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Isolite and Dental Treatment Under Conscious Sedation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claudia Isabel Contreras, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01683851
First received: September 7, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.

Condition Intervention
Dental Caries
 Device: Isolite System

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Estimated Enrollment: 25
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Isolite
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pediatric patients in need of a sedation dental appointment

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683851

Locations
United States, Texas
University of Texas Health Science Center-Dental School
San Antonio, Texas, United States, 78229
University of Texas Health Science Center-Ricardo Salinas Dental Clinic
San Antonio, Texas, United States, 78237
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Claudia I Contreras, DDS University of Texas
  More Information

No publications provided

Responsible Party: Claudia Isabel Contreras, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01683851     History of Changes
Other Study ID Numbers: HSC200120233H
Study First Received: September 7, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
pediatric
conscious sedation
mouthpiece
airway
isolite system

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013