CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Isolite Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01683851
NCT01683851N/ACompleted
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Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population

The University of Texas Health Science Center at San Antonio·observational·Posted Sep 12, 2012·Updated Dec 13, 2013

In Brief

An observational study evaluating Isolite System for Dental Caries. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.8 years ago

Interventions

Isolite Systemdevice

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