Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Phase: PHASE4
Conditions: Post-operative Pain
Sponsor: Alexandria University

 
 
 
Faculty of Dentistry 
Department of Pediatric Dentistry and Dental Public Health 
 
 
 
Study Protocol and Statistical Analysis Plan 
Masters Degree In Pediatric Dentistry 
Academic Year 2020-2021
 
Dr. Farah Safwat Nemr 
 
Title: EFFECTIVENESS OF PRE-EMPTIVE ANALGESICS ON POST-
OPERATIVE PAIN AFTER STAINLESS STEEL CROWN PLACEMENT ON 
PRIMARY MOLARS: RANDOMISED CONTROLLED CLINICAL TRIAL 
 
 
NCT Number: Not yet assigned
 
Document Date: 19-10-2022 
 
 
 
Keywords: Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, 
stainless steel crown, primary molars 
 
 
Supervision Committee: 
1. Prof. Dr. Karin ML Dowidar 
    Professor of Pediatric Dentistry. 
    Department of Pediatric Dentistry and Dental Public Health. 
 Faculty of Dentistry, Alexandria University.  
 
2. Dr. Reham Soliman  
    Lecturer of Pediatric Dentistry.    
Department of Pediatric Dentistry and Dental Public Health.  
 Faculty of Dentistry, Alexandria University. 

OUTLINE  
Content          
 
 
 
 
 
 
 
      Page  
 
− ABSTRACT 
1 
 
− INTRODUCTION  
2 
 
− AIM OF THE STUDY 
5 
− RESEARCH DESIGN 
6  
− PLAN OF THE STUDY 
7 
− STATISTICAL ANALYSIS 
19 
− ETHICAL CONSIDERATIONS 
20 
− PROBLEMS ANTICIPATED 
21 
− DURATION OF STUDY 
22 
− ESTIMATED BUDGET 
23 
 
− ROLE OF SUPERVISORS 
24 
− APPENDICES 
27 
− REFERENCES 
28

 
 
1
 
 ABSTRACT 
 
Background: Pre-emptive analgesia is a concept which aims to minimize post-operative pain 
and discomfort following painful dental procedures, thus, ensuring a comfortable dental 
experience. 
 
Objective: The aim of this study is to evaluate the effectiveness of pre-emptive analgesia using 
ibuprofen and paracetamol on reducing post-operative pain following the placement of stainless 
steel crowns on primary molars compared to placebo. 
 
Method: The study will be a parallel, placebo-controlled, triple-blinded, randomized clinical 
trial. A total of 66 healthy children aged 5-8 years requiring the placement of a stainless steel 
crown will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of 
Dentistry, Alexandria University, Egypt. The children will be randomly allocated into three 
groups according to the type of pre-emptive solution used. Group I will receive ibuprofen, group 
II will receive paracetamol, while group III (control) will receive a placebo solution.  Children 
will self-report their level of pain using a Visual analogue scale (VAS) and/or a Facial pain scale 
(FPS) after local anesthesia administration, immediately after the cementation of the stainless 
steel crown, and 2, 6 and 24 hours post-operatively. Children’s baseline anxiety and parental 
anxiety will also be assessed. 
 
Results: Data will be collected, tabulated and statistically analyzed to obtain the results and 
conclusions of this study. 
 
Keywords: Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, stainless steel 
crown, primary molars 
 

 
 
2
INTRODUCTION 
      Successful pediatric dental treatment depends on several factors, including the alleviation of 
fear and anxiety, efficient pain control and the establishment of a trusting relationship with the 
pediatric patient.(1,2) Painful, traumatic or negative dental experiences, especially in childhood 
could have long lasting negative effects, such as avoidance of regular dental checkups, increased 
dental problems and symptomatic treatment needs.(3–6) 
      Pain is a highly individualized experience.(7) Even though pain control can be effectively 
achieved with the use of local anaesthetics and the majority of children receive dental care without 
experiencing postoperative discomfort, it has been reported that about a third of children 
undergoing routine dental treatments under local anesthesia still experience postoperative 
pain.(8,9) 
      Pre-emptive analgesia is a concept that aims to minimize post-operative pain and discomfort 
by preventing peripheral and central sensitization, thus diminishing or ideally preventing the post-
operative amplification of pain sensation, improving recovery and reducing postoperative 
analgesic consumption.(10,11) The concept was first introduced by Crile(12), and is known as the 
“anoci-association” theory. Crile studied the effect of administration of multiple anesthetic agents 
and techniques, before, during and after surgery and postulated that postoperative morbidity could 
be decreased by blocking the transmission of pain prior to the surgical incision. 
      The concept of pre-emptive analgesia has been employed in several studies conducted on adult 
patients. In patients undergoing third molar extraction under local anesthesia, the use of pre-
emptive analgesics resulted in a marked decrease in post-operative pain scores.(13–15) 
Additionally, studies conducted on patients undergoing endodontic procedures have also reported 
a decrease in postoperative pain when pre-emptive analgesics were used.(16,17) The concept has 
also been investigated in patients undergoing implant surgeries and a recent study reported that the 
use of ibuprofen as a pre-emptive analgesic 1 hour before the procedure, resulted in a reduction in 
post-operative pain and less need for a rescue analgesic as compared to placebo, thus supporting 
the use of pre-emptive analgesics.(18) 

 
 
3
      Ibuprofen, paracetamol, diclofenac and tramadol have been used in pediatric dentistry for pain 
management, however, paracetamol and ibuprofen are the most commonly prescribed analgesics 
for treatment of acute pain.(19,20) Paracetamol is an analgesic that acts peripherally; although its 
primary site of action is still debatable, it is thought to inhibit prostaglandins in the 
hypothalamus.(21) Effective dosages are between 15–20mg/kg/day to a maximum of 60 
mg/kg/day and its peak of action is achieved within 1-2 hours of administration.(22) Ibuprofen is 
a non-steroidal anti-inflammatory drug which acts by reducing the production of cyclo-oxygenases 
(COX-1 and COX-2)- derived prostanoids in the blood. (23)It is effective in dosages ranging from 
10 mg/kg/day to a maximum of 40 mg/kg/day, and it reaches its peak concentration in the plasma 
between 15-30 minutes following administration.(22) Both drugs are safe, but some reports show 
that ibuprofen is slightly more effective due to its anti-inflammatory action.(24) 
      Ibuprofen and paracetamol have been used in several studies to investigate their effect as pre-
emptive analgesics on reducing post-operative pain following the extraction of primary molars, 
however, the results were contradictory.(22,25,26) One study revealed that the use of pre-emptive 
analgesics showed lower post-operative pain scores compared to the placebo following the 
extraction of primary molars, while another study concluded that pre-emptive administration of 
analgesics did not significantly reduce trans- and post-operative pain in children after primary 
molars extraction. In a study investigating the effectiveness of pre-treatment with ibuprofen on 
post-operative pain following pulpotomy of primary molars,  children who received ibuprofen as 
a premedication, experienced less pain following the pulpotomy and stainless steel crown 
placement in comparison to children who received placebo, however, it cannot be determined 
whether the post-operative pain experienced in the placebo group was due to the pulpotomy 
procedure or the placement of the stainless steel crown.(20) 
      A recent systematic review stated that there was not enough evidence to determine whether 
pre-emptive analgesia is beneficial in the reduction of post-operative pain in the pediatric 
population or not, due to the low methodological quality of the available studies.(27) 
       
 

 
 
4
      The placement of a stainless steel crown is a common dental procedure that is performed on 
daily basis and is not limited to teeth undergoing endodontic treatment. According to an 
observational study that was conducted to measure the incidence of pain and analgesic use 
following restorative and surgical procedures in children and adolescents, patients who had 
received a primary stainless steel crown were significantly more likely to report postoperative 
discomfort as compared to those who had undergone other routine procedures including primary 
teeth extraction, and the majority were given over-the-counter analgesics.(28–30) Therefore, 
seeking methods to decrease pain and discomfort following the placement of stainless steel crowns 
is of utmost importance to ensure a comfortable dental experience. 
      Most studies in the literature have investigated the effect of pre-emptive analgesia on post-
operative pain in children who have undergone primary molar extractions; only a few have 
evaluated the effect of pre-emptive analgesia on post-operative pain following the placement of 
stainless steel crowns. Therefore, this study attempts to evaluate the effectiveness of pre-emptive 
analgesic drugs in reducing post-operative pain following the placement of a stainless steel crown 
on non-pulpotomized maxillary primary molars compared to placebo, taking into consideration 
confounding factors, such as age, child’s dental anxiety, parental dental anxiety and the child’s 
behavior during the dental treatment. 
      The null hypothesis is that there will be no significant difference in the level of post-operative 
pain experienced after the placement of stainless steel crowns with the pre-emptive administration 
of ibuprofen and paracetamol analgesics compared to placebo. 
 
 
 
 
 
 
 
 
 

 
 
5
AIM OF THE STUDY 
 
Primary Aim: 
• To evaluate and compare the effectiveness of premedication with ibuprofen and 
paracetamol on reducing post-operative pain following the placement of stainless steel 
crowns on primary molars compared to placebo  
 
Secondary Aims: 
• To evaluate and compare the effectiveness of premedication with ibuprofen and 
paracetamol on reducing trans-operative pain during local anesthesia administration 
• To evaluate the effect of dental anxiety on children’s perception of pain 
• To evaluate the effect of parental anxiety on their children’s anxiety and behavior during 
dental procedures 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

 
 
6
RESEARCH DESIGN 
 
Randomised Controlled 
Clinical Trial 
Participants assessed for 
eligibility   
Allocation 
Random allocation 
• 
Excluded participants: 
• 
Not meeting inclusion criteria  
Group I 
Allocated to 
Ibuprofen (n=22) 
 
Group II 
Allocated to 
Paracetamol (n=22) 
 
Group III(Control) 
Allocated to Placebo 
(n=22) 
Intervention 
Group I 
Ibuprofen (n=22) 
 
Group II 
Paracetamol (n=22) 
 
Group III(Control) 
Placebo (n=22) 
Follow-Up 
After 2, 6 and 24 hours 
Lost to follow up 
Statistical analysis  
Analysis 
Figure (1): Flow Chart Study Design 

 
 
7
PLAN OF THE STUDY 
Study Design  
      This study will be a three arm, parallel group, triple blinded, placebo-controlled, randomized 
clinical trial. It will be set up and reported according to the CONSORT statement.(31)   
       The PICO question will be: Do pediatric patients aged 5-8 (P: population) receiving pre-emptive 
analgesics; ibuprofen and paracetamol (I: intervention) in comparison to placebo (C: control), experience less 
post-operative pain following the placement of stainless steel crowns (O: outcome)?  
 
Study setting and location 
       Participants will be recruited from the outpatient clinic, Pediatric Dentistry and Dental Public 
Health Department, Faculty of Dentistry, Alexandria University, Egypt. 
 
