Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07108439

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

Led by University Hospital, Ghent · Updated on 2025-10-03

80

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children between 6 and 12 years old, classified as ASA I or II by the American Society of Anaesthesiologists
  • Children who can cooperate for pre- and post-operative assessments
  • Children not allergic to local anesthesia components
  • Children needing at least one first permanent molar extraction
  • Children without any hematological conditions
  • Children who have not taken painkillers within 48 hours before the procedure
  • Children requiring dental treatment under general anesthesia with nasal intubation due to extensive cavities, fear, or anxiety
  • Written consent obtained from parent or guardian after full explanation of the procedure and outcomes
Not Eligible

You will not qualify if you...

  • Use of a laryngeal mask during anesthesia
  • Need for traumatic tooth extraction
  • Children not meeting inclusion criteria
  • Any deviation from the pain relief protocol
  • Parents or child do not speak Dutch
  • Missing data during procedure or follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

S

Sivaprakash Rajasekharan, BDS,MSc,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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