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New treatment option for No Condition, Assessment of Healthy Volunteers
Official title Usefulness of Intraosseous Anesthesia for Permanent Tooth Extraction Under GA in Pediatric Dental Treatment
ClinicalTrials.gov ID: NCT07108439
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- \- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.