Sample size estimation 
   Sample size was estimated assuming 5% alpha error and 80% study power. Viswanath et al.(32) 
reported mean ± SD pain score after 24 hours of using ibuprofen = 18.84 ± 14.32, and 36.5 ± 25.05 
when acetaminophen (paracetamol) was used. Pre-emptive analgesics are assumed to have a 
similar effect in decreasing post-operative pain in children. (22) Based on comparison of means, 
sample size was calculated to be 20 per group, increased to 22 for procedural problems. The total 
required sample size= number of groups × number per group= 3 x 22 = 66.(33) 
 
Eligibility Criteria: 
Participant inclusion criteria: 
• Age range 5 to 8 years old 
• Children without any previous interventional dental experience 
• Children free of any systemic disease or special health care needs (ASA 1)(34) 
• Children free of any allergies or hypersensitivity reactions to local anesthetics or analgesic 
drugs 
• Positive or definitely positive behaviour during preoperative assessments according to the 
Frankl Rating Scale (score 3 or 4) (Appendix I)(35) 
• Parents/caregivers and children who are willing to participate in the study 

 
 
8
Tooth inclusion criteria:  
• Maxillary first or second primary molar teeth with extensive and/or multisurface caries 
where other restorations are likely to fail but without pulp exposure (29,30,36)  
• Absence of clinical and radiographic signs or symptoms  of irreversible pulpitis(37) 
• Absence of fistula or abscess near the selected tooth clinically and radiographically(38) 
• Absence of spontaneous pain(38) 
• Absence of pulp exposure 
• Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal 
fossa, and gently rocking the tooth bucco-lingually(39) 
 
Materials 
• Periapical radiographs 
• Ibuprofen 100 mg/5 ml* 
• Paracetamol 250 mg/5 ml** 
• Topical Anaesthesia – Benzocaine gel 20%. *** 
• Short 30-gauge anaesthetic needles.  
• Local anaesthetic carpules: Articaine hydrochloride 4% with adrenaline 1:100,000. **** 
• Dental anaesthetic syringe (non-disposable breech loading, metallic cartridge type) 
• Diagnostic sets 
• Excavators 
• Stainless steel crowns***** 
• Glass ionomer cement ****** 
1 
 
 
 
1
Pharmaceuticals & Chemical Industries Co.
, Kahira 
®
BRUFEN
 
*  
, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
®
CETAL
 
**
 
***Dharma Research, Inc. 5220 NW 72nd Ave Miami, FL 33166 USA..
 
**** ARTINIBSA, Inibsa Dental S.L.U, 08185 Lliçà de Vall, Barcelona, Spain
 
N, USA
l Crowns, 3 M™ ESPE™, St.Paul, M
Stainless Stee
 
*****
 
******Fuji IX capsules (GC Fuji IX GP,GC America)
 

 
 
9
Randomization   
      Participants complying with the inclusion criteria will be randomly assigned using a computer 
generated list of random numbers (40) to one of the three arms (Ibuprofen, paracetamol and 
placebo).  
Allocation will be performed by a trial independent individual using permuted block technique, 
where the allocation ratio is intended to be equal to ensure that the study groups have equal number 
of children. 
 
 Allocation Concealment 
      The list of allocation will be generated prospectively using random allocation software where 
participants are allocated in blocks of six. Each child included in the study will be given a serial 
number that will be used in the allocation. These numbers will be written on identical sheets of 
paper with the group to which each child will be allocated. The papers will be placed in opaque 
envelopes carrying the respective sequence of the children.(41) A trial independent personnel will 
be assigned the role of keeping the envelopes and unfolding them only at the time of pre-emptive 
solution administration. 
 
Grouping  
The participants will be randomly divided into 3 groups according to the pre-emptive solution received:  
Group I: (Study group I) will receive ibuprofen  (N=22). 
Group II: (Study group II) will receive paracetamol (N=22).                    
Group III: (Control) will receive placebo  (N=22). 
 
Blinding 
      The participant, operator and statistician will be blinded to the pre-emptive solution group. 
After data collection is completed, the randomization code will be broken to reveal the allocation 
group.  
 
 
 

 
 
10
Intra examiner reliability 
   A theoretical training will be carried out by a gold standard researcher with the operator, 
assistant, and evaluator before the data collection, where all steps of the procedures will be 
discussed, and all the scales and questionnaires used in the research will be presented.  
   Thereafter, a pediatric dentistry specialist will calibrate the operator for the use of the Venham’s 
behavior rating scale (VBRS) through the observation of videos of children undergoing dental 
procedures and the classification of the child’s behavior after watching each video. After a 7-day 
interval, the exercise will be repeated, and the intra-examiner Kappa concordance coefficient will 
be calculated and score above 0.8 will be accepted (kappa >0.8). 
     
Method 
Preliminary screening visit 
      To ensure fulfillment of the inclusion criteria, a complete medical and dental history will be 
taken from the selected patients’ parents/caregivers and only patients whose parents/caregivers 
will agree to give their consent to participate will be examined. Thorough clinical examination and 
an intraoral periapical radiograph of the tooth to be restored will be obtained for definitive 
diagnosis. Children fulfilling the selection criteria, whose parents/ caregivers consented 
participation will be scheduled for more visits. 
Patient Preparation Visit(42) 
      This will be an introductory visit without any clinical intervention to acquaint the child with 
the dental atmosphere and help establish a good relationship between the child, and the dentist and 
the dental staff. ‘Tell-Show-Do’ technique will be used to introduce the dental instruments and 
materials to the child. Topical fluoride will be applied to the children’s teeth and oral hygiene 
instructions will be given to both, the children and their parents. 
 
