent Form ................................................................................ 38 
 
 

 
 
 
V
 
 
List of Abbreviations 
 
 
Cone-Beam Computed Tomography
 
CBCT
 
Inferior Alveolar Canal 
IAC 
Maximum Mouth Opening Ability 
MMOA 
Nonsteroidal Anti-inflammatory Drugs  
NSAIDs 
University of Science and Technology, Yemen  
USTY 
Visual Analogue Scale 
VAS 
 
 

 
 
 
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1. Chapter 1: 
Introduction 
 
 

 
 
 
2
 
 
1.1. Background 
The surgical removal of impacted third molars, commonly known as wisdom 
teeth, remains a frequent procedure in oral and maxillofacial surgery. While the procedure 
itself is routine, it often leads to undesirable post-operative complications such as pain, 
trismus (limited jaw opening), and facial swelling (Al-Khateeb & Nusair, 2008; Brković et 
al., 2017). These complications arise from the natural inflammatory response triggered by 
the surgical trauma. 
Traditionally, the management of these complications has relied on 
pharmacological interventions, primarily corticosteroids and nonsteroidal anti-
inflammatory drugs (NSAIDs) (Kaplan & Eroğlu, 2016). These medications offer potent 
anti-inflammatory and analgesic properties, effectively reducing pain and swelling. 
However, their use is often associated with undesirable side effects, including 
gastrointestinal bleeding, renal dysfunction, and blood dyscrasias, raising concerns 
regarding their long-term safety (Piecuch, 2012). Recognizing these limitations, 
researchers have explored alternative therapies with potentially fewer side effects. 
Among these promising alternatives are therapeutic enzymes and phytotherapeutic drugs 
derived from natural sources. 
Serratiopeptidase, a proteolytic enzyme, has emerged as a potential candidate for 
managing post-surgical inflammation. Studies have shown its effectiveness in reducing 
inflammation around teeth and dental implants, suggesting its potential benefit after third 
molar extraction (Sannino et al., 2013; Villafuerte-Nuñez et al., 2013). However, existing 
research in this area remains limited, particularly regarding its efficacy in managing post-
operative complications following third molar teeth removal. 
Similarly, phytotherapeutic drugs offer a promising avenue for post-surgical pain 
and swelling management. These natural extracts have demonstrated their effectiveness 

 
 
 
3
 
 
in treating various inflammatory conditions and postsurgical complications (Olmedo-
Gaya et al., 2016; Pavan et al., 2012). Notably, studies have shown their ability to reduce 
pain and discomfort after third molar surgery, highlighting their potential as safe and 
effective therapeutic options (Isola et al., 2019). One such phytotherapeutic drug, escin, 
derived from horse chestnut, has exhibited potent anti-inflammatory activity, suggesting 
its potential benefit in reducing post-surgical inflammation and swelling (Wang et al., 
2009). 
Despite the promising results observed with both serratiopeptidase and escin, 
significant research gaps remain regarding their specific efficacy in managing post-
operative complications following impacted third molar surgery. Existing studies are 
often limited in scope and methodology, necessitating further investigation to fully 
understand their potential benefits. Therefore, this study aims to address these research 
gaps and provide definitive answers to the study main questions. 
 
1.2. Statement of the Problem 
Impacted third molar extraction is the most commonplace surgical procedure in 
oral surgery (Brković et al., 2017). This surgical procedure results in the most common 
detected post-operative complications which are trismus, swelling, and pain due to the 
inflammatory process (Bataineh & Batarseh, 2017). To treat post-operative complications, 
many strategies have been developed to decrease clinical occurrence after surgery 
through a pharmacological approach by inhibiting inflammatory processes of acute 
inflammation. 
Out 
of 
these, 
corticosteroids 
and 
NSAIDs 
have 
shown 
immunosuppressive, anti-inflammatory, and analgesic effects (Isola et al., 2016; Kaplan & 
Eroğlu, 2016). Though, the use of corticosteroids or NSAIDs has been related to some side 

 
 
 
4
 
 
effects like gastrointestinal bleeding, renal function disturbance, a reduction in platelet 
function, shortness of breath, and profound hypotension (Piecuch, 2012). 
Therefore, researchers have been working on alternative therapies including the 
use of therapeutic enzymes and phytotherapeutic drugs composed of herbal extracts. A 
proteolytic enzyme, serratiopeptidase, has shown positive results in inflammatory 
disorders around teeth and dental implants (Sanninol et al., 2013; Villafuerte-Nuñez et 
al., 2013). So far, published studies assessing the efficacy of serratiopeptidase after third 
molar extraction are minor with inadequate methodological quality (Al-Khateeb & Nusair, 
2008; Chopra et al., 2009; Mouneshkumar et al., 2015).  
In contrast, for many years, many phytotherapeutic drugs have been widely used 
for the treatment of inflammatory diseases and postsurgical conditions (Olmedo-Gaya et 
al., 2016; Pavan et al., 2012). There were favorable effects in the inflammatory 
parameters, when the phytotherapeutic drugs were used as a post-operative therapy of 
third molar surgery, The phytotherapeutic drug as a mixture of herbal extract with anti-
inflammatory activity was shown to be safe and simple in the control of pain and control 
postsurgical discomfort after surgical removal of the third molar. Further studies are 
needed to understand better the role and potential benefits of phytotherapeutic drugs in 
the therapy after the removal impacted third molar (Isola et al., 2019). Escin is a natural 
molecule with a major active component of Aesculus hippocastanum. It is a natural 
mixture of triterpene saponins and has shown clinically considerable anti-inflammatory 
activity postoperatively and in traumatic injuries (Wang et al., 2009). 
Based on the research gaps recommend by (Al-Khateeb & Nusair, 2008; Chopra et 
al., 2009; Mouneshkumar et al., 2015) to assess the efficacy of serratiopeptidase after third 
molar extraction and (Isola et al., 2019) to understand potential benefits of escin after the 
removal impacted third molar, the study aims at finding solid answers to the following 
main questions: 

 
 
 
5
 
 
1. Does serratiopeptidase, when used in addition to conventional drugs, offer greater 
efficacy in reducing post-operative pain, trismus, and facial swelling compared to 
conventional drugs alone following impacted third molar surgery? 
2. Does escin, when used in addition to conventional drugs, offer greater efficacy in 
reducing post-operative pain, trismus, and facial swelling compared to 
conventional drugs alone following impacted third molar surgery? 
3. When both serratiopeptidase and escin are used in addition to conventional drugs 
following impacted third molar surgery, which one demonstrates superior efficacy 
in reducing post-operative pain, trismus, and facial swelling? 
 
1.3. Justification of the study 
There is a high prevalence rate of impacted lower third molars with many 
complications. To the best of the researcher’s knowledge, no clinical study has been 
conducted aiming to compare the efficacy of serratiopeptidase and escin after impacted 
third molar surgery in order to minimize in the most common detected post-operative 
complications. 
 
1.4. Objectives of the study 
Based on the above introduction and study question, the objectives can be 
classified into general and specific as follows:  
 
General objective 
The overall purpose of this study is to compare the efficacy of serratiopeptidase 
and escin in the reduction of post-operative complications (i.e., pain, trismus, and facial 

 
 
 
6
 
 
swelling) following impacted third molar surgery, when both used in addition to 
conventional drugs. 
Specific objective 
1. Evaluate the efficacy of serratiopeptidase, when used in addition to conventional 
drugs, in reducing post-operative pain, trismus, and facial swelling following 
impacted third molar surgery. 
2. Evaluate the efficacy of escin, when used in addition to conventional drugs, in 
reducing post-operative pain, trismus, and facial swelling following impacted 
third molar surgery. 
 
1.5. Study Hypotheses 
Based on the study main problem, objectives, and literature review, three main 
hypotheses are constructed in order to test the relationship between the study variables. 
These hypotheses are listed in this section as follows: 
1. There is a statistically significant difference in serratiopeptidase, when used 
in addition to conventional drugs, in reducing post-operative pain, trismus, 
and facial swelling compared to conventional drugs alone following impacted 
third molar surgery. 
2. There is a statistically significant difference in escin, when used in addition to 
conventional drugs, in reducing post-operative pain, trismus, and facial 
swelling compared to conventional drugs alone following impacted third 
molar surgery. 
3. There is a statistically significant difference in serratiopeptidase in reducing 
post-operative pain, trismus, and facial swelling compared to escin, when 

 
 
 
7
 
 
both used in addition to conventional drugs, following impacted third molar 
surgery. 
 
 

 
 
 
8
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Chapter 2: 
Literature Review 
 
 

 
 
 
9
 
 
2.1. Impacted Third Molar 
The third molars, commonly known as wisdom teeth, often lead to complications 
during eruption, presenting a frequent concern in oral surgery (Wray et al., 2003). (Lytle, 
1979) defines an impacted tooth as “a tooth that has failed to erupt into its normal 
functional position beyond the time usually expected for such appearance. Eruption may 
have been prevented by adjacent hard or soft tissue including tooth, bone, or dense soft 
tissue”. Among impacted teeth, mandibular third molars are the most common, followed 
by maxillary third molars and maxillary canines. Most unerupted teeth are extracted due 
to pain or infection, but other reasons include involvement in pathologies like cysts or 
tumors, causing resorption of adjacent teeth, or interfering with surgical procedures 
(Undrell Moore, 2011). 
 
2.1.1. Etiology of Impaction 
Several theories attempt to explain the cause of impacted wisdom teeth, as 
outlined by (Varghese, 2021). The most widely accepted include: 
1. Disparity in tooth size and arch length: The jaw size may be insufficient 
to accommodate the wisdom teeth, leading to impaction.  
2. Differential root growth: The uneven growth of mesial and distal roots can 
hinder eruption. 
3. Delayed dental development: The wisdom teeth's development may lag 
behind skeletal growth, preventing proper eruption. 
4. Decreased molar extractions: Early dental interventions and increased 
awareness have led to fewer extractions of permanent molars, resulting in 
less space for wisdom teeth. 

 
 
 
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2.1.2. Classification of Impaction 
The core classification system of impacted third molars is the foundation for 
understanding their diverse clinical presentations and facilitating successful transalveolar 
extraction. This system helps categorize impacted teeth based on several key factors, 
outlined by (Bhargava, 2022): 
1. Winter’s classification (developed in 1926) focuses on the angulation of 
the impacted third molar relative to the long axis of the adjacent second 
molar ((Yilmaz et al., 2016). 
2. The Pell and Gregory classification system, proposed in 1933, assesses the 
position of impacted third molars based on two key factors: depth and the 
availability of space (Jaroń & Trybek, 2021). 
3. Rood’s criteria, proposed by Rood and Shehab in 1990, focuses on 
radiographic features indicating a close relationship between the impacted 
third molar and the mandibular canal (Rood & Shehab, 1990). 
4. (Maglione et al., 2015) proposed a classification system specifically 
designed for evaluating impacted third molars using cone-beam computed 
tomography (CBCT) images. 
 
2.1.3. Indications and Contraindications for Removal of Impaction 
Several indications justify the extraction of wisdom teeth, as outlined by (Wray et 
al., 2003) in Table 2-1, including pericoronitis, infection, cystic change, etc. While 
extraction is the common course of treatment, there are situations where it may be 
contraindicated, as outlined in Table 2-2, such as high risk of damaging important 
structures, poor systemic health, or possibility of non-surgical treatment (Chiapasco et 
al., 2018). 

