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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Needle-Free Jet Injection System
DeviceLocal 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.
Conventional Syringe Injection
Procedure/SurgeryLocal 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Needle-Free Jet InjectionExperimental treatment 1 intervention
Group B: Conventional SyringeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety level measured by Face Image Scale
Anxiety will be assessed using the Face Image Scale (FIS), a 5-face visual anxiety scale with scores ranging from 1 to 5. Higher scores indicate greater anxiety (worse outcome).
Time frame
Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.2
Pain level measured by Wong-Baker Faces Pain Rating Scale (WBS)
Self-reported pain will be assessed using the Wong-Baker Faces Pain Rating Scale, a 6-face scale with scores ranging from 0 to 10. Higher scores indicate greater pain (worse outcome).
Time frame
Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.3
Pain level measured by Face, Legs, Activity, Cry, Consolability (FLACC) scale
Observed pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, with total scores ranging from 0 to 10. Higher scores indicate greater pain or distress (worse outcome).
Time frame
Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.Secondary outcomes
1
Diastolic blood pressure
Diastolic blood pressure, measured in mmHg with a digital pediatric blood pressure monitor, will be recorded to assess physiologic response.
Time frame
Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.2
Systolic blood pressure
Systolic blood pressure, measured in mmHg with a digital pediatric blood pressure monitor, will be recorded to assess physiologic response.
Time frame
Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.3
Heart rate
Heart rate, measured in beats per minute, will be recorded to assess physiologic response.
Time frame
Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.4
Oxygen saturation
Oxygen saturation, measured as peripheral oxygen saturation (SpO2, %), will be recorded to assess physiologic response.
Time frame
Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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