Dental Isolation Systems Among Pediatric Patients With Different Airway Patency
Launched by KING ABDULAZIZ UNIVERSITY · Nov 7, 2023
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how two different dental isolation systems—DryShield isolation (DSI) and Rubber Dam isolation (RDI)—affect children during dental procedures. Specifically, the study will measure things like how well children breathe, their heart rate, blood pressure, behavior, and any pain or discomfort they might feel while getting fissure sealants on their teeth. The trial will include healthy and cooperative children aged 6 to 12 who need this specific dental treatment. To participate, children must have fully erupted permanent first molars and will be grouped based on their airway openness, which will be assessed by two trained dentists.
Participants can expect to have their vital signs monitored throughout the procedure, which will also be recorded on video. Pain levels and behavior will be tracked using simple scales to help understand how they’re feeling during treatment. The study aims to gather valuable insights that could improve dental care for children, particularly those who may have challenges with breathing. Note that children with certain dental issues or previous uncooperative behavior will not be eligible to participate.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Healthy
- • 2. Cooperative
- • 3. 6-12-year-old children
- • 4. Who need fissure sealants in at least two contralateral fully erupted permanent first molar
- Exclusion Criteria:
- • 1. Children with partially erupted, previously restored, or carious first molars.
- • 2. Children with uncooperative behavior during their previous dental treatment.
- • 3. Children with fixed orthodontic appliances
- • 4. Children with nasal obstruction
About King Abdulaziz University
King Abdulaziz University (KAU) is a leading academic institution located in Jeddah, Saudi Arabia, renowned for its commitment to advancing medical research and innovation. As a prominent clinical trial sponsor, KAU leverages its extensive resources and expertise to facilitate groundbreaking studies aimed at improving healthcare outcomes. The university fosters collaboration among multidisciplinary teams of researchers, clinicians, and industry partners, ensuring adherence to rigorous ethical standards and regulatory requirements. KAU is dedicated to enhancing scientific knowledge and translating research findings into practical applications that benefit patients and the broader community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jeddah, , Saudi Arabia
Patients applied
Trial Officials
Sara M Bagher, Mater
Principal Investigator
Associate Professor
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported