Effectiveness of Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Mandibular Primary Molars: Randomised Controlled Clinical Trial
Phase: NA
Conditions: Local Anaesthetic Drug Adverse Reaction
Sponsor: Alexandria University

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OUTLINE 
Content 
Page 
− ABSTRACT 
1 
− INTRODUCTION 
2 
− AIM OF THE STUDY 
6 
− RESEARCH DESIGN 
7  
− PLAN OF THE STUDY 
8 
− STATISTICAL ANALYSIS 
17 
− ETHICAL CONSIDERATIONS 
18 
− PROBLEMS ANTICIPATED 
19 
− DURATION OF STUDY 
20 
− ESTIMATED BUDGET 
21 
− ROLE OF SUPERVISORS 
22 
− PUBLICATION POLICY 
23 
− APPENDICES 
24 
− REFERENCES 
26 

1 
 
ABSTRACT 
Background: Exodontia poses a psychological threat for children, increasing the need for 
profound local anesthesia to assure painless extraction and maintain child cooperation on the 
dental chair. Computer-controlled Intraligamentary anesthesia (CC-ILA) affects only the tooth 
to be treated with minimal pressure, eliminating the side effects of other conventional techniques.  
Purpose of the study: To evaluate the effectiveness of CC-ILA injection in eliminating pain 
during extraction of mandibular primary molars compared to inferior alveolar nerve block 
(IANB) technique. 
Method: The study will be a double-blind randomized controlled clinical trial, parallel design. 
A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and 
Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children 
will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have 
at least one mandibular primary molar that is indicated for extraction. Written informed consent 
will be obtained from guardian. Participants will be randomly allocated into two groups 
according to the technique of anesthesia that will be used. Group I (test group) will receive CC-
ILA, while group II (control group) will receive IANB. Heart rate will be used as vital parameter 
of pain, and will be recorded at base line, during injection and during extraction procedure. Pain 
reaction will be assessed objectively by two investigators using Sensory, Eye, Motor (SEM) 
scale, while subjectively the pain will be evaluated by asking the child to express his experience 
using a modified face scale from the Maunuksela scale. 
 
Results: Data will be collected, tabulated and statistically analysed to obtain the results and 
conclusions of this study. 
Keywords: Computer – controlled, Intraligamentary, Local anesthesia, Nerve block, Articaine, 
Pain, Extraction. 
 
 

2 
INTRODUCTION 
Child management is a primary challenge facing pediatric dentists routinely. Uncooperative 
behaviour can significantly affect treatment quality, time, and increase the possibility of child injury 
during treatment as mentioned by Ingersoll and Ingersoll.(1) Acknowledgement of various behaviour 
management techniques, operating skills, and most importantly providing profound local anaesthesia 
are critical to deliver high quality dental service.(2)  
Local anaesthetic (LA) forms the backbone of pain control techniques in dentistry. Although 
it is considered one of the painful procedures in daily dental practice, especially for children, 
however, its obligatory to use LA to eliminate pain during the various dental procedures and maintain 
child cooperation during the dental session.  
Pain is defined by The International Association for the Study of Pain Subcommittee on 
Taxonomy in 1979 as “the unpleasant sensory and emotional experience arising from actual or 
potential tissue damage.”(3, 4) Profound LA facilitates successful restorative and surgical treatment. 
Exodontia is one of the procedures that demand profound local dental anaesthesia to control high 
levels of pain and stress and reduce adverse reactions.(5) 
A rapidly acting, potent LA drug is the gold standard. In the late 1940s, a new group of 
local anesthetic compounds, the amides, was introduced. The initial amide local anesthetic, 
Lidocaine, was used for pain control in dentistry worldwide.(6) Later in the mid-1970s, Articaine, 
a more potent Amide-type LA drug was first introduced in  Germany by Rusching et al,(7) then 
in 2000 by the US Food and Drug Administration (FDA), and later in 2004, it has been approved 
by the Therapeutics Goods Administration for clinical use in Australia.(8)  
Articaine is 1.5 times more potent than lidocaine;(9) its unique chemical composition 
enhances its lipid solubility, which increases its uptake by neurones providing an early onset.(10) 
Malamed (2000)(11) stated that Articaine 4% with epinephrine 1:100,000 provides total pain 
relief during most dental procedures, as it can effectively penetrate soft and hard tissues and is 
highly diffusible compared to other local anesthetics.(8) However, it is only available in high 
concentrations. Therefore, it is not recommended for children less than 4 years.(9, 12)  

