Evaluation of the Effects of Computer-Controlled and Traditional Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization
Conditions: Molar-Incisor Hypomineralization
Sponsor: Canan Bayraktar Nahir

14.09.2023 
 
 
Official Title of the study: Evaluation of the Effects of Computer-Controlled and Traditional 
Local Anesthesia on Pain and Anxiety in Children With Molar Incisor Hypomineralization  
Organization's Unique Protocol ID: 23-KAEK-205 
NCT number: Not available 
Date of the document: 14.09.2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

14.09.2023 
Evaluation of the Effects of Computer-Controlled and Traditional Local Anesthesia on 
Pain and Anxiety in Children With Molar Incisor Hypomineralization  
Materials and Methods 
Ethics Approval: Ethical approval for this study was obtained from the Tokat Gaziosmanpaşa 
University Faculty of Medicine Clinical Research Ethics Committee (Approval No: 16-01 / Date: 
14.09.2023). The study was conducted in accordance with the principles of the Declaration of 
Helsinki. Before the procedures, detailed information about the study's purpose and the treatment 
to be performed was provided to the children and their parents, and both the child assent and 
informed consent forms were obtained. 
Determination of Sample Size: Using G*Power v.3.1.9.7, a power analysis for the planned study with 
2 dependent groups indicated that, with 80% test power (1–β) and an effect size of 0.56, 28 patients 
(56 permanent first molars) were planned to be included (Smaïl‐Faugeron et al., 2019).  
Participant Selection Criteria: The study included 28 children aged between 6 and 12 years who met 
the following criteria: absence of systemic disease; a score of 3 or 4 on the Frankl Behavior Rating 
Scale; bilateral MIH in the maxilla or mandible; deep dentin caries in the permanent first molars that 
could be treated with vital pulp therapy; and no history of acute pain. 
Study Design: The study was conducted using a split-mouth design with 28 patients and 56 teeth 
who met the inclusion criteria and were recruited from the Department of Pediatric Dentistry, 
Faculty of Dentistry, Tokat Gaziosmanpaşa University. The patients included in the study were 
randomly assigned to two groups: 
 
Control group: Anesthesia administered using the conventional injection technique. 
 
Study group: Intraosseous anesthesia administered with the computer-controlled anesthesia 
device (SleeperOne). 
Teeth affected by MIH were classified according to the Molar–Incisor Hypomineralization Treatment 
Need Index (MIH-TNI). Those in category 2 were evaluated as “Without hypersensitivity,” while those 
in category 4 were assessed as “With hypersensitivity” (Figure 1). 
Dental Anesthesia Methods: All procedures were performed by the same dentist in a single-unit 
room, and appointments were scheduled as the first of the morning (08:15). Patients were instructed 
to arrive with a full stomach and brushed teeth. Before the procedure, all steps were explained using 
the tell–show–do technique. 
All treatments were planned in two sessions, scheduled 7–10 days apart. The anesthesia method to 
be used in the first session was determined by randomization. For this purpose, each patient was 
asked to randomly select one of the envelopes labeled with different anesthesia methods. In 
addition, to determine which tooth to begin treatment on, patients were asked to choose between 
blue and green cards: children who selected the blue card started with the right first molar, while 
those who selected the green card started with the left first molar. 
In both the control and study groups, a topical anesthetic spray containing 10% lidocaine (Vemcaine® 
pump spray 10%, Vem Pharmaceutical Industry and Trade Co., Türkiye) was applied to the target 
area with a cotton pellet for 1 minute before anesthesia administration. In the control group, 
anesthesia was administered using a 2 ml plastic dental syringe (Berika Technology Medical 
Manufacturing Import Export Trade Co., Türkiye) for both infiltration and mandibular block 

14.09.2023 
anesthesia. For the maxillary teeth, buccal infiltration anesthesia was administered; for the 
mandibular teeth, mandibular block anesthesia was administered. In the study group, anesthesia was 
performed using a computer-controlled local anesthesia system with 30-gauge, 9 mm Effitec extra-
short needles (Dental Hi Tec, ZI de l’Appentière, Mazières-en-Mauges, France). Following topical 
anesthesia, half of a carpule of local anesthetic solution (Ultracaine D-S Fort, Sanofi Aventis 
Deutschland, Frankfurt, Germany) was administered to the designated teeth using the intraosseous 
anesthesia technique, in accordance with the manufacturer’s instructions. 
Dental Pain and Anxiety Assessment Scales: To evaluate the dental anxiety levels of the patients, the 
CFSS-DS (Children’s Fear Survey Schedule–Dental Subscale) was administered at their first visit. This 
scale includes 15 questions directed to the child, each answered on a 5-point scale ranging from 1 
(“not afraid at all”) to 5 (“very afraid”). The total score ranges from 15 to 75. Based on the total 
score, children scoring between 15 and 38 were considered not to have dental anxiety, while scores 
of 38 and above were considered indicative of dental anxiety. 
WBS, VAS, and FLACC scales were administered to the patients before anesthesia, after anesthesia, 
and after the treatment procedure. During the same periods, pulse rate and oxygen saturation were 
measured using a fingertip pulse oximeter device. 
Salivary Cortisol Measurements: 15 minutes before anesthesia, 15 minutes after anesthesia and 
after the treatment procedure, patients were instructed to rinse their mouths with water and then 
spit into a saliva collection container. Since cortisol measurements were to be performed on 
collected saliva, water was used as the rinsing solution to prevent interference from anesthetic 
agents or other chemicals with hormone levels. The collected saliva samples were transferred from 
the collection containers into 2 ml centrifuge tubes using pipettes and centrifuged at 5000 rpm for 10 
minutes. Using pipettes, the remaining saliva on top was transferred to Eppendorf tubes, and the 
samples were stored at -20 °C. The centrifugation process was completed within 5 minutes of sample 
collection. Salivary cortisol levels were measured in the Department of Medical Biochemistry, Faculty 
of Medicine, Tokat Gaziosmanpaşa University, using an ELISA kit (Salivary Cortisol Kit, BT LAB, 
Shanghai, China). 
Statistical Analysis: Data were analyzed using IBM SPSS version 23. The normality of data distribution 
was assessed with the Shapiro–Wilk test. For normally distributed data, parametric tests 
(Independent Samples t-test, Paired Samples t-test, Repeated Measures ANOVA, Pearson 
correlation) were used; for non-normally distributed data, non-parametric tests (Mann–Whitney U 
test, Wilcoxon test, Friedman test, Spearman’s rho) were applied. For categorical variables, Fisher’s 
Exact test (with Monte Carlo correction), Marginal Homogeneity test, and Cochran’s Q test were 
used. Quantitative data were presented as mean ± standard deviation or median (min–max), while 
categorical data were expressed as frequency and percentage. A p-value of < 0.05 was considered 
statistically significant.