Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth (NCT03878173) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth
France125 participantsStarted 2016-04-01
Plain-language summary
This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.
Who can participate
Age range
2 Years – 15 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 in range of 2-15 years indicated for tooth extractions under local anesthesia.
Exclusion Criteria:
* patient under analgesic the day of the appointment or under non steroidal anti-inflammatory agents through 8 days before the extraction;
* contraindication to paracetamol/acetaminophen;
* incomplete mental health;
* extraction under sedation (including nitrous oxide/oxygen) and under general anesthesia.
* extractions of permanent tooth;
Child was also excluded from the study if parents could not be reached by phone within 32 hours after extraction and if the parents don't speak French.
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
prevalence and severity of pain after extraction of deciduous teeth