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

NCT07087028 | Completed

• 1 other identifier: 16-3/7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Dental Anxiety; Pediatric Dentistry; Dental Anesthesia

Outcome Measures

Primary Outcomes (3)

• Pain Perception - Visual Analogue Scale

  Pain was assessed using a 10-centimeter Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

  During anesthesia and during extraction in each visit.

• Pain Perception - Wong-Baker Faces Pain Rating Scale

  Pain was assessed using the Wong-Baker Faces Pain Rating Scale (WBPRS), which ranges from 0 (no hurt) to 10 (hurts worst). Higher scores indicate worse pain.

  During anesthesia and during extraction in each visit.

• Dental Anxiety - State-Trait Anxiety Inventory for Children - State Subscale

  Dental anxiety was assessed using the short form of the State-Trait Anxiety Inventory for Children - State Subscale (STAI-S). Scores range from 10 (low anxiety) to 40 (high anxiety).

  At baseline, after anesthesia and after extraction in each visit.

Secondary Outcomes (2)

• Physiological Arousal During Dental Procedure - Heart Rate

  Before anesthesia, during anesthesia, and during extraction in each visit.

• Baseline Dental Anxiety Assessed by Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)

  At the baseline before starting first visit.

Study Arms (2)

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

EXPERIMENTAL

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.

Device: SleeperOne™; Other: Conventional Infiltration Anesthesia

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

EXPERIMENTAL

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.

Device: SleeperOne™; Other: Conventional Infiltration Anesthesia

Interventions

SleeperOne™ 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.

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

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

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: July 25, 2025
• Study Start: January 20, 2020
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)