Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience (NCT07106138) | Clinical Trial Compass
CompletedNot Applicable
Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience
Syria112 participantsStarted 2024-04-23
Plain-language summary
compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe, computer-controlled local anesthetic delivery system (Star Pen), needle-free injector (Comfort-In), or a vibrotactile device (Vibraject). Pain was assessed using the FLACC and Wong-Baker FACES scales, anxiety with the Venham Picture Test, and behavior with the Houpt scale. Vital signs including pulse and oxygen saturation were recorded during treatment. Additionally, satisfaction levels of both the patients and their parents were evaluated using structured questionnaires and Likert scales. The study seeks to determine which technique provides the most comfortable and effective experience for children undergoing dental procedures.
Who can participate
Age range
6 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children aged 6-10 years.
. Physically healthy with no neurological disorders or systemic diseases.
. Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
. Not taking any sedatives or analgesics drugs
Exclusion criteria
. Uncooperative children who exhibit clear behavioral problems.
. Children with systemic diseases or disorders that may interfere with local anesthesia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain level during dental anesthesia and treatment (behavioral assessment)
Timeframe: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
2
Pain level during dental anesthesia and treatment (self-reported)
Timeframe: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
3
Anxiety level during dental anesthesia and treatment
Timeframe: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.