 
 

 
 
11
Intervention Visit 
Preparation of the pre-emptive solutions: 
      Both pre-emptive analgesics will be fruit-flavored, and the placebo solution will be freshly 
prepared by an assistant in a manner to match the color and odor of the analgesics. To ensure 
blinding, the three pre-emptive solutions will be placed in similar single-dose glass bottles. The 
bottles will be encoded and only the assistant who prepared the solutions will be aware of the 
content of each bottle. 
Administration of the pre-emptive solution: 
   Children will be randomly assigned to one of three pre-emptive solutions:  
• Group I: ibuprofen 100 mg/5 ml (BRUFEN®, Kahira Pharmaceuticals & Chemical 
Industries Co.)  
• Group II: paracetamol 250 mg/5 ml (CETAL®, EGYPTIAN INT. PHARMACEUTICAL 
INDUSTRIES CO.) 
• Group III: placebo solution (Control) 
      The assistant will weigh each child in the waiting area using a calibrated balance and each 
child will receive a weight-dosed volume of the assigned solution to maintain operator and 
evaluator blinding. The assistant will watch each child to make sure they drink the entire solution.  
      For standardization of the waiting period (ensuring participants’ blinding) and for the drugs to 
reach their peak of action, the solutions will be administered 1 hour prior to the local anesthesia 
administration.(22) The time of the pre-emptive solution administration will be recorded on the 
data sheet.  
 
 
 

 
 
12
Clinical Procedure 
      For standardization, all clinical procedures will be performed by a single trained and calibrated 
operator after undergoing a training period according to the criteria adopted. 
 
Local Anesthesia administration:(43) 
• Prior to the administration of local anesthesia, topical anesthetic gel will be applied for 1 
minute to the area of injection after drying it with a piece of gauze to minimize the painful 
sensation of needle penetration into the soft tissues. 
• The children will then receive buccal infiltrative anesthesia with Articaine to eliminate 
the need for a palatal injection. (44–46) 
• Achievement of the anesthetic effect will be assessed by probing the soft tissues adjacent 
to the anesthetized tooth.  
• After five minutes, when the anesthetic effect is observed, the operator will start 
removing the caries and preparing the tooth. 
Caries removal and stainless steel crown preparation:(36) 
   
• Using a high-speed handpiece and an excavator, all caries will be removed.  
• The proximal surfaces of the teeth will then be reduced using Number 69L bur at high 
speed, taking care not to damage adjacent tooth surfaces.  
• Slight separation between the teeth for better access could be achieved by tightly placing 
a wooden wedge between the surface being reduced and the adjacent surface.  
• Near vertical reductions will be made on the proximal surfaces and carried gingivally 
until the contact with the adjacent tooth is broken.  
• Using the same bur, the cusps and the occlusal portion of the tooth will be reduced, 
following the general contour of the occlusal surface until a clearance of approximately 
1mm with the opposing teeth is achieved. 
• All sharp line and point angles will be removed.  
 
 
 

 
 
13
Stainless steel crown selection and cementation:(36) 
• The smallest crown size that completely covers the preparation will be chosen, ensuring 
the establishment of the correct occlusogingival crown length.  
• The crown should be shaped circumferentially to follow that natural contours of the 
tooth's marginal gingivae.  
• If the crown is loosely fitting; Crown contouring pliers with a ball and socket design 
will be used at the cervical third of the buccal and lingual surfaces to help adapt the 
margins of the crown to the cervical portion of the tooth.  
• After contouring the crown, the crown will be tried again to make sure it fits the 
preparation snugly and extends under the free margin of the gingival tissue.  
• The crown will then be removed, cleaned and dried, and the tooth will be partially 
isolated using cotton rolls and a saliva ejector.  
• The crown will be generously loaded with GIC (at least two thirds full) avoiding air 
bubbles and voids and will be placed over the tooth and seated into place by finger 
pressure or by asking the child to bite it into place.  
• Excess GIC will be wiped away with a cotton wool roll or the gauze swab used to protect 
the airway.  
• Removal of excess cement between the contacts will be achieved by flossing the 
contacts. 
 
Post-operative instructions: 
• Children will be instructed to avoid scratching, or injuring the lips, or the gingiva if 
numbness is felt 
• Parents of children in the 3 groups will be given an elixir of either ibuprofen or paracetamol 
and will be instructed to use it only if necessary 
• If the rescue medication is needed, the parents will be instructed to give the children only 
one dose every 6 hours and record the number of times the analgesic was used  
 
Follow-up 
     Patients will be followed up via telephone at 2, 6 and 24 hours post-operatively 

 
 
14
Study Outcomes 
Primary outcome: 
Post-operative pain evaluation: (0,2,6,24 hours post-operatively) 
• The primary outcome to be evaluated is the post-operative pain experienced following the 
placement of a stainless steel crown.  
• Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 
mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a 
facial pain scale (FPS) (Fig.2).(47,48)  
• Children will self-report their level of pain four times post-operatively; the first time will 
be immediately following the cementation of the stainless steel crown where the operator 
will explain the scales to the parent and the child, and the child will be asked to choose the 
face or score which best describes the level of pain that he/she feels.  
• A copy of the VAS and FPS will then be given to the parents and they will be instructed to 
show it to their children at home to assess the level of pain at 2, 6 and 24 hours post-
operatively and will report the score to the operator via telephone.  
 
 
 
Figure (2) Visual Analogue Scale 
(VAS)and Facial Pain Scale (FPS)  
VAS 
FPS 

 
 
15
 Secondary outcomes: 
 
1. Trans-operative pain evaluation: 
To assess the effectiveness of pre-emptive analgesics in reducing pain during local 
anesthesia administration, after local anesthesia administration, the child will be shown the 
VAS and FPS (Fig. 2) and he/she will be asked to choose the score or face which best 
describes the level he/she felt during administration of the anesthetic solution.  
 