 
 
 
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Table 2-1 Indications for Removal of Impacted Third Molars. 
Indications 
Description 
Infection 
Pericoronitis 
If the first episode is very acute or there has been more than 
one episode. 
Untreatable 
caries, pulpal or 
periapical 
pathology  
The patient is unable to clean the distal aspect of the second 
molar or the area around the wisdom tooth, which is often 
partially erupted. This leads to the accumulation of food 
debris and plaque and then caries of the adjacent tooth 
surfaces. 
Periodontal 
disease 
 
As a result of the unsatisfactory relationship between the 
second and third molars, the area is prone to periodontal 
disease, which may compromise the second molar.  
Cystic change 
 
When third molars are unerupted they may be the source of a 
dentigerous cyst, which can enlarge considerably before 
giving rise to symptoms. 
External or internal resorption 
 
External resorption of the second molar due to pressure from 
the unerupted third molar.  
Internal resorption within the wisdom tooth 
Wisdom 
tooth 
in 
tumour 
resection 
If an impacted wisdom tooth is associated with a tumour at 
the angle of the mandible, or is within the tumour resection 
margins. 
Transplantation 
 
When a patient presents with a heavily restored or carious 
first molar tooth and a partially erupted third molar tooth it is 
possible to transplant the third molar into the socket of the 
first molar. 
Fractured mandible 
 
If a fracture of the mandible through the angle occurs, an 
opportunity may arise to remove the third molar when 
surgical access is being made to treat the fracture itself. 
Atrophic mandible 
 
Third molar in an already atrophic mandible might be a 
potential site for fracture  
Denture or implant design 
 
To facilitate denture design or the accurate placement of 
implants. 
Access to dental care 
 
Where patients are in a situation where they do not have easy 
access to dental care 
Medical condition 
 
Removal of third molars following radiotherapy increases the 
likelihood of the development of osteoradionecrosis. Prior to 
cardiac surgery is another example. 
Orthodontic considerations 
To prevent or reduce imbrication of the incisor teeth. 
Orthognathic 
surgery 
or 
reconstructive surgery 
When orthognathic surgery is being planned, particularly 
with procedures such as sagittal split osteotomy. 

 
 
 
12
 
 
Indications 
Description 
Age of patient 
For young fit patients and not leaving them until an older age 
when the bone is denser and more difficult to manage, and 
when the patient may have medical problems related to older 
age group. 
 
 
Table 2-2 Contraindications to Extraction of Impacted Third Molars. 
Contraindication 
Description 
High risk of damaging 
important anatomic structures 
A CT scan is mandatory to check the relationships between 
the impacted tooth and the involved anatomic structures 
Compromised systemic 
conditions and age of the 
patient 
It can be removed for patients with a partially compromised 
systemic condition under the following notes: 
1. close cooperation with the specialist in charge of the 
patient 
2. perform surgical intervention in a protected 
environment (e.g., hospital),  
3. the possibility to monitor the patient’s vital signs. 
4. assistance from an anaesthetist/intensive care doctor. 
 
In elderly patients, this type of surgery can be more invasive 
due to the higher risk of tooth ankylosis. 
Possibility of surgical 
exposure and orthodontic 
treatment, or 
autotransplantation
In these cases, it’s better to align the impacted teeth by the 
orthodontic treatment or autotransplantation rather than 
removal. 
Poor patient compliance 
When the patient is uncooperative  
 
2.1.4. Techniques for the Removal of Impacted Third Molars 
The typical operative plan for impacted third molar extraction entails five main 
stages: 1) Incision 2) Bone Removal 3) Tooth Sectioning 4) Delivery 5) Wound Closure. 
However, some additional methods are also mentioned, including sagittal split osteotomy, 
buccal corticotomy technique, lingual split bone technique, lateral trepanation technique, 
partial odontectomy/coronectomy, and removal after orthodontic extrusion (Varghese, 
2021) 

 
 
 
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2.1.5. Complications of the Removal of Impacted Third Molars 
Possible complications of third molar removal include nerve numbness 
(paresthesia), dry socket (alveolar osteitis), infections, bleeding, jaw fracture, bone 
infection (osteomyelitis), damage to neighboring teeth, exposed fat pad in the cheek, 
opening between the mouth and sinus cavity (oral-antral communication), displaced teeth, 
inhaled objects (aspiration), gum tissue damage (periodontal defects), and jaw joint 
problems (temporomandibular joint injury). The four most common complications are 
nerve numbness, dry socket, infections, and bleeding (Bouloux et al., 2007). 
While pain, swelling, and trismus are expected following surgery, poor surgical 
technique can exacerbate these issues. Pain management relies on analgesics 
administered before anesthesia wears off. Persistent pain indicates potential infection or 
dry socket requiring follow-up. Transdermal patches have shown effectiveness for post-
extraction pain (Bhargava et al., 2019). Trismus may arise from injury to the medial 
pterygoid muscle or inflammation/hematoma at the extraction site (Fragiskos, 2007). 
Proper patient selection and surgical skill can minimize risks. 
 
2.2. Post-operative Treatment following Third Molar Surgery. 
Following third molar surgery, a course of conventional medication is typically 
prescribed to manage pain, swelling, and infection. Pain management commonly involves 
NSAIDs like ibuprofen or naproxen (Bhargava et al., 2019), while antibiotics may be 
employed to prevent or treat infection (Malamed, 2019). Additionally, corticosteroids 
may be used to combat inflammation and reduce swelling (Undrell Moore, 2011). To 
ensure optimal healing and minimize discomfort, adhering to the prescribed medication 
regimen and following post-operative instructions are crucial (Wayland, 2024). 

 
 
 
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Emerging research suggests potential benefits for both enzymes and 
phytotherapeutic drugs in managing post-surgical pain and swelling. Serratiopeptidase, a 
proteolytic enzyme, has shown promise in reducing inflammation around teeth and 
implants, potentially offering similar benefits after third molar extraction (Sannino et al., 
2013; Villafuerte-Nuñez et al., 2013). Escin, a phytotherapeutic drug derived from horse 
chestnut, exhibits potent anti-inflammatory properties, suggesting its potential in 
reducing post-surgical inflammation and swelling (Wang et al., 2009). Figure 2-6 
summarizes and compares between both medicines as follows: 
 
Figure 2-1 Serratiopeptidase vs. Escin: A Comparative Table. 
 