3 
 
A study conducted by Vika and Skaret (2008)(13) reported that LA injections seemed to cause 
more anxiety than the treatment process itself, and may even lead to completely avoiding treatment. 
Therefore, pediatric dentists are always searching for the least painful LA technique to reduce pain, 
anxiety and maintain child cooperation.  
Historically, the Inferior Alveolar Nerve Block (IANB) is the technique of choice for 
anaesthetising mandibular primary and permanent molars.(14, 15) It provides anesthesia to all 
tissue innervated by the including teeth, bone, lip, gingiva, and mucous membrane up to the 
midline of the related part. Due to the proximity of the Lingual nerve, it is also anaesthetized by 
the same injection, so the lingual side of the gingiva, the floor of the mouth and anterior two 
thirds of the tongue become numb.  
As the IANB anesthetizes a wide area other than the teeth, patients encounter loss of 
sensitivity, as well as total or partial loss of function of the facial muscles and tongue for the 
duration of the anaesthesia which may last up to two hours.(10) Temporary hindering of patients’ 
daily life with limited speech ability, eating, and most importantly, the risk of cheeks and lip 
biting are major drawback of this technique. Moreover, a rare but major complication of IANB 
anaesthesia is the injury of the mandibular nerve that could result in permanent impairment of 
the nerve function.(11,12) 
In an attempt to overcome the limitations of the IANB technique, other methods have 
been advocated such as Intraligamentary Anaesthesia (ILA). This technique was introduced by 
Chompret (1920).(16) Intraligamentary Anaesthesia is a method of intra osseous injection with LA 
reaching the cancellous space in the bone via the periodontal ligament (PDL).  
Intraligamentary Anaesthesia can be a very effective alternative technique in children, as it 
can help lessen the struggle of achieving successful anaesthesia during single tooth treatment.(17, 18) 
It can have superior features in cases where anatomical variations are present and eliminating soft 
tissue injury which is a major concern while using other techniques. Moreover, it aids in treatment 
if teeth in different quadrants that are being summoned in a single visit, which helps both pediatric 
dentist and the child to avoid management complications associated with multiple dental visits. 
Many studies have proven that ILA does not cause any secondary complications if carefully applied. 
It causes very little pain if at all, rapid onset and allowing to start the dental work immediately.(19) 

4 
 
Nevertheless, it is believed that ILA has higher levels of post-operative pain than conventional 
techniques, and its duration only lasts for around 20 minutes.(20-22) Two studies reported periodontal 
abscesses and deep pocket formation after ILA.(23, 24) Hence, it should not be used for children 
suffering from cardiovascular problems as they are at more risk of developing subacute bacterial 
endocarditis.(25, 26) 
Intraligamentary Anaesthesia is delivered manually via conventional, or high-pressure 
syringes,(27) or using computer-controlled local anaesthetic delivery systems (CCLADS).(28) 
There are some potential problems with the conventional intraligamentary technique. One such 
problem is the high pressure required to inject the anesthetic solution, which may lead to 
breakage of the glass cartridge with a conventional syringe.(29) 
The Wand-STA Single Tooth Anaethesia is a CCLADS launched in 2006 by the 
manufacturers of the Wand Compudent system.(30) It’s the only delivery system with 
incorporated dynamic pressure sensing (DPS) technology to monitor real-time pressure.(31) It is 
capable of identifying the periodontal ligament tissue and enables the clinician to maintain the 
correct needle position within the periodontal ligament when performing ILA. Developed by Dr. 
Mark Hochman, the STA-Intraligamentary Injection represents a new concept in local dental 
anesthesia techniques.(32) 
The system is activated by a foot control that allows a more precise and accurate LA 
delivery at a decreased steady pressure and volume via the intraligamentary route, regardless of 
the tissue resistance. This helps reduce tissue distortion and thus potentially minimizing the 
painful experience of ILA. However, it is signiﬁcantly more expensive than a PDL-syringe and 
handling of the STA system may be complex for less trained dentists.(33) 
 
Garret-Bernardin and Cantile (2017)(34) showed that computerized injections are better 
tolerated and reduced pain perception in 7 – 15 year old patients compared to the traditional 
syringe during routine dental treatment.(35) In another study conducted on primary teeth, Tekin and 
Ersin (2012)(36)reported that  a significantly higher mean Sound, Eye and Motor (SEM) score of 
pain reaction for IANB group was recorded in comparison to conventional ILA during both injection 
and extraction periods of mandibular primary teeth (p < 0.005). 
 
 
 

5 
 
Various studies report adequate anesthesia with computer controlled intraligamentary 
injection for primary tooth cavity preparation and pulpectomy as well as permanent tooth 
extraction.(29, 33, 37-39) However, limited studies have been conducted to evaluate the efficacy of 
computer-controlled-ILA (CC-ILA) for extraction of primary molars.(30)  
 
This study will compare the pain experience of the experimental group (CC-ILA) and control 
group (conventional injection by IANB) during injection and its effectiveness in eliminating pain 
during extraction of mandibular primary molars in pediatric patients. The null hypothesis is there 
will be no difference in the pain experience with the use of CC-ILA compared to the IANB in 
pediatric patients. 

6 
AIM OF THE STUDY 
Primary aim: 
•
To evaluate the effectiveness of computer – controlled Intraligamentary Anaesthesia in
eliminating pain during extraction of primary mandibular molars compared to Inferior
Alveolar Nerve Block.
Secondary aims: 
•
To assess and compare the pain experience during Local Anaesthesia injection of
mandibular primary molars between computer – controlled Intraligamentary
Anaesthesia and conventional Inferior Alveolar Nerve Block.
•
To assess and compare the pain experience during extraction of mandibular primary
molars when using the two different anaesthesia techniques.
•
To record the occurrence of any adverse events.

7 
 
RESEARCH DESIGN 
      
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
Figure (1): Flow Chart Study Design 
 
Random allocation 
Group I 
Computer controlled - Intraligamentary 
injection (CC-ILA)                     
(n =25)                              
Group II 
 Inferior alveolar nerve block 
(IANB)                           
(n = 25) 
Intervention 
Randomized Controlled Clinical trial 
Participants assessed for eligibility N=50    
aged 5-7 years 
Statistical analysis n=50 
Excluded participants 
Group II 
 Baseline HR                   
Receive IANB injection         
(n = 25)                      
 HR, SEM, Faces pain scale 
Extraction of Mandibular Primary 
Molars                              
 HR, SEM, Faces pain scale 
Group I  
 Baseline HR                   
Receive CC-ILA               
(n =25)                       
 HR, SEM, Faces pain scale 
Data collection 
Follow up                 
(24 hours) 

8 
 
PLAN OF THE STUDY 
Study design 
The study will be a two-arm randomized controlled clinical trial. It will be setup  and  reported  
according  to  the  CONSORT  guidelines.(40) The PICOT question will be: do pediatric patients aged 
from 5-7 years (Population; P) assigned to receive CC-ILA (Intervention; I) in comparison to inferior 
alveolar nerve block conventional injection (Control; C) show less pain during injection and 
extraction of mandibular primary molars (outcome; O) in twenty-four hours (time; T)? 
 
Study setting and location 
Participants will be recruited from Pediatric Dentistry and Dental Public Health 
Department, Faculty of Dentistry, Alexandria University, Egypt. 
 
Sample size estimation 
The sample size was calculated based on results obtained from previous studies of similar 
nature. Sample size was estimated assuming alpha error= 5% and study power= 80%. Tekin et 
al (36) reported mean ± SD Sound, Eye and Motor (SEM) score = 3.93 ± 1.223 when 
intraligamentary anesthesia (ILA) was used, and 5.17 ± 1.891 when inferior alveolar nerve 
block (IANB) was used. Based on comparison of means, sample size was calculated to be 25 
per group, and the total sample size required to compare the effectiveness of CC-ILA technique 
versus IANB during extraction of primary mandibular molars = number of groups × number 
per group= 2 x 25 = 50.(41) The sample size was calculated using powerandsamplesize.com 
calculator.(42)  
 
Criteria for sample selection:  
a) Eligibility Criteria  
• Age range from 5 – 7 years. 
• Children free of any systemic disease or special health care need (ASA I).(43) 
• No previous bad dental experience.(44) 
• Positive or definitely positive behaviour during preoperative assessments according to the 
Frankl Rating Scale (score 3 or 4) (Appendix I).(45) 
 

9 
• Patients whom their mandibular primary molars are indicated for extraction:(46, 47)
o
Clinical signs and symptoms of pulp degeneration, such as swelling or sinus tracts.
o
Radiographic evidence of periapical or interradicular radiolucency.
o
Non restorable crowns.
o
Failed pulpotomies.
• Patients whose parents will give their consent to participate.
b) Exclusion Criteria for teeth (48)
• Root resorption affecting more than one third of the root length.
• Fractured roots due to trauma.
• Signs of mobility.
• Ankylosed roots.
•
Active sites of pathosis in area of injection that could affect anaesthetic assessment.
•
History of allergy to local anesthesia.
Materials 
a) Topical Anaesthesia – Benzocaine gel 20%.*
b) 27-guage long anaesthetic needles.**
b) Local anaesthetic carpules: Articaine hydrochloride 4% with adrenaline 1:100,000.***
c) Equipment:
• Wand - STA Single Tooth Anaesthesia Device (Figure 2)****
• Disposable Wand – STA Handpieces with 30-guage 0.5-inch needles. ****
• Pulse oximeter.*****
• Dental anaesthetic syringe (non-disposable breech loading, metallic cartridge type).******
• Lower Full-crown Extraction forceps.*******
* Dharma Research, Inc. 5220 NW 72nd Ave Miami, FL 33166 USA.
** C-K Ject, CK Dental Ind. Co., LTD., Korea. 
*** ARTINIBSA, Inibsa Dental S.L.U, 08185 Lliçà de Vall, Barcelona, Spain. 
**** STA; Milestone Scientiﬁc, Inc., Livingston, NJ, USA 
***** Zacurate,10101 Stafford Centre Dr. Ste B Stafford, Texas, USA. 
****** BeehiveSolutionsLtd:10aHighview Parade. Woodford Avenue. Ilford. Essex. UK. 
******* Likamed Plot # 117/2 A Model Town Ugoki, Sialkot, Pakistan. 

10 
Figure (2): Wand - STA Single Tooth Anaesthesia Device 
Randomization 
Participants complying with the inclusion criteria will be randomly assigned using a 
computer-generated list of random numbers.(49)  
Allocation concealment
Each child included in the study will be given a serial number that will be used in the 
allocation. These numbers will be written in identical sheets of paper with the group to which each 
child is allocated and placed inside opaque envelopes carrying the respective names of the 
children.(50) A trial independent personnel will be assigned to the role of keeping the envelopes and 
unfolding them only at the time of the local anesthesia injection session so that the group the child 
is allocated to is concealed from the outcome evaluator. 
Grouping 
Participants will be randomly and equally allocated to one of the two arms (Figure 1). 
•
Group I: (experimental group n = 25) assigned to CC-ILA.
•
Group II: (control group n = 25) assigned to conventional injection by IANB.

11 
Blinding 
The researcher (operator) who will perform all the injections and extractions as well as 
record heart rate measurements cannot be blinded to the type of intervention; a second impartial 
observer (evaluator) will record the Sensory, Eye, Motor (SEM) scale independently.(30) The 
statistician will be blinded to the treatment groups. Since the participants will also be blinded, 
therefore, the study will be triple-blind. 
Examiner reliability 
• For standardization, all clinical procedures will be performed by a single operator, who will
be trained and calibrated for the Wand – STA system via training sessions by an expert
through the manufacturing company, as it is too complex to be applied effectively without
more appropriate training. Especially, the coordination between the foot pedal handling and
the syringe has shown to be difficult.(33)
• Training on heart rate measurement using the pulse oximeter will be also planned.
• The second observer will be trained separately to assess pain using (SEM) scale by observing
children undergoing dental procedures and classifying the child’s behavior on videotapes.
After a 7-day interval, the exercise will be repeated in order to develop an acceptable degree
of examiner reliability. Intra-examiner reliability will be tested by Intraclass correlation
(ICC).(51)
Clinical Procedure
Preliminary screening visit 
• Full medical and dental history will be carried out to select patients. Those patients whose
parents will give their consent to participate will be examined.(52) Proper diagnosis with
thorough clinical examination, and intraoral periapical radiograph of the tooth to be extracted
will be taken to ensure that the patient will match the inclusion criteria.
Patient Preparation (53) 
• The child’s dental visit will be a mean of introducing dentistry and acquainting the child to
the dental unit and dental instruments using ‘Tell Show Do’ technique. No treatment will be
done to the child in order to build a strong patient-dentist relationship.(54)