 
Figure (2) Visual Analogue Scale 
(VAS)and Facial Pain Scale (FPS)  

 
 
16
 
2. Evaluation of the child’s dental anxiety: 
To assess the child’s anxiety, the Arabic version of the faces version of Modified Child 
Dental Anxiety Scale (MCDASf) (Fig.3) will be used. The MCDAS consists of eight 
questions to assess dental anxiety about specific dental procedures. A five-point Likert 
scale is used to determine dental anxiety with scores ranging from ‘relaxed/not worried’ to 
‘very worried’.(49) The faces version of Modified Child Dental Anxiety Scale (MCDASf) 
has a faces analogue scale anchored above the original numeric form.(50) In the Arabic 
version of the MCDASf, the last question about conscious sedation was removed as per the 
experts’ opinions because the children are unfamiliar with this practice.(51) In the waiting 
room, prior to the administration of the pre-emptive solution, the evaluator will explain the 
questions and the 5 faces to the child and the child will be asked to point to the face which 
best describes how he/she feels about the dental procedure explained. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
17
 
 
 
 
 
 
 
 
 
 
 
 
How do you feel 
about … 
Relaxed/not 
worried 
 
Very 
slightly 
worried 
 
Fairly 
worried 
 
 
Worried 
a lot 
 
 
Very 
worried 
 
 
..going to the dentist 
generally? 
1 
2 
3 
4 
5 
..having your teeth 
looked at? 
1 
2 
3 
4 
5 
..having your teeth 
scaled and polished? 
1 
2 
3 
4 
5 
..having an injection 
in the gum? 
1 
2 
3 
4 
5 
..having a filling? 
1 
2 
3 
4 
5 
..having a tooth 
taken out? 
1 
2 
3 
4 
5 
..being put to sleep 
to have treatment? 
1 
2 
3 
4 
5 
..having a mixture of 
‘gas and air’ which 
will help you feel 
comfortable for 
treatment but cannot 
put you to sleep? 
 
1 
 
2 
 
3 
 
4 
 
5 
Figure (3) Faces version of Modified 
Child Dental Anxiety Scale 
(MCDASf) 

 
 
18
3. Evaluation of parental anxiety: 
Parental anxiety will be evaluated using the Arabic version of the Modified Dental Anxiety 
Scale (MDAS)(Fig. 4).(52) The questionnaire will be answered by parents in the waiting 
room before the intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
19
Can you tell us how anxious you get, if at all, with your dental visit? 
Please indicate by inserting ‘X’ in the appropriate box 
 
1. If you went to your Dentist for TREATMENT TOMORROW, how would you feel? 
 
Not  
Anxious    
Slightly  
Anxious   
Fairly  
Anxious   
Very  
Anxious   
Extremely  
Anxious   
 
2. If you were sitting in the WAITING ROOM (waiting for treatment), how would you feel? 
 
Not  
Anxious   
Slightly  
Anxious   
Fairly  
Anxious   
Very  
Anxious   
Extremely  
Anxious   
 
3. If you were about to have a TOOTH DRILLED, how would you feel? 
 
Not  
Anxious   
Slightly  
Anxious   
Fairly  
Anxious   
Very  
Anxious   
Extremely  
Anxious   
 
4. If you were about to have your TEETH SCALED AND POLISHED, how would you feel? 
 
 
Not  
Anxious   
Slightly  
Anxious   
Fairly  
Anxious   
Very  
Anxious   
Extremely  
Anxious   
 
5. If you were about to have a LOCAL ANAESTHETIC INJECTION in your gum, above an 
upper back tooth, how would you feel? 
 
 
Not  
Anxious   
Slightly  
Anxious   
Fairly  
Anxious   
Very  
Anxious   
Extremely  
Anxious   
 
Instructions for scoring (remove this section below before copying for use with patients) 
The Modified Dental Anxiety Scale.  Each item scored as follows: 
Not anxious 
 
= 
1 
Slightly anxious 
= 
2 
Fairly anxious  
= 
3 
Very anxious  
= 
4 
Extremely anxious 
= 
5 
 
Total score is a sum of all five items, range 5 to 25:  Cut off  is 19 or above which indicates a 
highly dentally anxious patient, possibly dentally phobic  
 
Figure (4) Modified Dental 
Anxiety Scale (MDAS) 

 
 
20
 
4. Evaluation of the child’s overall behavior during the dental treatment: 
 
Venham’s Behavior rating scale (VBRS) (Fig. 5) will be used to evaluate the overall 
child’s behavior during dental treatment. VBRS classifies the child’s behavior into 6 
categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a 
score of 5 refers to complete absence of compliance and cooperation and the requirement 
of physical restraint.(53) At the end of the dental visit, the operator will assign a score to 
each child based on the child’s overall behavior during the dental visit. 
 
