About this trial
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.
Eligibility criteria
Qualifiers
Children aged from 6 to 8 years old
Both sexes
Healthy children classified as ASA I
Children with maxillary primary molars indicated for extraction
Disqualifiers
Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
Children with known allergies to the local anesthetic or dental materials used in the study
Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
Children whose parents or legal guardians refuse to sign the informed consent form
Trial design
Treatments tested in this trial
- A conventional dental syringe
- GENI High-Speed Injection
- GENI Moderate-Speed Injection
- GENI Low-Speed Injection
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Tarek MHD kher al saka amini
Lead sponsor
Cairo University
Sponsor institution