2.3. Split-mouth Randomized Controlled Trials 
Dental clinical trials offer two options for randomizing treatments: over 
individuals (mouth-level) or over sites within the mouth (site-level). The parallel-group 
design, where the same treatment is applied throughout the entire mouth, is the simplest 
and most commonly used approach. On the other hand, the split-mouth design involves 
random assignment of treatments to specific sites within the mouth. This design utilizes 
each person as their own control, allowing for more precise treatment comparisons 

 
 
 
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(Lesaffre et al., 2009). The split-mouth design was introduced by (Ramfjord et al., 1968) 
to compare the effectiveness of different periodontal therapies within each subject's 
mouth. The design divides the mouth into two halves, randomly assigning different 
treatments to each half. 
The split-mouth design compares treatments within each patient, avoiding bias 
that may arise when comparing separate cases and controls. It eliminates inter-subject 
variability and produces reliable results (Kazancioglu et al., 2014; Lesaffre et al., 2007). 
Compared to between-patient designs, the split-mouth design offers increased efficiency, 
requiring fewer participants and resources while achieving similar results. However, it 
also presents the potential for carry-across effects, where the treatment on one side of the 
mouth influences the response on the other side (Hujoel & Loesche, 1990; Varma & Chiilton, 
1974). To estimate treatment effects in a split-mouth design, researchers make 
assumptions about carry-over effects. Common assumptions include no carry-over effect, 
complete carry-over effect, and partial carry-over effect. These assumptions cannot be 
tested within the study itself and rely on prior knowledge (Hujoel & DeRouen, 1992). 
When choosing a split-mouth design, researchers should consider bias, 
recruitment challenges, efficiency, and statistical analysis. Careful evaluation of potential 
carry-over effects is crucial to avoid bias. Finding suitable patients with symmetrical 
dental conditions can be difficult, and statistical analysis requires more complex methods 
compared to whole-mouth designs (Hujoel, 1998). Controlling carry-over effects in split-
mouth studies is challenging. Washout periods of at least three weeks between treatment 
applications can help mitigate carry-over effects by allowing the body to eliminate 
residual effects of previous treatments (Gozali et al., 2017). Understanding the 
advantages, limitations, statistical considerations, and implications of the split-mouth 
design is essential for researchers in both the statistical and clinical fields. This knowledge 

 
 
 
16
 
 
enables effective utilization of the design while acknowledging its potential drawbacks 
(Lesaffre et al., 2009). 
 

 
 
 
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3. Chapter 3:    
Material and Methods 
 
 

 
 
 
18
 
 
3.1. Study Design 
This clinical trial will utilize a split-mouth design, randomly assigning two 
different treatments to each half of the patient's mouth. From this randomized study which 
is characterized by a triple-blind study, the procedures are going to be performed by 
qualified and experienced professional. However, the operator will have no access to data 
evaluated. The evaluator will have access to all responses of the symptoms of patients 
and will not know the treatment that is going to be selected, while the patient is unaware 
of which treatment or intervention is being applied to each side of their mouth. This 
stringent blinding approach minimizes potential biases and significantly enhances the 
scientific validity of the study. 
Patients will be assigned into two groups and each patient acted as their own 
control using the split-mouth technique. One impacted third molar will be removed from 
one side and will receive conventional drugs while the other side will be removed after 3 
weeks (wash-out period) and receive additional treatment beside the conventional drugs 
(i.e., either enzyme or herbal). The two groups will be classified as follows: 
 The first group will receive conventional drugs with 10mg oral 
serratiopeptidase at immediate post-operative time and three times a day 
for post-operative five days on the first surgical visit and on the second 
surgical visit (after 3 weeks) conventional drugs will be given only or vice 
versa. 
 The second group will receive conventional drugs with 20mg oral escin at 
immediate post-operative time and three times a day for post-operative 
five days on the first surgical visit and on the second surgical visit (after 3 
weeks) conventional drugs will be given only or vice versa. 
 

 
 
 
19
 
 
The conventional drugs, it will be administered to patients in the two groups, 
includes: Amoxicillin 500mg Cap b.i.d., Metronidazole 500mg Tab t.i.d., Diclofenac 
sodium 50mg Tab b.i.d. 
 
3.2. Study Population 
The study population will include patients who will visit the dental clinics in the 
College of Dentistry, University of Science and Technology, Yemen (USTY) for 
impacted mandibular third molars extraction during 2024. 
 
3.3. Sample Size  
The sample size is the number of participants planned to be included in the trial, 
usually determined using a statistical power calculation (Zanatta et al., 2017).  This study 
determined the sample size using a power calculation based on previous research by 
(Costa et al., 2015). Their study found that preemptive use of etoricoxib 120mg 
significantly reduced the need for rescue analgesic medication compared to a placebo (1.6 
± 1.3 vs 4.0 ± 2.5). To achieve a power of 80% and a confidence interval of 95%. The 
study 
will 
need 
to 
evaluate 
11 
surgical 
sites 
per 
sub-group 
(http://www.openepi.com/SampleSize/SSMean.htm). To account for a potential 20% 
drop-out rate, a total of 14 sites per sub-group will be recruited. This will result in a total 
sample size of 56 dental units (2 teeth per patient) from 28 patients. The following Table 
3-1 illustrates the study sample size and the planned treatment. 
 
 

 
 
 
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Table 3-1 : Sample Size and Study Treatment. 
Groups 
I 
II 
Total 
Patients 
14 
14 
28 
Sub-groups 
Control 1 
Study 1 
Control 2 
Study 2 
4 
Sample size 
14 
14 
14 
14 
56 
Conventional 
Treatment 
Amoxicillin 500mg Cap b.i.d 
Metronidazole 500mg Tab t.i.d 
Diclofenac sodium 50mg Tab b.i.d 
N/A 
Study Treatment 
N/A 
Serratiopeptidase 
10mg t.id 
N/A 
Escin 
20mg t.id 
N/A 
 
3.4. Sample Selection 
Patients who will undergo to surgical removal of the impacted third molar will be 
assessed for their eligibility to participate according to the following inclusion and 
exclusion criteria: 
 
Inclusion criteria: 
 
 Medically fit patients. 
 The presence of two asymptomatic mandibular third molar indicated for surgical 
extraction. 
 Absence of pericoronitis or signs of inflammation during the last 30 days 
 
 
 

 
 
 
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Exclusion criteria: 
 
 Patient administered other drugs such as NSAIDS and steroids. 
 Patient has allergy to the drugs used in this study. 
 Pregnant patient or a patient with lactation. 
 Immunocompromised patients with diabetic or hypertension (from patient's 
history). 
 Patients with irradiated maxillofacial region. 
 Intellectually disabled patients and patients unable to come for follow up visits. 
 Patients with acute and subacute pericoronitis 
 
3.5. Randomization  
This clinical trial will utilize simple randomization based on the technique 
described by (Oliveira et al., 2021). This method involves drawing envelopes to 
determine the following: 
 Surgical site: Test or control side 
 Tooth: Right third molar ("A") or left third molar ("B") 
 Surgery order: First or second session 
The following steps of randomization will be followed:  
1. Draw the tooth: An envelope is drawn to determine which third molar will be 
extracted first (right or left). 
2. Draw the intervention: A second envelope is drawn to determine whether the 
selected tooth will receive the test intervention ("X-1") or no intervention ("X-2"). 
3. Draw the surgery order: A final envelope is drawn to determine whether the 
selected tooth will be extracted in the first or second surgery session. 

