Isolite and Dental Treatment Under Conscious Sedation

This study has been completed.
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: December 12, 2013
Last verified: December 2013
  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:


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

Primary Outcome Measures:
  • Isolite and Dental Treatment Under Conscious Sedation [ Time Frame: 120 minutes (sedation appointment time) ] [ Designated as safety issue: No ]

    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:
  • Isolite and Dental Treatment Under Conscious Sedation [ Time Frame: 120 minutes (sedation appointment) ] [ Designated as safety issue: No ]

    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.



Enrollment: 20
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

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: December 12, 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 October 19, 2014