Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Ve… (NCT07101068) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
Egypt40 participantsStarted 2024-01-25
Plain-language summary
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in 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:
* normal healthy patients (ASA I)
* Undergoing the first dental local anesthesia experience
* Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
* Score 3 or 4 of Frankl scale of child behavior
Exclusion Criteria:
* Presence of gingivitis, dental abscess, facial trauma/ injury
* Administration of analgesic 48 h before randomization
* Presence of allergy from 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 during injection
Timeframe: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.
2
Anxiety felt by the patient
Timeframe: the scale will be used at day 1 of anesthesia injection