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Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia

NCT07585812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-14

No results posted yet for this study

Summary

This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children.

Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order.

Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded.

The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.

Conditions

  • Dental Anxiety
  • Dental Pain
  • Pulpotomy
  • Local Anesthesia

Interventions

DEVICE

Comfort-in Needle-Free Injection System

The Comfort-in needle-free injection system was used to administer local anesthetic solution without needle penetration. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in system before pulpotomy treatment of the primary first molar.

PROCEDURE

Conventional Dental Injection

Conventional local anesthesia was administered using a dental injector. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using a 27-gauge dental injector before pulpotomy treatment of the primary first molar.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Sema Aydinoglu, DDS, PhD · Recep Tayyip Erdogan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

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 NCT07585812 on ClinicalTrials.gov