12 
Intervention Visit 
Psychological child preparation: 
• The children will be told that their teeth will be put to sleep after placing some jelly and feeling
a little pinch, in order to get rid of germs.
• Audible sounds will be heard while using STA in group I, so they must be informed.
• Subjects in Group II (IANB) will be told that their cheek will feel big and funny for some time.
• The procedure will be videotaped as a method of motivation to document their good behaviour.
• Patients will be positioned in supine position with the head and chest parallel to the floor and
the feet slightly elevated.
• Mouth props may aid in maintaining a wide mouth opening.
• For both groups, soft tissues will be dried using (2 x 2 cm) gauze to enhance the absorption of
the topical anaesthetic. Twenty percent Benzocaine topical anaesthetic gel will be used to obtund
the discomfort associated with needle insertion. It will be applied at the site of needle penetration
and left in contact with the soft tissues for one minute to optimise its effect.
Local Anaesthesia Administration 
a) Wand-STA system:
• In the experimental group, CC-ILA will be administered using the Wand-STA system according
to the manufacturer instructions, which is also concurrent with Mittal and Chopra (2019)(30). It
works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual
line angles are the most effective for multi-rooted mandibular teeth.
• The injection is initiated by activating the STA mode when the foot control is tapped. A 30-
gauge ultra-short disposable dental needle will be inserted in the PDL through the gingival sulcus
at the distolingual line angle of the target tooth first, guided by constant audible tones and visual
feedback. The needle should be directed approximately 30° angle to the long axis of the tooth
and the bevel facing the alveolar bone. A total of 0.9 mL Articaine hydrochloride 4% with
1:100,000 epinephrine will be injected for each root as shown on a special indicator.
• During the anaesthetic solution delivery, the visual pressure indicator will be observed as the
pressure is increasing from the red into the green zone. Tissue blanching may occur, which

13 
suggests that enough LA has been delivered. Injection will be stopped by lightly tapping the foot 
pedal again. The dentist will wait 5 seconds before needle withdrawal. Same steps will be 
repeated at the mesiolingual line angle.(31)  
b) Conventional technique:
• In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will
be used supplemented with long buccal infiltration for the buccal gingiva. While the mouth is
open as wide as possible, the index finger palpates the injection site.
• A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with
1:100,000 epinephrine. The needle will be directed between the two primary molars on the
opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly
lower until bony resistance is met.
• The needle is withdrawn 2mm to aspirate. Once negative aspiration is checked, the remainder
of the solution is slowly deposited. The lip and/or cheek will be shaken as a method of
distraction. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve.(36)
Two-thirds the needle length should be inserted.
• The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary
molar is administered.(55)
• The operator will wait for 3-5 minutes before commencing dental treatment. Numbness will
be tested with a dental probe on the gingiva immediately following the injection, and after
each 10 seconds in case of CC-ILA and each 30 seconds in case of IANB till full numbness is
declared and the time of onset of the anaesthetic effect will be noticed.
• In both groups, extraction will be accomplished according to AAPD guidelines.(56) Lower full
crown forceps will be used to apply slow continuous palatal/lingual and buccal force allowing
for the expansion of the alveolar bone to accommodate the divergent roots and reduce the risk
of root fracture.
• Care will be taken to support the mandible with the non-extraction hand.
• If the patient suffered pain at any given time in the experimental group, the procedure will be
abandoned immediately, IANB will be administered, and extraction will be carried out.

14 
• Post extraction instructions will be given to the patient. They will be instructed to bite on
gauze with firm pressure against the surgical site for 30 minutes. They should not disturb the
surgical site or rinse vigorously on the day of extraction. According to the technique used,
avoid scratching, or injuring the cheek, lips, or tongue if numbness is felt. They should avoid
any physical exercise on the day of extraction. Cold soft food is recommended, as well as
drinks to keep the child hydrated but without using a straw.
• Analgesics and/or antibiotics will be prescribed if required.
• Planning for space maintenance will be considered as well. All dental injections and
extractions will be administered by the same operator, who will be assisted by a trained dental
assistant.
Follow up 
Following extraction, follow up after 24-hours will be planned via telephone calls to 
assess any adverse events.  
Study Outcomes 
I. Assessment of Child Pain Reaction 
In the present study, pain will be assessed using the following 3 methods: 
A. Physiologic method: 
Heart rate (HR) is a physiological sign of pain.(57) It will be measured using a pulse 
oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be 
instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The 
pulse oximeter will be placed on the patient’s index finger to measure the baseline heart rate 
(before giving the LA), another measurement will be recorded during LA administration, and 
during extraction. Readings will be recorded at 2-minute intervals and the mean heart rate 
measurement will be calculated.  

15 
 
B. Objective method: 
 Sound, Eye, Motor (SEM) Scale (Figure 3), will be used as an objective method for 
pain assessment during LA administration and extraction. It comprises the following parameters: 
(1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements 
will be evaluated independently by a blind impartial observer using the recorded video tapes. The 
slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: 
comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, 
respectively. SEM score will be calculated by summing the three grades of the parameters. (58) 
 
 
 
 
Figure (3): SEM scale for the assessment of children’s behaviour 
 
 
Subjective method: 
A modified face scale(59) (Figure 4) from the Maunuksela et al(60) scale will be used to 
subjectively record pain during LA injection and extraction. It consists of three schematic 
faces with different facial expressions for happy and sad faces representing: (A) satisfaction; 
(B) indifference; and (C) dissatisfaction, respectively. Each child will be trained to use the 
scale by modelling and then asking each participant to think of the last time she/he felt 
something painful and to select the facial expression that best represented his/her experience of 
discomfort.  
Parameter 
Comfort  
Mild  
discomfort 
Moderate  
discomfort 
Severe  
discomfort 
Grade 
1 
2 
3 
4 
Sound 
No sound 
Non-specific sound 
(probable pain) 
Verbal complaint,  
louder sound 
Verbal complaint 
shouting, crying 
Eye 
No sign 
Dilated eye without 
tears (anxiety sign) 
Tears, sudden eye 
movements 
Crying, tears all over the 
face 
Motor 
Relaxed body 
and hand status 
Muscular contraction, 
contraction of hands 
Sudden body  
and hand movements 
Hand movements for 
defence, turning the head 
to the opposite side 

16 
 
 
Figure (4): Faces scale modified from the Maunuksela et al scale.                    
 (A) satisfaction; (B) indifference; and (C) dissatisfaction 
 
II. Assessment of occurrence of adverse events 
 
Parents will be recalled after 24 hours following extraction during follow-up phone 
calls. Recovery parameter questions will be asked to ascertain the occurrence of lip and cheek 
biting, post-operative pain, or any adverse events. 
 
 
 

17 
STATISTICAL ANALYSIS 
All data will be collected; descriptive quantitative values will be summarised using mean 
and standard deviation, while count and percentage will be used for qualitative values. The data 
will be represented by suitable tables and graphs. Comparing between normally distributed data 
will occur using T- and Paired T-tests, while for not – normally distributed data, Wilcoxon 
signed-rank and Mann-Whitney U tests will be used.  
All statistical analyses will be performed with statistical Package for Social Sciences* 
(SPSS) software version 21.(61) The significance level will be set at P <0.05. 
*SPSS Inc., Version 21.0, Chicago, IL, USA

18 
ETHICAL CONSIDERATIONS 
The study will be conducted following the ethical principles for medical research 
involving human subjects in Declaration of Helsinki.(62) Ethical approval will be obtained from 
the Research Ethics Committee, Faculty of Dentistry, Alexandria University before 
commencing 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. 
Parents and children will be given age-appropriate 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. Post extraction instructions will be explained well to the 
parents and patients to ensure good wound healing. All the possible clinical and/or adverse 
outcomes will be explained to the parents and they will be asked to report immediately if any of 
them occurs. 

