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Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children

NCT07548892 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a needle-free injection system can make tooth extraction less stressful for children than a conventional dental syringe. The study will include healthy children 6 to 12 years old who need a primary tooth extraction with buccal and lingual local anesthesia. The main questions are whether the needle-free method can lower anxiety, lower pain, and reduce changes in vital signs compared with the conventional syringe.

Researchers will randomly assign participants to 1 of 2 groups. One group will receive local anesthesia with a needle-free jet injection system. The other group will receive local anesthesia with a conventional syringe and a 27-gauge dental needle. In both groups, a topical lidocaine spray will be used before the injection, and the same anesthetic solution will be given. All tooth extractions will be performed by the same clinician using standard clinical procedures.

Participants' anxiety, pain, and vital signs will be checked before the procedure, after anesthesia, and after tooth extraction. Anxiety will be measured with the Face Image Scale (FIS). Pain will be measured with the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale (WBS). Vital signs will include systolic and diastolic blood pressure, heart rate, and oxygen saturation. No blood, saliva, or tissue samples will be collected, and no audio or video recording will be made.

Conditions

  • Tooth Extraction
  • Dental Anxiety
  • Procedural Pain
  • Anesthesia, Dental

Interventions

PROCEDURE

Conventional Syringe Injection

Local anesthesia will be administered to the mandibular buccal and lingual regions using a conventional syringe with a 27-gauge dental needle. Topical lidocaine spray will be applied before injection, and 4% articaine with 1:100,000 epinephrine will be used.

DEVICE

Needle-Free Jet Injection System

Local anesthesia will be administered to the mandibular buccal and lingual regions using a needle-free jet injection system. Topical lidocaine spray will be applied before injection, and 4% articaine with 1:100,000 epinephrine will be used.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Semih Ercan Akgün, DDS, PhD · Ondokuz Mayıs University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-10-01
Completion
2026-12-31

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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 NCT07548892 on ClinicalTrials.gov