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Clinical trial Recruiting at 1 site Interventional Ages 6 to 12

Intra‑osseous anesthesia for removing a permanent molar in children under general anesthesia

Official title: The Effectiveness of Intra-osseous Anaesthesia in Reducing Immediate and Delayed Post-operative Complications Associated With the Extraction of First Permanent Molars Under General Anaesthesia: A Randomised Controlled Trial

Run by University Hospital, Ghent · NCT07108439 · Data updated 2026-11-12

We'll test whether intra‑osseous (tooth‑only) anesthesia given to children aged 6–12 having a permanent molar removed under general anesthesia reduces postoperative pain, numbness, and accidental lip or cheek biting.

Quick facts

Study typeInterventional
Ages6 Years to 12 Years
SexAll
Enrollment80 (estimated)
SponsorUniversity Hospital, Ghent
Academic / other
Locations1 site (Ghent)
StatusRecruiting
StartedAugust 14, 2025
Main results expectedMay 5, 2027
Study endsMay 6, 2027
Registry record updatedOctober 3, 2025
Trial IDNCT07108439 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 6–12 with ASA I–II who need extraction of at least one first permanent molar under general anesthesia, are cooperative for pre‑ and post‑operative measurements, have no allergy to local anesthetics or hematologic disorders, and whose parent/guardian can provide written informed consent.

Probably not a fit

Children who require a traumatic extraction, use a laryngeal mask instead of nasal intubation, have allergies to local anesthetics, hematologic conditions, or whose family does not speak Dutch are unlikely to be eligible or to receive benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized interventional study at Ghent University Hospital comparing intra‑osseous local anesthesia (Quicksleeper 5) given just before extraction with no intra‑osseous anesthesia in children undergoing removal of a first permanent molar under general anesthesia. The operator performs limited mucosal anaesthesia, bone perforation, and injection into the bone so the tooth — not surrounding soft tissues — is numbed. Children are randomly assigned to one of the two groups and assessed with short questions and observations before and after the procedure for pain, anxiety, and immediate and delayed postoperative delirium. Extractions are performed at the end of the dental treatment under nasal intubation and patients are followed for early postoperative outcomes.

Why it matters

Potential benefit: If successful, the technique could reduce postoperative pain and soft‑tissue numbness, lower the risk of accidental lip or cheek biting, and decrease the need for painkillers in children.

How similar studies have gone: Intra‑osseous anesthesia has been used in dentistry and can provide tooth‑focused numbness with less soft‑tissue anesthesia, but randomized pediatric data specifically for extractions under general anesthesia are limited.

Who can join: the full rules

Show full inclusion / exclusion 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
* Patients with missing data during the procedure/follow-up

Where it's running

  • Ghent University Hospital
    Ghent, Belgium     Recruiting

Study contacts

  • Principal investigator: Chloë Sterkens — Equal Lifelong Oral Health for All Research Group, Paediatric Dentistry
  • Study coordinator: Sivaprakash Rajasekharan, BDS,MSc,PhD
  • Email: siva.rajasekharan@uzgent.be
  • Phone: +3293324008

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.