NCT01683851

Isolite and Dental Treatment Under Conscious Sedation

Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

Summary

Hypothesis The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation. Purpose: Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation. Objectives: 1. Determine changes in pulse rate 2. Determine changes in SpO2 3. Recognize breath sound's changes possibly associated with airway blockage 4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation 5. Relate the use of Isolite® with the frequency of head reposition to open the airway.

Detailed description

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	Isolite System	A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-09-12
• Last updated: 2013-12-13

Locations

2 sites across 1 country: United States