 
 
 
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3.6. Pre-operative and Post-operative Assessment 
Prior to surgical removal of impacted third molar, preoperative variables (i.e., 
pain, trismus, and facial swelling) will be taken for each patient and recorded in the data 
collection sheet. Furthermore, the same post-operative variables (preoperative variables) 
will be taken immediately after the procedure, 2nd day, 3rd day and 5th day after the 
operation. Both pre-operative and post-operative variables will be done by the same 
measurements. 
 
3.6.1. Assessment of Pain 
Measurements of this outcome will consider pain intensity based on Figure 3-1. 
Preoperative and postoperative pain intensity will be assessed using a standardized 10-
centimeter visual analogue scale (VAS), ranging from 0 (no pain) to 10 (worst possible 
pain) (Sirintawat et al., 2017). Prior to surgery, patients will receive thorough instructions 
on using the VAS to accurately self-report their pain. Following the procedure, they will 
record their pain scores on a standardized form and return it to the researcher on the day 
of suture removal, allowing for continuous monitoring and evaluation of pain 
management effectiveness (Costa et al., 2015). 
 
Figure 3-1 Pain Intensity Measurement. 
 
 

 
 
 
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3.6.2. Assessment of Mouth Opening (Trismus) 
Measurements of this outcome will be via comparing the difference in maximum 
mouth opening ability (MMOA) before and after surgery (Figure 3-2). This will be 
achieved by using a calibrated ruler to measure the distance between the upper and lower 
central incisors in millimeters, both preoperatively (baseline) and at defined post-
operative time points. This approach allows for a quantifiable assessment of trismus 
development and recovery following the intervention (Sreesha et al., 2020). 
 
Figure 3-2 Trismus Measurement - MMOA. 
 
3.6.3. Assessment of Facial Swelling (Edema) 
This outcome will be evaluated through using the method described by (Schultze-
Mosgau et al., 1995) to quantify facial swelling pre- and post-operatively. Measurements 
will be taken with a flexible scale in the closed mouth position by marking five fixed 
points and three surgical base lines connecting the said fixed points as follows:  
 5 fixed points (F1 – tragus of ear, F2 – angle of mandible, F3 – soft tissue 
pogonion, F4 – Corner of mouth, F5 – lateral canthus of eye)  
 3 surgical base lines (S1 – from tragus of ear to corner of mouth, S2 – from 
tragus of ear to soft tissue pogonion, S3 – from lateral canthus of eye to 
angle of mandible). 

 
 
 
24
 
 
 
Figure 3-3 Swelling Measurement. 
3.7. Surgical Procedures 
To minimize variability and bias, all surgical extractions will be performed by the 
same oral surgeon utilizing a uniform technique (Isola et al., 2019). Each patient will 
receive similar operative procedures under identical conditions, including administration 
of local anesthetic consisting of inferior alveolar, lingual, and long buccal nerve blocks. 
Additionally, the same surgical procedure will be adopted for all groups. Access to the 
third molar will be achieved from the buccal aspect. A mucoperiosteal flap will be raised, 
and bone removal with a round bur in a straight handpiece under continuous irrigation 
with a sterile saline solution and/or tooth sectioning will be performed. After tooth 
extraction, the alveolus will be inspected, curetted for granulation tissue removal, and 
irrigated with a sterile saline solution. The surgical wound will be closed using a 4–0 
reabsorbable suture (Coated VICRYL). This meticulous approach minimizes 
intraoperative trauma and ensures consistency across all groups. 
Post-operatively, patients will receive their assigned medications and receive 
thorough instructions regarding dietary restrictions (liquid and cold diet for 24 hours), 
oral hygiene practices, and avoidance of mouthwashes to prevent bleeding. They will be 
informed about potential complications and instructed to contact the surgeon if any issues 
arise. Additionally, they will be requested to report any physical symptoms experienced 
during the study period. 

 
 
 
25
 
 
3.8. Ethical Consideration 
The ethical approval will be obtained from the USTY Medical Research Ethics 
Committee.  The purpose and methodology of the study will be explained to all the 
participants. Hence, a participant information sheet (Appendix B) will be given to all 
participants and a written informed consent form (Appendix C) will be obtained from 
them with the tenets of the revised Declaration of Helsinki 1975. 
 
3.9. Statistical Method 
Quantitative data (pain, trismus, and facial swelling) will be expressed as means 
and standard deviations and compared using the paired t test (parametric) or Wilcoxon 
test (nonparametric). The Shapiro–Wilk test will be used to verify the normality of the 
data. A difference of P < .05 will be considered statistically significant. The data analysis 
will be performed using SPSS V.25 (SPSS, JASP). 
 
 
 

 
 
 
26
 
 
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30
 
 
 
Appendix A: Case Sheet 
 
PERSONAL DETAILS 
Case no. 
 
Name of patient 
 
Age 
 
Sex 
 
Occupation 
 
Contact no. 
 
