The Evaluation of the Effects of Computer-controlled Electronic Anesthesia Systems and Traditional Local Anesthesia Techniques, Along With Different Anesthetic Agents, on Pain and Anxiety Levels During Dental Treatments in Pediatric Patients: A Randomized Controlled Clinical Study
Phase: NA
Conditions: Traditional Local Anesthesia, Computer-controlled Electronic Anesthesia, Dental Anxiety, Anxiety in Children
Sponsor: Dicle University

12.07.2025 
 
STUDY PROTOCOL  
 
Evaluation of the effects of syringe-based and computer-controlled local 
anesthesia systems and different anesthetic agents on pain and anxiety in 
pediatric dental patients 
The study was approved by the Medical Ethics Committee of Harran University with 
report number HRÜ/25.06.54. 
This randomized controlled clinical trial will be conducted at the Department of Pediatric 
Dentistry, Faculty of Dentistry, Dicle University, located in Diyarbakır, Turkey. A total 
of 84 voluntary pediatric patients aged between 7 and 10 years who meet the defined 
eligibility criteria will be included in the study. These patients will be selected from those 
with primary molars requiring pulpotomy or pulpectomy treatment located in either the 
maxilla or mandible. 
Before any intervention, patients and their legal guardians will be fully informed about 
the study, and written informed consent will be obtained. The aim of this study is to 
evaluate and compare the effects of traditional local anesthesia techniques and computer-
controlled local anesthesia systems (SleeperOne® – intraosseous anesthesia) on 
children's pain and anxiety levels. 
According to a within-subject crossover design, both traditional (syringe-based) and 
computer-controlled anesthesia methods will be applied to the same patient, but on 
different sides of the mouth. This design allows for objective comparisons and minimizes 
inter-individual variability. A total of 42 patients will be included in each group, with 
each child serving as their own control. Local anesthesia will be administered to the teeth 
on either the left or right side depending on clinical indication. 
Primary and secondary outcome measures will include assessments of both physiological 
and psychological parameters. Pain and anxiety levels will be evaluated using a 
combination of psychometric, physiological, and biochemical methods. The 
measurements will include: 
Physiological Measurements: 
 
Heart rate (bpm) 
 
Oxygen saturation (SpO₂) 
 
Body temperature (°C) 
Psychometric Scales: 
 
Facial Image Scale (FIS) 
 
Visual Analog Scale (VAS) 

 
Wong-Baker Faces Pain Rating Scale (WBS) 
 
Modified Child Dental Anxiety Scale (MCDAS) 
 
Children’s Fear Survey Schedule – Dental Subscale (CFSS-DS) 
 
FLACC Behavioral Pain Assessment Scale (Face, Legs, Activity, Cry, 
Consolability) 
The data obtained from these assessments will be recorded for both groups and 
statistically analyzed to determine which local anesthesia technique is more effective in 
reducing pain and anxiety. 
Additionally, the heart rate, oxygen saturation, and body temperature of the operator 
performing the procedure will also be measured to evaluate the impact of digital and 
traditional anesthesia techniques on the dentist's stress and anxiety levels. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Patient Evaluation Form 
Patient Information 
Patient Name / Surname: 
 
Protocol No: 
 
Phone number 
 
Age / Sex: 
 
CFSS-DS Score: (measured only once, first visit) 
 
Operated Area: Maxilla or Mandible 
 
 
Visit 1 – Traditional or Digital  Anesthesia 
Measurements Patients (Before / During / After) 
Measurement 
Before 
During 
After 
Pulse Rate (bpm) 
 
 
 
Oxygen Saturation 
(%) 
 
 
 
Body Temperature 
(°C) 
 
 
 
 
Measurements Patients (Before / After) 
Measurement 
Before 
After 
Wong-Baker Score 
(WBS) 
 
 
Facial Image Scale 
(FIS) 
 
 
Measurements Patients (During only) 
Measurement 
During 
Visual Analog Scale (VAS) 
 
FLACC Scale 
 
 
 Measurements – Operator 
Measurement 
Before 
During 
After 
Pulse Rate (bpm) 
 
 
 
Oxygen Saturation 
(%) 
 
 
 
Body Temperature 
(°C) 
 
 
 
 

