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Recruiting NCT07108439

Usefulness of Intraosseous Anesthesia for Permanent Tooth Extraction Under GA in Pediatric Dental Treatment

Trial Parameters

Condition No Condition, Assessment of Healthy Volunteers
Sponsor University Hospital, Ghent
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 6 Years
Max Age 12 Years
Start Date 2025-08-14
Completion 2027-05-05
Interventions
Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia

Brief Summary

The investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. This sometimes causes children to bite themselves without realizing it, which can make them upset when they wake up. In this study, the investigators are testing a special technique called intra-osseous anesthesia, which numbs only the tooth and not the surrounding soft tissues. The investigators hope this will reduce pain after surgery without causing numbness or accidental biting. Children in the study will be randomly placed into one of two groups: one group will receive this special anesthesia before the tooth is removed, and the other group will not. Before and after the procedure, the investigators will ask some short questions and observe the participants to check for pain, anxiety, or confusion. The parents of the participants will also receive a short online questionnaire to fill out the day after the procedure. The goal is to find out if this method helps children wake up more comfortably, feel less pain, and avoid side effects. This could improve how dentists care for children during dental treatments in the future.

Eligibility Criteria

Inclusion Criteria: * \- Children between 6 and 12 years old, belonging to the category of ASA I or II according to the 'American Society of Anaesthesiologists' * Children who are cooperative enough for pre- and post-operative measurements * Children who are not allergic to components of local anaesthesia * Children who need at least one extraction of a FPM * Children without a hematological condition * Children who haven't taken painkillers 48 hours before the procedure * Patients who need a treatment under general anaesthesia (nasal intubation) due to polycaries/fear/anxiety. * Able to obtain a written consent from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes Exclusion Criteria: * \- Treatment with a laryngeal mask * If a traumatic extraction is needed, this patient is excluded from the study * Children who do not meet the inclusion criteria * Deviation in the pain relief protocol * Parents/child don't speak Dutch * Patien

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