 
 
 
Score 
Behavior 
0 
Total cooperation, best possible working conditions, no 
crying or physical protest 
1 
Mild, soft verbal protest, or (quiet) crying as a signal of 
discomfort, but does not obstruct progress. 
Appropriate behavior for procedure, that is, slight start 
at injection, ‘ow’ during drilling if hurting, etc 
2 
Protest more prominent. Both crying and hand signals. 
May move head around making it hard to administer 
treatment. Protest more distracting and troublesome. 
However, child still complies with request to cooperate 
3 
Protest presents real problem to dentist. Complies with 
demands reluctantly, requiring extra effort by dentist, 
body movement 
4 
Protest disrupts procedure, requires that all of the 
dentist’s attention be directed toward the child’s 
behavior. 
Compliance eventually achieved after considerable 
effort by dentist, but without much actual physical 
restraint. (May require holding child’s hands or the like 
to start). More prominent body movement 
5 
General protest, no compliance, or cooperation. 
Physical restraint is required 
Figure (5) Venham’s Behavior 
Rating Scale (VBRS) 

 
 
21
 
STATISTICAL ANALYSIS 
The results will be collected, tabulated, and statistically analyzed to fulfill the aim. Intention-to-
treat analysis concept will be adopted throughout the analysis. Descriptive quantitative data will 
be analyzed using mean and standard deviation, while count and percent will be used for qualitative 
data. Comparison between normally distributed data will occur using Independent samples t- and 
Paired t-tests. For non-normally distributed data, Mann-Whitney U and Wilcoxon signed-rank tests 
will be used. 

 
 
22
ETHICAL CONSIDERATIONS 
      The study will be conducted following the ethical principles for medical research involving 
human subjects in Declaration of Helsinki.(54) Ethical approval will be obtained from the 
Research Ethics Committee, Faculty of Dentistry, Alexandria University before starting the study.  
      The objectives, risks and benefits of the study will be explained to parents/ guardians and a 
signed informed consent will be obtained prior to treatment. (Appendix II). Verbal consent will be 
obtained from the children before the intervention. Data confidentiality will be ensured as well as 
interim analysis if needed. 
      Parents and children will be given age-appropriate dental health with proper oral hygiene 
instructions including proper teeth brushing twice a day especially before bedtime, as well as 
flossing if indicated. These measures will be demonstrated on a model. A fluoridated toothpaste 
and a brush will be provided to each participant on the day of the treatment. 
     All needed treatment will be provided to the child including any restorations, space maintainers 
and fluoride application. All the possible clinical and/or adverse outcomes will be explained to the 
parents and they will be asked to report immediately if any adverse outcome occurs. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
23
PROBLEMS ANTICIPATED 
1. Difficulty in finding patients who fulfill the inclusion criteria of the study 
2. Lack of compliance from patients and/or their parents. 
 
 
 
 
 

 
 
24
DURATION OF THE STUDY 
Estimated time: 13 Months. 
 
 
 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
Proposal writing  
✓ 
✓ 
 
 
 
 
 
 
 
 
 
 
 
Sample selection  
 
 
✓ 
✓ 
 
 
 
 
 
 
 
 
 
Dental procedure 
 
 
 
 
✓ 
✓ 
✓ 
✓ 
 
 
 
 
 
Data management 
and statistical 
analysis 
 
 
 
 
 
 
 
 
✓ 
 
 
 
✓ 
 
 
 
 
 
 
Writing thesis 
 
 
 
 
 
 
 
 
 
 
 
✓ 
 
✓ 
 
 
Thesis submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
✓ 
Months 
Tasks 

 
 
25
ESTIMATED BUDGET  
Estimated total budget 22,000 LE 
 
Total 
price (LE)
Materials
 
No
 
12,000
 
Materials 
 
1
 
2,000
 
Statistical analysis
 
2
 
2,000
 
Computer services
 
3
 
2,000
 
Printing services
 
4
 
3,000
 
Publication cost
 
5
 
1.000
 
Others
 
6
 
22,000
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
26
ROLE OF SUPERVISORS 
 
1. Prof. Karin ML Dowidar 
            Helping the student in interpreting the results and revising the thesis. 
2. Dr. Reham Soliman 
Supervision of the blinding and the clinical work 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
27
 
APPENDICES 
APPENDIX I 
                                       Frankl Behaviour Rating Scale 
 
 
 
 
 
 
Rating 
Behaviour 
Mild  
discomfort 
1 
Definitely  
Negative 
Refusing to play game, crying forcefully 
or fearfully, or any other overt evidence of 
extreme negativism 
2 
Negative 
Reluctance to playing, uncooperative 
behaviour, and some evidence of negative 
attitude that is not pronounced 
3 
Positive 
Acceptance of playing, willingness to 
comply with the dentist, cooperative 
behaviour 
 
4 
Definitely  
Positive 
Good rapport with the dentist, interested in 
the environment, laughing, and enjoying 
the situation 

 
 
28
REFERENCES 
 
1.  
Goettems M, Zborowski EJ, Costa F, Costa VPP, Torriani DD. Nonpharmacologic 
intervention on the prevention of pain and anxiety during pediatric dental care: a 
systematic review. Acad Pediatr. 2017;17(2):110–9.  
2.  
American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental 
patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill. Am Acad Pediatr 
Dent. 2020;292–310.  
3.  
Milgrom P, Mancl L, King B, Weinstein P. Origins of childhood dental fear. Behav Res 
Ther. 1995;33(3):313–319.  
4.  
DS QT. Dental anxiety and regularity of dental attendance in younger adults. J Oral 
Rehabil. 29(6):604–608.  
5.  
Armfield JM, Stewart JF, Spencer AJ. The vicious cycle of dental fear: Exploring the 
interplay between oral health, service utilization and dental fear. BMC Oral Health. 14(7).  
6.  
Oliveira MA, Bendo CB, Ferreira MC, Paiva SM, Vale MP, Serra-Negra JM. Association 
between childhood dental experiences and dental fear among dental, psychology and 
mathematics undergraduates in Brazil. Int J Environ Res Public Health. 2012 Dec 
17;9(12):4676–87.  
7.  
Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, et al. The revised 
International Association for the Study of Pain definition of pain: concepts, challenges, 
and compromises. Pain. 2020;161(9).  
8.  
Mittal M, Sharma S, Kumar A, Chopra R, Srivastava D. Comparison of anesthetic 
efficacy of articaine and lidocaine during primary maxillary molar extractions in children. 
Pediatr Dent. 2015;37(7):520–4.  
9.  
Ashkenazi M, Blumer S, Eli I. Post-operative pain and use of analgesic agents in children 
following intrasulcular anaesthesia and various operative procedures. Br Dent J. 
202(5):276–7.  
10.  
Costa FWG, Esses DFS, de Barros Silva PG, Carvalho FSR, Sá CDL, Albuquerque AFM, 
et al. Does the Preemptive Use of Oral Nonsteroidal Anti-inflammatory Drugs Reduce 
Postoperative Pain in Surgical Removal of Third Molars? A Meta-analysis of Randomized 
Clinical Trials. Anesth Prog. 2015;62(2):57–63.  

