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

Dicle University

Status: Not yet enrolling

Conditions: Dental Anxiety; Computer-controlled Electronic Anesthesia; Traditional Local Anesthesia; Anxiety in Children

Treatments: Device: Infiltration Anesthesia with a Metal Cartridge Syringe; Device: Digital Anesthesia with SleeperOne 5; Device: Mandibular Block Anesthesia with a Metal Cartridge Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT07156487

HRÜ/25.06.54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients classified as ASA I in general systemic health

  • Children between 7 and 10 years of age
  • Absence of any syndromic condition
  • No physical or mental disability
  • No prior dental treatment experience
  • Frankl Behavior Rating Scale Class III or IV
  • Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides
  • Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides
  • Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs

Exclusion criteria

• Patients with mild or severe systemic diseases or those undergoing medical treatment

  • Patients younger than 7 or older than 10 years of age
  • Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
  • Patients requiring urgent dental treatment
  • Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces
  • Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw
  • Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border
  • Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery)

Experimental group

Description:

For Maxillary Teeth: For maxillary teeth, the SleeperOne® 5 electronic local anesthesia system was used. After confirming pulp vitality through a cold or electric pulp test, the target area was dried, and 10% lidocaine topical anesthetic was applied for 1 minute using a cotton pellet. Then, 1.7 ml of Ultracaine D-S Fort was delivered via intraosseous injection using a 30-gauge, 9 mm Effitec needle in pediatric mode. For Mandibular Teeth: For mandibular teeth, the SleeperOne® 5 electronic local anesthesia system was used to perform intraosseous injection in pediatric mode. Prior to the injection, pulp vitality was assessed using a cold or electric pulp test. The injection site was then dried, and 10% lidocaine topical anesthetic spray was applied with a cotton pellet for 1 minute. Following this, 1.7 ml of Ultracaine D-S Fort was administered using a 30-gauge, 9 mm Effitec needle.

Treatment:

Device: Digital Anesthesia with SleeperOne 5

Traditional Local anesthesia Techniques

Active Comparator group

Description:

For the contralateral maxillary teeth: After confirming vitality, the site is dried and 10% lidocaine spray is applied for 1 minute. Buccal infiltration is performed. The cheek and lip are retracted, mucosa tightened, and the needle inserted at the tooth apex. After bone contact, the needle is withdrawn 1 mm, aspirated, and Ultracaine D-S Fort injected slowly over 1 minute using a 30G, 16 mm Effitec needle and metal carpule syringe. For the contralateral mandibular teeth: The retromolar area is dried, and 10% lidocaine spray is applied with a cotton pellet for 1 minute. After retracting the cheek and lip, the needle is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with the contralateral molars. After bone contact, aspiration is performed. Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe and a 27-gauge, 35 mm Effitec needle following the standard inferior alveolar nerve block technique.

Treatment:

Device: Mandibular Block Anesthesia with a Metal Cartridge Syringe

Device: Infiltration Anesthesia with a Metal Cartridge Syringe