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

Starting soon · Not applicable

Conditions studied: Tooth Extraction, Dental Anxiety, Procedural Pain, Anesthesia, Dental

In brief

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.

Key facts

Study ID: NCT07548892
Run by: Ondokuz Mayıs University
People needed: 60
Starts: 2026-04-15
Expected to finish: 2026-12-31
Last updated by the study team: 2026-04-29

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
No known history of allergy to local anesthetics
No antibiotic use in the last month and no analgesic use in the last 12 hours
Not having acute dental pain
Having sufficient cognitive ability to understand the anxiety assessment scales
Voluntary participation with written parental consent

You may not qualify if…

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
Incomplete root development of the underlying permanent tooth
History of systemic disease (for example heart disease, uncontrolled asthma, epilepsy, diabetes)
Inability to use pain/anxiety scales due to neurological or developmental disorder
History of allergic reaction to local anesthetics or other drugs used
Presence of hypersensitivity to odors or inhalation intolerance
Refusal of participation by the child or parent

Full record on ClinicalTrials.gov

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