NCT07156487

Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Dicle University · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system. The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients? By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.

Detailed description

This randomized controlled clinical trial will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. The study will include 84 voluntary pediatric patients aged between 7 and 10 years who meet the eligibility criteria defined.These patients will be selected among those who present with a clinical need for pulpotomy or pulpectomy proce dures in their primary molar teeth located in either the upper or lower jaws. Prior to any intervention, patients and their legal guardians will be fully informed about the study, and written informed consent will be obtained. The study aims to evaluate and compare the impact of traditional local anesthesia techniques and computer-controlled local anesthetic delivery systems (CCLAD) on children's pain and anxiety levels during dental procedures. In 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 enables 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 teeth requiring treatment either on the left or right side, depending on the clinical indication. The primary and secondary outcome measures will include assessments of both physiological and psychological parameters. Pain and anxiety will be measured using a combination of psychometric, physiological, and biochemical evaluation methods. These include: Physiological measurements: heart rate, oxygen saturation (SpO₂) and body temperature. 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 Scale (Face, Legs, Activity, Cry, Consolability) Data from these assessments will be recorded for both groups and analyzed to determine which anesthesia technique provides the best outcome in terms of minimizing pain and anxiety. Although this is not a patient registry study, quality assurance measures will be applied to ensure data integrity. These include: Regular validation checks for consistency and completeness during data entry. Source data verification against patient records and clinical forms. A standardized data dictionary defining all variables used, including their measurement units and coding schemes where applicable. Implementation of standard operating procedures (SOPs) for participant enrollment, data collection, safety monitoring, and data management. Statistical analyses will be planned according to a predefined protocol, using appropriate tests to evaluate differences between interventions. A sample size calculation has been performed to ensure that 84 patients are sufficient to detect clinically significant differences. A missing data management plan is in place to handle incomplete or inconsistent entries, ensuring statistical robustness and data quality. This study is expected to contribute valuable evidence to the field of pediatric dentistry by identifying the most effective and child-friendly local anesthesia method, thereby improving patient care and treatment experiences.

Conditions

• Traditional Local Anesthesia
• Computer-controlled Electronic Anesthesia
• Dental Anxiety
• Anxiety in Children

Interventions

Type	Name	Description
DEVICE	Digital Anesthesia with SleeperOne 5	For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.
DEVICE	Infiltration Anesthesia with a Metal Cartridge Syringe	For maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.
DEVICE	Mandibular Block Anesthesia with a Metal Cartridge Syringe	For mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: Turkey (Türkiye)