Visit 2 – Traditional or Digital Anesthesia 
Measurements Patients (Before / During / After) 
Measurement 
Before 
During 
After 
Pulse Rate (bpm) 
 
 
 
Oxygen Saturation 
(%) 
 
 
 
Body Temperature 
(°C) 
 
 
 
 
Measurements Patients (Before / After) 
Measurement 
Before 
After 
Wong-Baker Score 
(WBS) 
 
 
Facial Image Scale 
(FIS) 
 
 
Measurements Patients (During only) 
Measurement 
During 
Visual Analog Scale (VAS) 
 
FLACC Scale 
 
 Measurements – Operator 
Measurement 
Before 
During 
After 
Pulse Rate (bpm) 
 
 
 
Oxygen Saturation 
(%) 
 
 
 
Body Temperature 
(°C) 
 
 
 
 

Statistical Analysis 
The statistical analysis of the research data will be conducted using IBM SPSS Statistics 
for Windows, Version 21.0. Continuous variables will be presented as mean ± standard 
deviation (SD), median, minimum value, maximum value, correlation coefficient (r), 
coefficient of variation (CV%), 95% confidence interval (95% CI), consistency rate, and 
weighted kappa (κ). Categorical variables will be expressed as numbers and percentages 
(%). The Kolmogorov-Smirnov test will be used to assess the normality of data 
distribution. 
For data with normal distribution, comparisons between two groups will be performed 
using the Independent Samples t-test. For non-normally distributed data, the Mann-
Whitney U test will be used for comparisons involving two groups. Repeated Measures 
ANOVA will be applied for comparisons among more than two groups. 
For categorical data, intergroup comparisons will be performed using the Pearson Chi-
square (χ²) test, Yates-corrected Chi-square (χ²) test, Fisher’s exact test, McNemar test, 
Kendall's W test, and Cochran’s Q test (for k-related samples), as appropriate. 
The relationship between variables will be evaluated using Pearson or Spearman 
correlation analysis. Additional statistical analyses will be conducted if necessary. All 
hypotheses will be tested two-tailed, and a p-value ≤ 0.05 will be considered statistically 
significant. 
 
 
 
 
 
 
 
 
 
 
 

INFORMED CONSENT FORM FOR PARENTS 
(ICFP) 
STUDY TITLE: 
Evaluation of the effects of syringe-based and computer-controlled local anesthesia systems and 
different anesthetic agents on pain and anxiety in pediatric dental patients 
You are being invited to allow your child to participate in a research study. Participation in this 
study is entirely voluntary. Before you decide whether to participate, it is important that you 
understand why the research is being conducted and what it involves. This includes how your 
and your child’s information will be used, what procedures are involved, as well as any potential 
benefits, risks, or discomforts. Please take the time to read the following information carefully. 
If you agree to participate, please sign the Consent to Participate form at the end. You are free to 
withdraw from the study at any time without penalty. 
You will not receive any financial compensation for participation, nor will you be asked to make 
any financial or material contribution. All materials and costs related to the study will be covered 
by the researchers. 
STUDY OBJECTIVE: 
One of the greatest sources of fear in pediatric dental patients is the local anesthesia procedure, 
which significantly affects the acceptance of dental treatment. 
This study aims to evaluate the effects of different anesthetic agents administered via a 
computer-controlled anesthesia system (SleeperOne® – intraosseous anesthesia) and 
conventional local anesthesia techniques on pain and anxiety levels in children. 
STUDY PROCEDURES: 
Children who require dental treatment on either the left or right side of the jaw and meet the 
inclusion criteria will be included in this study. 
Both conventional local anesthesia and computer-controlled local anesthesia using the 
SleeperOne® (CCLAD) system will be applied to the same patient. 
Various devices, questionnaires, and analyses will be used to measure pain and anxiety levels for 
both techniques. 
POTENTIAL BENEFITS OF PARTICIPATION: 
Although your child may not directly benefit from participation, the data collected may contribute 
to scientific knowledge and benefit other children in similar situations. 
HOW WILL PERSONAL INFORMATION BE USED? 
No identifying personal information will be used other than the child’s age and gender. 
 

CONTACT INFORMATION FOR QUESTIONS AND CONCERNS: 
• Prof. Dr. Emin Caner TÜMEN – 0533 264 69 33 
• Res. Assist. Dt. Hasan Said ŞENER – 0530 150 73 94 
• Res. Assist. Dt. Merve GÜNGÖR – 0530 155 63 58 
Consent to Participate 
I have discussed the details of this study with the relevant researcher and all my questions have 
been answered satisfactorily. 
I have read and understood this informed consent document. I voluntarily agree to allow my 
child to participate in this research study. 
I understand that this consent does not override any applicable laws or regulations. 
The researcher has provided me with a copy of this consent form, including instructions on points 
to be considered during the study. 
Parent/Guardian Full Name:  
Date and Signature: 
Phone Number: 
Legal Guardian (if applicable):  
Full Name: 
Date and Signature:  
Phone Number: 
Researcher’s Full Name:  
Date and Signature: 
Address and Phone Number: 
 
 
 
 
 
 
 
 
 
 

INFORMED ASSENT FORM FOR CHILD 
VOLUNTEERS (IACF) 
STUDY TITLE: 
Evaluation of the effects of syringe-based and computer-controlled local anesthesia systems and 
different anesthetic agents on pain and anxiety in pediatric dental patients 
STUDY OBJECTIVE: 
One of the greatest sources of fear in pediatric dental patients is the local anesthesia procedure, 
and acceptance of dental treatment is largely dependent on overcoming this fear. 
This study aims to evaluate the effects of different anesthetic agents applied using a 
computer-controlled anesthesia system (SleeperOne® - intraosseous anesthesia) and 
conventional local anesthesia on pain and anxiety levels in children. 
STUDY PROCEDURES: 
Children who have treatment-needing teeth on either side of the jaw and meet the research 
criteria will be included in the study. Both conventional local anesthesia and the SleeperOne® 
computer-controlled local anesthesia system (CCLAD) will be applied to the same patient. 
Various devices, questionnaires, and analyses will be used to measure pain and anxiety levels in 
both procedures. 
WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATION? 
The information obtained from you and children in similar situations will contribute to scientific 
knowledge. 
HOW WILL MY PERSONAL INFORMATION BE USED? 
Only your age and gender will be used. No other personal identifying information will be 
collected or used. 
CONTACT INFORMATION FOR QUESTIONS AND CONCERNS: 
• Prof. Dr. Emin Caner TÜMEN – 0533 264 69 33 
• Res. Assist. Dt. Hasan Said ŞENER – 0530 150 73 94 
• Res. Assist. Dt. Merve GÜNGÖR – 0530 155 63 58 
Assent to Participate 
Before deciding to take part in this study, you should talk to your mom and dad and ask their 
opinion. We will also ask for their permission. Even if they say yes, you can still say no. It is your 
choice whether you want to be in the study or not. If you say no, nobody will be upset or angry 
with you. 
Even if you agree now, you can change your mind later. That’s okay too. If you decide not to 
participate, your doctors will still treat you just the same as always. 

If you have any questions now or later, you can ask me at any time. My phone number and 
address are written on this paper. If you want to be in this study, please write your name and 
sign below. You and your parents will get a copy of this form after you sign it. 
Child Volunteer Full Name: 
Date and Signature: 
Phone Number: 
Parent/Guardian Full Name: 
Date and Signature: 
Phone Number: 
Researcher’s Full Name: 
Date and Signature: 
Address and Phone Number: 
CONTACT INFORMATION FOR QUESTIONS AND CONCERNS: 
• Prof. Dr. Emin Caner TÜMEN – 0533 264 69 33 
• Res. Assist. Dt. Hasan Said ŞENER – 0530 150 73 94 
• Res. Assist. Dt. Merve GÜNGÖR – 0530 155 63 58 
Consent to Participate 
I have discussed the details of this study with the relevant researcher and all my questions have 
been answered satisfactorily. 
I have read and understood this informed consent document. I voluntarily agree to allow my 
child to participate in this research study. 
I understand that this consent does not override any applicable laws or regulations. 
The researcher has provided me with a copy of this consent form, including instructions on points 
to be considered during the study. 
 
Parent/Guardian Full Name:  
Date and Signature: 
Phone Number: 
Legal Guardian (if applicable): 
Full Name: 
Date and Signature: 
Phone Number: 
Researcher’s Full Name:  
Date and Signature: