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

NCT ID: NCT07087028

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2022-01-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FIRST Computerized Intraosseous Anesthesia (CCIA), SECOND Traditional Infiltration Anesthesia (TIA)

In this randomized split-mouth crossover design, participants underwent two appointments for bilateral upper primary molar extractions. In this arm, at the first visit, computerized intraosseous anesthesia (CCIA) was administered using the SleeperOne™ system with a 30 G × 9 mm Effitec needle and 2% articaine with 1:100,000 epinephrine, followed by tooth extraction. At the second visit, conventional buccal infiltration anesthesia (TIA) was performed using a standard dental syringe and a 27-gauge needle on the contralateral molar, using the same anesthetic solution.

Group Type: EXPERIMENTAL

SleeperOne™

Intervention Type: DEVICE

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.

Conventional Infiltration Anesthesia

Intervention Type: OTHER

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.

FIRST Traditional Infiltration Anesthesia (TIA), SECOND (CCIA)

In this randomized split-mouth crossover design, participants underwent two appointments for bilateral upper primary molar extractions. In this arm, at the first visit, conventional buccal infiltration anesthesia (TIA) was administered using a standard dental syringe and a 27-gauge needle, along with 2% articaine containing 1:100,000 epinephrine. At the second visit, computerized intraosseous anesthesia (CCIA) was delivered using the SleeperOne™ system with a 30 G × 9 mm Effitec needle, followed by extraction of the contralateral molar using the same anesthetic solution.

Group Type: EXPERIMENTAL

SleeperOne™

Intervention Type: DEVICE

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.

Conventional Infiltration Anesthesia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients in between 6-12 years old
• Physically and mentally healthy patients
• Cooperative patients who were rated as positive or definitely positive according to the Frankl behavior classification scale
• Patients who had primary molars that required extraction on both sides of maxillary arch.

Exclusion Criteria

• Children allergic to local anesthetics
• Medically compromised and special children
• Teeth with hypoplasia
• Children who used analgesic drug 48 hours before treatment

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Özant Önçağ

Professsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

16-3/7

Identifier Type: -

Identifier Source: org_study_id