Isolite and Dental Treatment Under Conscious Sedation

Completed

• Conditions: Dental Caries

• Registration Number: NCT01683851
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
• 4-7 years of age
• Patients English and Spanish speaking

Exclusion Criteria

• Upper airway infection
• Craniofacial anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isolite and Dental Treatment Under Conscious Sedation	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).

Secondary Outcome Measures

Name	Time	Method
Isolite and Dental Treatment Under Conscious Sedation	120 minutes (sedation appointment)	Finally, it is important to recognize that this is a pilot study with limitations, including: 1. A small number of participants; 2. No group control; 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: 1. Isolite ® may be safely used during pediatric dental treatment under conscious sedation.; 2. The successful use of Isolite ® is related to the patient's behavior. The weakness aspect of Isolite ® is the soft bite block that allows the youngest patients to chew on it.; Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.

Trial Locations

Locations (2)

University of Texas Health Science Center-Ricardo Salinas Dental Clinic; 🇺🇸 San Antonio, Texas, United States

University of Texas Health Science Center-Dental School; 🇺🇸 San Antonio, Texas, United States