Address 
 
 
MEDICAL STATUS 
Chief complaint& duration 
 
History of presenting illness 
 
Medical history 
 
Dental history 
 
Oral hygiene 
 
 
IMPACTED THIRD MOLARS DETAILS 
Characteristics 
First visit 
Second visit 
Group: I/II 
 
Sub-group: C/S 
 
 
Side: R/L 
 
 
Depth: A/B/C 
 
 
Angulation: H/M/D/V 
 
 
Position: Class I/Class II/Class III 
 
 
 
SURGICAL DETAILS 
Characteristics 
First visit 
Second visit 
Date of surgery 
 
 
Number of dental cartridges 
 
 
Duration of surgery: min 
 
 
Bone removal: mild/moderate/sever 
 
 
Tooth sectioning: yes/no 
 
 

 
 
 
31
 
 
 
SURGICAL ASSESSMENT – FIRST VISIT 
Pre 
Operative 
 
Immediate 
 
Day
 
nd
2
 
 
3rd Day 
 
5th Day 
 
Mouth 
Opening
Trismus 
 
 
 
 
 
 
Facial 
Swelling
From tragus of ear to corner of mouth 
 
 
 
 
 
 
From tragus of ear to soft tissue 
pogonion 
 
 
 
 
 
 
From lateral canthus of eye to angle of 
mandible 
 
 
 
 
 
 
Pain 
 
 
 
 
 
 
 
 
 
SURGICAL ASSESSMENT – SECOND 
VISIT 
Pre 
Operative 
 
Immediate 
 
Day
 
nd
2
 
 
3rd Day 
 
5th Day 
 
Mouth 
Opening
Trismus 
 
 
 
 
 
 
Facial 
Swelling
From tragus of ear to corner of mouth 
 
 
 
 
 
 
From tragus of ear to soft tissue 
pogonion 
 
 
 
 
 
 
From lateral canthus of eye to angle of 
mandible 
 
 
 
 
 
 
Pain 
 
 
 
 
 
 
 
 
 

 
 
 
32
 
 
Appendix B: Participant Information Sheet 
 
Study Title: 
Comparison of Efficacy of Serratiopeptidase and Escin after Impacted 
Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial 
Principal Investigator: 
Arwa Mohammed Dahak 
College of Dentistry, University of Science and Technology, Sana’a, Yemen 
Telephone: 775163301 
Email: hamddahak@gmail.com 
Ethics Approval Reference: 
University Research Ethics Committee Approval No. 1445/0012/UREC/UST 
Date of Approval: 30/07/2024 
 
1. Introduction 
You are invited to take part in a research study being conducted at the College of 
Dentistry, University of Science and Technology, Sana’a. Before you decide, it is 
important that you understand why the research is being carried out and what your 
participation will involve. Please take time to read this information carefully and ask the 
researcher if anything is unclear. 
 
2. Purpose of the Study 
This study aims to compare the effectiveness of two medications—serratiopeptidase (an 
enzyme-based anti-inflammatory agent) and escin (a natural herbal compound derived 
from horse chestnut)—when used alongside conventional drugs to reduce pain, facial 
swelling (edema), and limited mouth opening (trismus) after the surgical removal of 
impacted mandibular third molars (“wisdom teeth”). 
 
3. Why You Have Been Invited 
You have been selected because you are medically healthy and require the extraction of 
both lower third molars (one on each side). Your participation will help determine which 
medication combination is more effective in improving postoperative recovery. 
 
 
 

 
 
 
33
 
 
4. Study Design and Procedures 
 
This is a triple-blind, split-mouth randomized clinical trial. 
 
Each patient will undergo two surgical procedures, one for each side of the lower 
jaw, separated by a three-week washout period. 
 
During one surgery, you will receive conventional drugs only; during the other, 
you will receive conventional drugs plus either serratiopeptidase or escin. 
 
All surgeries will be performed by the same oral surgeon using standard, safe 
techniques. 
 
You will be assessed before surgery and at several intervals after surgery (2nd, 
3rd, and 5th postoperative days) for: 
o Pain (using a Visual Analogue Scale) 
o Mouth opening (trismus) 
o Facial swelling (edema) 
 
All evaluations are non-invasive and will not cause additional discomfort. 
 
5. Medications Used 
All participants will receive standard postoperative care, including: 
 
Amoxicillin 500 mg twice daily 
 
Metronidazole 500 mg three times daily 
 
Diclofenac sodium 50 mg twice daily 
Depending on your random group: 
 
Group A: Serratiopeptidase 10 mg, three times daily for 5 days 
 
Group B: Escin 20 mg, three times daily for 5 days 
 
6. Possible Benefits 
Participation may help you experience reduced pain, swelling, and trismus after surgery. 
The findings may also benefit future patients undergoing similar procedures by improving 
postoperative management strategies. 
 
7. Possible Risks or Discomforts 
The risks involved are minimal and similar to routine surgical removal of wisdom teeth, 
including: 
 
Pain, swelling, or mild bleeding 
 
Temporary limited mouth opening 
 
Rare allergic reactions to prescribed medications 
All possible adverse reactions will be monitored and managed promptly by the research 
team. 

 
 
 
34
 
 
8. Voluntary Participation and Right to Withdraw 
Participation in this study is entirely voluntary. 
You may choose not to participate or withdraw at any time without giving a reason. This 
will not affect your right to receive standard medical care. You may also refuse to answer 
any questions that make you uncomfortable. 
 
9. Confidentiality 
All information collected during the study will remain strictly confidential. Your name 
will not appear in any publication or report. Data will be coded and stored securely, 
accessible only to the research team. 
 
10. Compensation and Costs 
There are no costs to you for participation, and you will not receive any financial 
compensation. All treatments and medications related to the study will be provided free 
of charge. 
 
11. Ethical Approval 
This study has been reviewed and approved by the University of Science and 
Technology Research Ethics Committee, which ensures that your safety, rights, and 
welfare are protected. 
 
12. Further Information and Contact Details 
If you have any questions or concerns about the study, please contact: 
 
Principal Investigator: Dr. Arwa Mohammed Dahak – Tel: 775163301 
 
Ethics Committee Representative: Dr. Walid Al-Qudsi – Tel: 717163911 
 
13. Statement 
By signing the Informed Consent Form, you confirm that you have read and understood 
this information sheet and agree to participate voluntarily in the study. 
 
 

 
 
 
35
 
 
ورقة معلومات المشارك 
عنوان الدراسة:
 
 مقارنة مدى فعالية السيراتيوبيبتيداز واﻹسكين بعد جراحة الرحى الثالثة السفلية المنطمرة: تجربة سريرية
 تحكمية عشوائية 
الباحثة: أروى محمد حسين دهاق  
 كلية طب اﻷسنان– 
 ﺟامﻌة الﻌلوم والتكنولوﺟيا– 
 ﺻنﻌاء– 
 اليمن 
 :رقم الهاتف775163301
 
البريد اﻹلكتروني :
hamddahak@gmail.com
 
رقم موافقة لجنة اﻷخﻼقيات :
1445/0012/UREC/UST
 
 :تاريخ الموافقة30
  /
07
  /
2024
 
 
1.
 
 المقدمة 
 طب كلية في جرىُت التي البحثية الدراسة هذه في للمشاركة ندعوك اﻷسنان بجامﻌة الﻌلوم والتكنولوﺟيا– 
 .ﺻنﻌاء
 قبل أن تقرر المشاركة، من المهم أن تفهمي/تفهم سبب إﺟراء البحث وما الذي ستتضمنه مشاركتك فيه. الرﺟاء قراءة
هذه المﻌلومات بﻌناية وطرح أي أسئلة على الباحثة إذا كان هناك ما هو غير واضح. 
 
2.
 
 الدراسة هدف 
  تهدف  هذه  الدراسة  إلى
مقارنة  فعالية  دواءين  
  هما
السيراتيوبيبتيداز  )وهو  إنزيم  مضاد  لﻼلتهاب(  و اﻹسكين 
 في التقليدية اﻷدوية مع كمساعدين استخدامهما عند ،(الحصان كستناء نبات من طبيﻌي عشبي مستخلص)
 ،تقليل اﻷلم
 (واﻻنتفاخ الوجهي )الوذمة(، وتحدد الفتح الفموي )التريسمس 
 بﻌد ﺟراحة إزالة الرحى الثالثة السفلية المنطمرة
()ضرس الﻌقل السفلي. 
 
3.
 
 للمشاركة اختيارك سبب 
 مشاركتك .واليسرى اليمنى الجهتين في السفلية الثالثة الرحى خلع إلى وتحتاج اًطبي سليم شخص ﻷنك اختيارك تم
 ستساعد على مﻌرفة أي من الدواءين أكثر فﻌالية في تحسين التﻌافي بﻌد
الجراحة. 
 
4.
 
 وإجراءاتها الدراسة تصميم 

 
 هذه الدراسة
عشوائية، مزدوجة التحكم، وثﻼثية التعمية لضمان الحيادية والدقة الﻌلمية. 

 
 لك جرىُسي
إجراءان جراحيان 
 في فكين مختلفين )اليمين واليسار( بفاﺻل زمني قدره
ثﻼثة أسابيع. 

 
 في إحدى الجراحتين ستحصلين/تحصل على اﻷدوية التقليدية فقط اﻷخرى الجراحة وفي ،
 ستحصلين/تحصل على
اﻷدوية التقليدية باﻹضافة إلى السيراتيوبيبتيداز أو اﻹسكين. 

 والدقة التوحيد لضمان متمرس واحد فم ﺟراح بواسطة الطريقة بنفس الﻌمليات ﺟميع جرىُست. 

 سيتم تقييم حالتك قبل الجراحة وبﻌدها في اﻷيام الثاني والثالث والخامس لقياس: 

 
 
 
36
 
 
o
 اﻷلم )
 باستخدام مقياس بصري من0 
 إلى10
 ( 
o
 
 (مدى فتح الفم )التريسمس 
o
 
 (اﻻنتفاخ الوجهي )الوذمة 

 ﺟميع القياسات غير مؤلمة وﻻ تتطلب أي تدخل إضافي. 
 
5.
 
 المستخدمة اﻷدوية 
 ﺟميع المشاركين سيتلقون نفس الﻌﻼج
التقليدي بﻌد الجراحة، وهو: 

 
 أموكسيسيلين500
 
 ملجم– 
 اًيومي مرتين 

 
 ميترونيدازول500
 
 ملجم– 
 اًيومي مرات ثﻼث 

 
 ديكلوفيناك ﺻوديوم50
 
 ملجم– 
 اًيومي مرتين 
اًعشوائي لها اختيارك يتم التي للمجموعة اًوفق التاليين الدواءين أحد إلى باﻹضافة: 

 
(المجموعة )أ: 
 سيراتيوبيبتيداز10
 أيام خمسة لمدة اًيومي مرات ثﻼث ،ملجم. 

 
(المجموعة )ب: 
 إسكين20
 أيام خمسة لمدة اًيومي مرات ثﻼث ،ملجم. 
 
6.
 
 المحتملة الفوائد 
 في الدراسة هذه نتائج سهمُست كما .الجراحة بﻌد الفموي الفتح وتحدد واﻻنتفاخ اﻷلم تقليل في مشاركتك تساعد قد
تحسين الرعاية المستقبلية للمرضى الذين يخضﻌون ﻹﺟراءات مشابهة. 
 
7.
 المخاطر المحتملة 
المخاطر ضئيلة وتشبه تلك التي ترافق خلع ضرس الﻌقل المﻌتاد، مثل: 

 ألم أو تورم طفيف أو نزيف بسيط 

 
 الفم فتح في مؤقتة ﺻﻌوبة 

 
 اﻷدوية أحد من حساسية لحدوث نادر احتمال 
 ستتم متابﻌة أي أعراض
وﺟدت إن اًفور ومﻌالجتها الباحثة قبل من ﺟانبية. 
 
8.
 الطوعية وحق اﻻنسحاب 
 مشاركتك
اًتمام طوعية.  
 الرعاية تلقي في حقك على ذلك يؤثر أن ودون اﻷسباب ذكر دون وقت أي في الدراسة من اﻻنسحاب لك/ِلك يحق
 الطبية. كما يمكنك اﻻمتناع عن اﻹﺟابة عن أي سؤال ﻻ ترغب في
اﻹﺟابة عليه. 
  
 
  

 
 
 
37
 
 
9.
 سرية المعلومات 
 ﻌاملُست ﺟمﻌها يتم التي المﻌلومات ﺟميع
بسرية تامة. 
 ترميز سيتم .بحثي منشور أو تقرير أي في اسمك ذكرُي لن
البيانات وتخزينها بشكل آمن ولن يطلع عليها سوى فريق البحث. 
 
10
. 
 والتكاليف التعويض 
 مقابل تكاليف أي تحملي/تتحمل لن المشاركة في هذه الدراسة، ولن يتم تقديم أي مقابل مادي. ﺟميع اﻷدوية واﻹﺟراءات
اًمجان قدﱠمُت بالدراسة المتﻌلقة. 
 
11
. الموافقة اﻷخﻼقية 
 تمت مراﺟﻌة هذه الدراسة والموافقة عليها من قبل
لجنة أخﻼقيات البحث العلمي بجامعة العلوم والتكنولوجيا ، والتي
 تضمن حماية
حقوقك وسﻼمتك ورفاهيتك أثناء المشاركة. 
 
12
. لمزيد من المعلومات أو اﻻستفسار 
إذا كان لديك أي أسئلة أو استفسارات حول الدراسة، يمكنك التواﺻل مع: 

 الباحثة الرئيسة:
 
 د. أروى محمد حسين دهاق– 
 :هاتف775163301
 

 عضو لجنة اﻷخﻼقيات:
 
 د. وليد القدسي– 
 :هاتف717163911
 
 
13
. إقرار 
 بتوقيﻌك على
نموذج الموافقة المستنيرة ، فإنك تؤكد أنك قد قرأت هذه الورقة وفهمت محتواها، وأن مشاركتك في
هذه الدراسة تتم بمحض إرادتك الحرة. 
  
 
 

 
 
 
38
 
 
Appendix C: Informed Consent Form 
 
Your signature on this statement means that you have read or listened to the data related 
to this research and that you agree to participate in the research. You will be given a copy 
of this statement to keep . 
Right to Withdraw: 
Your participation in this study is completely voluntary. You have the right to refuse to 
answer any question you do not wish to answer. You have the right to withdraw from the 
study without penalty and without affecting the level of medical care provided to you. 
You will be informed of any new information that emerges during the research period 
that may affect your desire to continue in the study. 
General Conditions: 
The researcher may stop your participation at any time for various reasons. These may be 
related to you personally, such as your condition being incompatible with the study, or 
external, such as the emergence of circumstances or alternatives to the study. 
Confidentiality of the Research : 
All information about you is strictly confidential. You will not be personally referred to 
at the end of the report and presentation of the results. It will not be used for any purpose 
other than scientific research. Only those responsible for conducting the research will 
know about your participation in the research . 
If the participant has any questions, please contact: 
Principal Investigator: Dr. Arwa Mohammed Dahak / Telephone: 775163301 
Member of the College's Scientific Research Ethics Committee, Dr. Walid Al-Qudsi / 
Telephone: 717163911 
Study Participant Consent : 
I, the undersigned, declare that I have read, understood, and agreed to participate in the 
study and have reviewed the details. 
Name: ………………………………………  
 
 
Gender:  
 Male 
 
 Female 
Address: ………………………………………… 
Telephone: ………………… 
Signature: …………..……………    
 
Date: …………………………… 
Researcher's Approval : 
I pledge to maintain the confidentiality of the information of the research subject. 
Researcher's Signature: ……………………  
 
Date: …………… 

 
 
 
39
 
 
 المستنيرة الموافقة نموذج 
 توقيﻌك على هذا البيان يﻌني أنك قد قرأت أو استمﻌت إلى المﻌلومات المتﻌلقة بهذا البحث، وأنك توافق على المشاركة
 .فيه
سيتم تزويدك بنسخة من هذا البيان لﻼحتفاظ بها. 
الحق في اﻻنسحاب:
 
 كما ،عنه اﻹﺟابة في ترغب ﻻ سؤال أي عن اﻹﺟابة رفض في الحق لك .اًتمام طوعية الدراسة هذه في مشاركتك
 المقدﱠمة الطبية الرعاية مستوى على ذلك يؤثر أن ودون ،عقوبة أي دون وقت أي في الدراسة من اﻻنسحاب لك يحق
لك.  
وسيتم إعﻼمك بأي مﻌلومات ﺟديدة قد تظهر خﻼل فترة البحث وقد تؤثر على رغبتك في اﻻستمرار بالمشاركة. 
الشروط العامة:
 
 مع حالتك توافق عدم مثل ،اًشخصي بك متﻌلقة تكون قد ،مختلفة ﻷسباب وقت أي في مشاركتك إيقاف للباحثة يجوز
متطلبات الدراسة، أو ﻷسباب خارﺟية كظهور ظروف أو بدائل أخرى للدراسة. 
سرية البحث:
 
 عند أو التقرير نهاية في شخصك أو اسمك إلى اﻹشارة يتم ولن .تامة بسرية ﻌاملُست بك المتﻌلقة المﻌلومات ﺟميع
فقط الﻌلمي البحث ﻷغراض إﻻ المﻌلومات ستخدمُت لن كما .النتائج عرض.  
وسيﻌلم بمشاركتك في البحث فقط اﻷشخاص المسؤولون عن تنفيذه. 
 
مع التواصل رجىُي ،استفسارات أي وجود حال في:
 

 الباحثة الرئيسية :
 .د أروى محمد دهاق—
 هاتف :
775163301
 

 عضو لجنة أخﻼقيات البحث العلمي بالكلية :
 د. وليد القدسي—
 هاتف :
717163911
 
 
 الدراسة في المشارك موافقة:
 
 أدناه عّالموق أنا ّأقر
تفاﺻيلها ﺟميع على لﻌتّاط وقد ،الدراسة هذه في المشاركة على ووافقت وفهمت قرأت قد بأنني. 
اﻻسم :
......................................................
 
 
 
 
 :الجنس☐
 ذكر  
☐
 
 أنثى  
الﻌنوان :
....................................................
 
 
 
 رقم الهاتف :
........................................
  
التوقيع :
...............................
 
 
 
 
 
 
 
 
 التاريخ :
……….................................
 
 
إقرار الباحثة:
 
 أتﻌهد بالحفاظ على سرية مﻌلومات
المشارك في البحث. 
توقيع الباحثة :
........................................
  
 
 
 
 التاريخ :
........................................