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

NCT07156487 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Dicle University

    lead OTHER

Principal Investigators

  • Emin C Tümen · Dicle Universty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156487 on ClinicalTrials.gov