Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry (NCT07351383) | Clinical Trial Compass
CompletedPhase 3
Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry
Mexico28 participantsStarted 2025-06-15
Plain-language summary
This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.
Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.
Who can participate
Age range
6 Years – 12 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:
* Systemic health: No significant medical history or uncontrolled systemic disease.
* Bilateral dental pathology requiring treatment: At least two teeth (one per mandibular hemiarch) requiring bilateral inferior alveolar nerve blocks for restorative or endodontic treatment.
* Cooperation level: Frankl behavioral rating scale classification III or IV (positive or very positive).
* Informed consent/Child assent: Signed informed consent from parent or legal guardian; signed assent from participant (age-appropriate).
Exclusion Criteria:
* Acute dental emergency requiring immediate treatment.
* Known hypersensitivity or allergy to benzocaine or other local anesthetics.
* Known hypersensitivity to cold (cryophobia or cold urticaria).
* Significant dental anxiety or phobia precluding study participation.
* Developmental delay or behavioral disorders limiting communication or cooperation.
* Current use of medications affecting pain perception or hemodynamic parameters.
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 perception
Timeframe: Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa.