Isolite System
DeviceA type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
Other names: Isolite
NCT Number: NCT01683851
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.
Looking for future studies?
Notify Me4 year–7 year
All sexes
Observational
University of Texas Health Science Center-Dental School, San Antonio, Texas, United States
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
Other names: Isolite
Time frame: 120 minutes (sedation appointment time)
In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam.
Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).
Time frame: 120 minutes (sedation appointment)
Finally, it is important to recognize that this is a pilot study with limitations, including:
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.
Conclusions:
The results of this pilot study suggest the following conclusions:
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.
The University of Texas Health Science Center at San Antonio
Other
Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population
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