"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Chil… (NCT07056101) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Children Undergoing Molar Extraction
Egypt76 participantsStarted 2025-07-01
Plain-language summary
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.
Who can participate
Age range
6 Years – 8 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 from 6 to 8 years old
* Both sexes
* Healthy children classified as ASA I
* Children with maxillary primary molars indicated for extraction
* No previous dental experience
* Mentally capable of communication and following instructions
* No acute dental pain
Exclusion Criteria:
* Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
* Children with known allergies to the local anesthetic or dental materials used in the study
* Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
* Children whose parents or legal guardians refuse to sign the informed consent form
* Children experiencing acute dental pain
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
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
Timeframe: Immediately after local anesthesia injection