Isolite and Dental Treatment Under Conscious Sedation

December 12, 2013 updated by: Claudia Isabel Contreras, The University of Texas Health Science Center at San Antonio

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center-Dental School
      • San Antonio, Texas, United States, 78237
        • University of Texas Health Science Center-Ricardo Salinas Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients in need of a sedation dental appointment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isolite and Dental Treatment Under Conscious Sedation
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).
120 minutes (sedation appointment time)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isolite and Dental Treatment Under Conscious Sedation
Time Frame: 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.
120 minutes (sedation appointment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Claudia I Contreras, DDS, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC200120233H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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