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

Recruiting now · Not applicable

Conditions studied: No Condition, Assessment of Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT07108439
Run by: University Hospital, Ghent
People needed: 80
Starts: 2025-08-14
Expected to finish: 2027-05-06
Last updated by the study team: 2025-10-03

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

- 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

You may not qualify if…

- 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
Patients with missing data during the procedure/follow-up

Where it is running

Ghent University Hospital — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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