NCT07087028

Digital vs. Conventional Anesthesia for Primary Tooth Extractions in Pediatric Patients

Comparison of Digital Anesthesia and Conventional Infiltration Techniques During Primary Tooth Extractions in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare two different techniques of administering dental anesthesia to pediatric patients to determine which method causes less pain and anxiety during procedures like primary tooth extractions.

Detailed description

Dental anxiety, particularly in pediatric patients, is a significant challenge, often triggered by fear of local anesthesia injections. Although local anesthesia aims to prevent pain during treatment, the injection process itself can cause anxiety and defensive behaviors, especially in children. To address this, various methods have been introduced to reduce discomfort, including topical anesthetics, slow injections, and thinner needles. However, traditional methods still face challenges in regulating injection rates, leading to the development of computer-controlled local anesthetic delivery (CCLAD) systems. CCLAD, particularly intraosseous anesthesia systems like SleeperOne™, offer a controlled flow rate and pressure during anesthesia delivery, potentially reducing discomfort and anxiety. Despite numerous studies, results on the effectiveness of CCLAD in pediatric patients remain controversial. This study aims to bridge this gap by comparing the efficacy of computerized intraosseous anesthesia with conventional infiltration anesthesia in pediatric patients undergoing primary molar extraction. The goal is to assess pain perception and anxiety levels, with the hypothesis that intraosseous anesthesia may lead to better outcomes in terms of pain and anxiety reduction compared to conventional techniques. The use of the SleeperOne™ device for intraosseous anesthesia is hypothesized to be more effective in reducing pain and anxiety compared to conventional infiltration techniques during the extraction of primary molars in children.

Conditions

• Pain Management
• Dental Anxiety
• Pediatric Dentistry
• Dental Anesthesia

Interventions

Type	Name	Description
DEVICE	SleeperOne™	Computerized intraosseous anesthesia was delivered using the SleeperOne™ (Dental HiTec, France) device with a 30 G × 9 mm Effitec needle at a 15° angle to the mucosa. A total of 2 mL 2% articaine with 1:100,000 epinephrine was administered per site.
OTHER	Conventional Infiltration Anesthesia	The intervention for the Conventional Infiltration Anesthesia involves the manual administration of a local anesthetic using a standard dental syringe with a fine-gauge needle.

Timeline

• Start date: 2020-01-20
• Primary completion: 2022-01-02
• Completion: 2022-01-02
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: Turkey (Türkiye)