19 
PROBLEMS ANTICIPATED 
1. Lack of compliance from patients and/or their parents.
2. Drop – out of patients during the follow up period.
3. Difficulty in collecting the proposed sample.
4. Difficulty in finding patients who fulfil the inclusion criteria of the study.
5. Negative behaviour of children due to the traumatic nature of the extraction procedure.

20 
DURATION OF THE STUDY 
Estimated time: 15 Months. 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 14 15 
Proposal writing  
 
Sample selection 
 
 
Dental 
procedure 
 
 
 
 
Data 
management 
and statistical 
analysis 
  
 
Writing thesis 
 
 
 
Thesis 
submission 
 
Months
Tasks

21 
ESTIMATED BUDGET 
Estimated total budget 21,000 LE 
Total 
price (LE)
 
Materials
 
No
 
11000
 
Equipment 
 
1 
2000
 
Statistical analysis
 
2 
2000
 
Computer services
 
3 
2000
 
Printing services
 
4 
3000
 
Publication cost
 
5 
1000
 
Others
 
6 
21000
 
Total 
 

22 
ROLE OF SUPERVISORS 
1. Assoc. Prof. Dr. Laila Moustafa El-Habashy
She will supervise the clinical work. 
She will also help the student in interpreting results and revising the thesis. 
2. Dr. Sarah Ibrahim Mohamed Zeitoun
She will supervise the clinical work. 
She will also help the student in interpreting results and revising the thesis. 

23 
PUBLICATION POLICY 
The study will be sent for either national or international journals for 
publication. 
In order of: 
1. Rodaina Hazem Mohamed Helmy
2. Laila Moustafa El-Habashy
3. Sarah Ibrahim Mohamed Zeitoun

24 
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 

26 
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27 
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Alexandria University 
Faculty of Dentistry 
Department of Pediatric Dentistry and  
Dental Public Health 
 
 
 
Faculty of Dentistry, Alexandria University, Champolion st., Azarita, Alexandria 21521, Egypt 
Tel: (203) 4868066/ 4869690 ext: 221-Fax: (203) 4868286 
 
 
 
EFFECTIVENESS OF COMPUTER - CONTROLLED INTRALIGAMENTARY 
LOCAL ANAESTHESIA IN EXTRACTION OF MANDIBULAR PRIMARY 
MOLARS (RANDOMISED CONTROLLED CLINICAL TRIAL) 
 
Name: Rodaina Hazem Mohamed Helmy 
 
Summary Statement 
Sample size was estimated assuming alpha error= 5% and study power= 80%. Tekin et al.(1) 
reported mean ± SD Sound, Eye and Motor (SEM) score = 3.93 ± 1.22 when 
intraligamentary anesthesia (ILA) was used, and 5.17 ± 1.89 when inferior alveolar nerve 
block (IANB) was used. Based on comparison of means, sample size was calculated to be 25 
per group, and the total number required to compare the effectiveness of computer-
controlled ILA technique versus IANB during extraction of primary mandibular molars = 
number of groups × number per group= 2 x 25 = 50.(2)  
 
Software 
http://powerandsamplesize.com/Calculators/Compare-2-Means/2-Sample-Equality.  
 
References 
1. Tekin U, Ersin N, Oncag O, Bent B, Menderes M, Kocanali B. Comparison of inferior 
alveolar nerve block and intraligamentary anesthesia on the discomfort of children. J 
Int Dent Med Res. 2012;5:143-8. 
2. Petrie A, Sabin C. Medical statistics at a glance.3rd ed. John Wiley & Sons, West 
Sussex, UK; 2009.  
 
 
 
Maha El Tantawi; B.D.S, M.Sc, Ph.D 
 
 
 
Professor of Dental Public Health 
Alexandria University 
Wednesday, January 20, 2021 

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