 
 
29
11.  
American Academy of Pediatric Dentistry. Pain management in infants, children, 
adolescents, and individuals with special health care Needs.The Reference Manual of 
Pediatric Dentistry. Chicago, Ill. Am Acad Pediatr Dent. 2020;362–70.  
12.  
Crile GW. The Kinetic Theory of Shock and its Prevention Through Anoci-association. 
Lancet. 1913;182(4688):7–16.  
13.  
Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive 
analgesic effect of tramadol after mandibular third molar extraction: a  pilot study. J oral 
Maxillofac Surg  Off J Am  Assoc Oral Maxillofac Surg. 2007 Jul;65(7):1315–20.  
14.  
Isiordia-Espinoza MA, Pozos-Guillén AJ, Martínez-Rider R, Herrera-Abarca JE, Pérez-
Urizar J. Preemptive analgesic effectiveness of oral ketorolac plus local tramadol after  
impacted mandibular third molar surgery. Med Oral Patol Oral Cir Bucal. 2011 
Sep;16(6):e776-80.  
15.  
Isiordia-Espinoza MA, Sánchez-Prieto M, Tobías-Azúa F, Reyes-García JG, Granados-
Soto V. Pre-emptive analgesia with the combination of tramadol plus meloxicam for third  
molar surgery: a pilot study. Br J Oral Maxillofac Surg. 2012 Oct;50(7):673–7.  
16.  
Sethi P, Agarwal M, Chourasia HR, Singh MP. Effect of single dose pretreatment 
analgesia with three different analgesics on postoperative endodontic pain: A randomized 
clinical trial. J Conserv Dent. 2014 Nov;17(6):517–21.  
17.  
Jorge-Araújo ACA, Bortoluzzi MC, Baratto-Filho F, Santos FA, Pochapski MT. Effect of 
Premedication with Anti-inflammatory Drugs on Post-Endodontic Pain: A  Randomized 
Clinical Trial. Braz Dent J. 2018;29(3):254–60.  
18.  
Pereira G-M, Cota L-O-M, Lima R-P-E, Costa F-O. Effect of preemptive analgesia with 
ibuprofen in the control of postoperative pain in dental implant surgeries: A randomized, 
triple-blind controlled clinical trial. J Clin Exp Dent. 2020 Jan 1;12(1):e71–8.  
19.  
Hartling L, Ali S, Dryden DM, Chordiya P, Johnson DW, Plint AC, et al. How Safe Are 
Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review. 
Pain Res Manag. 2016/12/18. 2016;2016:5346819.  
20.  
Shafie L, Esmaili S, Parirokh M, Pardakhti A, Nakhaee N, Abbott P V., et al. Efficacy of 
Pre-Medication with Ibuprofen on Post-Operative Pain after Pulpotomy in Primary 
Molars. Iran Endod J. 13(2):216–20.  
 

 
 
30
21.  
Anderson BJ. Paracetamol (Acetaminophen): Mechanisms of action. In: A Practice of 
Anesthesia for Infants and Children. p. 915–21.  
22.  
Baygin O, Tuzuner T, Isik B, Kusgoz A, Tanriver M. Comparison of pre-emptive 
ibuprofen, paracetamol, and placebo administration in  reducing post-operative pain in 
primary tooth extraction. Int J Paediatr Dent. 2011 Jul;21(4):306–13.  
23.  
Rainsford KD. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology. 
2009 Dec;17(6):275–342.  
24.  
Goldman RD, Ko K, Linett LJ, Scolnik D. Antipyretic efficacy and safety of ibuprofen 
and acetaminophen in children. Ann Pharmacother. 2004 Jan;38(1):146–50.  
25.  
Kharouba J, Ratson T, Somri M, Blumer S. Preemptive Analgesia by Paracetamol, 
Ibuprofen or Placebo in Pediatric Dental Care:  A Randomized Controlled Study. J Clin 
Pediatr Dent. 2019;43(1):51–5.  
26.  
Santos PS, Massignan C, de Oliveira EV, Miranda Santana C, Bolan M, Cardoso M. Does 
the pre-emptive administration of paracetamol or ibuprofen reduce trans- and post-
operative pain in primary molar extraction? A randomized placebo-controlled clinical 
trial. Int J Paediatr Dent. 2020;30(6):782–90.  
27.  
Ashley PF, Parekh S, Moles DR, Anand P, Behbehani A. Preoperative analgesics for 
additional pain relief in children and adolescents having dental treatment. Cochrane 
database Syst Rev. 2012 Sep;(9):CD008392.  
28.  
Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental 
procedures for children. Pediatr Dent. 2013;35(1):52–4.  
29.  
Randall RC. Preformed metal crowns for primary and permanent molar teeth: review of 
the  literature. Pediatr Dent. 2002;24(5):489–500.  
30.  
American Academy of Pediatric Dentistry. Pediatric restorative dentistry. The Reference 
Manual of Pediatric Dentistry. Chicago, III. Am Acad Pediatr Dent. 2020;371–83.  
31.  
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. 
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel  
group randomised trials. Int J Surg. 2012;10(1):28–55.  
 
