Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia
Launched by DICLE UNIVERSITY ·
Trial Information
Current as of November 12, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This study is comparing two ways to give local anesthesia for children during dental procedures: a computer-controlled system (SleeperOne 5) versus traditional syringe injections. It is a randomized, single-center trial using a split-mouth, within-child design, meaning each child will receive both methods—one on one side of the mouth and the other on the opposite side—for similar tooth procedures. About 84 healthy children aged 7 to 10 are planned to enroll. Key eligibility includes being generally healthy (no major health problems), cooperative for dental treatment, having not had prior dental treatment, and needing pulpotomy or pulpectomy in molars on both sides. Specific dental criteria ensure comparable tooth conditions between sides.
During the study, all participants will have standard steps before anesthesia (vital signs checked, drying the area, and topical numbing). Each technique uses the same local anesthetic and dose, but the method of delivery differs. Researchers will measure pain and anxiety before, during, and after anesthesia using several scales, and will monitor heart rate, oxygen level, and temperature. The trial is not recruiting yet, with an estimated start in October 2025 and a projected completion around March 2026. Results will be shared later, and de-identified data may be available to researchers who meet certain criteria.
Gender
ALL
Eligibility criteria
About Dicle University
Dicle University is a prominent academic institution located in the southeastern region of Turkey, dedicated to advancing medical research and education. With a strong commitment to improving healthcare outcomes, Dicle University actively sponsors clinical trials that aim to explore innovative treatments and enhance patient care. The university's multidisciplinary approach fosters collaboration among researchers, healthcare professionals, and students, ensuring that clinical studies are conducted with rigor and integrity. Through its clinical trial initiatives, Dicle University strives to contribute valuable insights to the scientific community and support the development of effective therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Emin C Tümen
Study Director
Dicle Universty
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported