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Search / Trial NCT07156487

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

Pediatric Dentistry Injections, Intraosseous Dental Instruments

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.

Locations

Patients applied

0 patients applied

Trial Officials

Emin C Tümen

Study Director

Dicle Universty

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported