Evaluating a new anesthesia method for children's dental procedures
Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)
This study is testing a new way to numb kids' mouths during dental work to see if it helps reduce pain and anxiety for children aged 5 to 9.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 5 Years to 9 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria, Alexandroa) |
| Trial ID | NCT06245161 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of computer-controlled intraosseous anesthesia using QuickSleeper5 in managing pain during dental treatments in pediatric patients aged 5 to 9 years. It will involve 120 healthy children who require either restorative treatment or extraction of primary molars. Participants will be randomly assigned to receive either the new intraosseous anesthesia or conventional anesthesia techniques, with pain responses measured through various scales and physiological parameters. The study will also evaluate child behavior and anxiety during dental procedures.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 5 to 9 years who require dental treatment involving local anesthesia.
Not a fit: Patients with physical or mental disabilities, immunocompromised conditions, or those with a history of adverse reactions to local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management in pediatric dental patients, leading to a more positive treatment experience.
How similar studies have performed: While there is ongoing research in dental anesthesia, this specific approach using computer-controlled intraosseous anesthesia is relatively novel and has not been extensively tested in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cooperative children during preoperative assessments. * Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination. * Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction. Exclusion Criteria: * Any physical or mental disability, or psychological problems. * Immunocompromised patients. * Hypersensitivity to local anesthetic drugs used * History of previous dental local anesthesia. * Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative
Where this trial is running
Alexandria, Alexandroa
- Alexandria University- Faculty of Dentistry — Alexandria, Alexandroa, Egypt (Recruiting)
Study contacts
- Principal investigator: sara quritum — Alexandria Univeristy
- Study coordinator: sara Quritum, PhD
- Email: sara.quritum@alexu.edu.eg
- Phone: +201020019396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.