 
 

 
 
31
32.  
Viswanath A, Oreadi D, Finkelman M, Klein G, Papageorge M. Does Pre-Emptive 
Administration of Intravenous Ibuprofen (Caldolor) or Intravenous  Acetaminophen 
(Ofirmev) Reduce Postoperative Pain and Subsequent Narcotic Consumption After Third 
Molar Surgery? J oral Maxillofac Surg  Off J Am  Assoc Oral Maxillofac Surg. 2019 
Feb;77(2):262–70.  
33.  
Denyer M. Medical Statistics at a Glance. Vol. 216, Journal of Anatomy. 2010. p. 543.  
34.  
Aronson WL, McAuliffe MS, Miller K. Variability in the American Society of 
Anesthesiologists Physical Status  Classification Scale. AANA J. 2003 Aug;71(4):265–74.  
35.  
Riba H, Al-Zahrani S, Al-Buqmi N, Al-Jundi A. A Review of Behavior Evaluation Scales 
in Pediatric Dentistry and Suggested Modification to the Frankl Scale. EC Dent Sci . 
2017;16(6):269–75.  
36.  
Dean J, Jones J, LaQuia WV. Restorative Dentistry. In: McDonald and Avery’s Dentistry 
for the child and adolescent tenth edition. p. 185–205.  
37.  
Kratunova E, Silva D. Pulp therapy for primary and immature permanent teeth: An 
overview. Gen Dent. 2018;66(6):30–8.  
38.  
American Academy of Pediatric Dentistry. Pulp therapy for primary and immature 
permanent teeth. The Reference Manual of Pediatric Dentistry. Chicago, Ill. Am Acad 
Pediatr Dent. 2020;384–92.  
39.  
Hariri M, Ramdi H, El Alloussi M, Chhoul H. The Hall Technique: A Non-conventional 
Method for Managing Carious Primary Molars. Dentistry. 2016;6(7):385.  
40.  
Saghaei M. Random allocation software for parallel group randomized trials. BMC Med 
Res Methodol. 2004;4(1):26.  
41.  
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 
Mar;6(1):103–9.  
42.  
Wright GZ, Kupietzky A, Wright GZ. Behavior management in dentistry for children. 2nd 
ed. 2014.  
43.  
Peedikayil FC, Vijayan A. An update on local anesthesia for pediatric dental patients. 
Anesth essays Res. 2013;7(1):4–9.  
44.  
Leith R, Lynch K, O’Connell AC. Articaine use in children: a review. Eur Arch Paediatr 
Dent  Off J Eur Acad  Paediatr Dent. 2012 Dec;13(6):293–6.  
 

 
 
32
45.  
Kolli NKR, Nirmala SVSG, Nuvvula S. The Effectiveness of Articaine and Lidocaine 
Single Buccal Infiltration versus Conventional Buccal and Palatal Injection Using 
Lidocaine during Primary Maxillary Molar Extraction: A Randomized Control Trial. 
Anesth essays Res. 2017;11(1):160–4.  
46.  
Abu Sharkh M, Khalil A, Ong-Ly C, Wilson TD, Galil K. Buccal injection of articaine to 
anesthetize the palatal mucosa. Gen Dent. 2019;67(3):26–30.  
47.  
von Baeyer CL. Children’s self-reports of pain intensity: scale selection, limitations and 
interpretation. Pain Res Manag. 2006;11(3):157–62.  
48.  
Shuman MA. Extraction of Maxillary Teeth Without a Palatal Injection: A Randomized 
Control Trial. Egypt Dent J. 2020;66(Issue 4-October (Oral Surgery)):2085–90.  
49.  
Porritt J, Buchanan H, Hall M, Gilchrist F, Marshman Z. Assessing children’s dental 
anxiety: a systematic review of current measures. Community Dent Oral Epidemiol. 2013 
Apr;41(2):130–42.  
50.  
Leko J, Škrinjarić T, Goršeta K. Reliability and Validity of Scales for Assessing Child 
Dental Fear and Anxiety. Acta Stomatol Croat. 2020 Mar;54(1):22–31.  
51.  
Zeitoun S, Khalil A, Wahba N, Sayed M. The Use of a Respiratory Biofeedback Device to 
Reduce Dental Anxiety in Children: A Randomized Controlled Clinical Trial. Alexandria 
Dent J. 2021;0(0):0–0.  
52.  
Abu-Ghazaleh SB, Rajab LD, Sonbol HN, Aljafari AK, Elkarmi RF, Humphris G. The 
Arabic version of the modified dental anxiety scale. Psychometrics and normative  data 
for 15-16 year olds. Saudi Med J. 2011 Jul;32(7):725–9.  
53.  
Venham LL, Gaulin-Kremer E, Munster E, Bengston-Audia D, Cohan J. Interval rating 
scales for children’s dental anxiety and uncooperative behavior. Pediatr Dent. 2(3):195–
202.  
54.  
World Medical Association Declaration of Helsinki: ethical principles for medical  
research involving human subjects. JAMA. 2013 Nov;310(20):2191–4.  
 
 
 
 

 
 
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