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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

Qualifiers

Being between 6-12 years of age

Having a primary tooth to be extracted with buccal and lingual anesthesia

Being in category 2, 3, or 4 according to the Frankl Behavior Scale

Being systemically healthy

Disqualifiers

Being under 6 years of age or over 12 years of age

Displaying category 1 behavior according to the Frankl scale

Presence of severe acute dental infection or a condition requiring emergency intervention

Presence of a requirement for surgical extraction in the tooth indicated for extraction

Trial design

Treatments tested in this trial

  • Needle-Free Jet Injection System
  • Conventional Syringe Injection

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators