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Isolite and Dental Treatment Under Conscious Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683851
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Claudia Isabel Contreras, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date September 7, 2012
First Posted Date September 12, 2012
Last Update Posted Date December 13, 2013
Study Start Date August 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2013)
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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 12, 2013)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Isolite and Dental Treatment Under Conscious Sedation
Official Title Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pediatric patients in need of a sedation dental appointment
Condition Dental Caries
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2013)
20
Original Estimated Enrollment
 (submitted: September 11, 2012)
25
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 7 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01683851
Other Study ID Numbers HSC200120233H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Claudia Isabel Contreras, The University of Texas Health Science Center at San Antonio
Study Sponsor The University of Texas Health Science Center at San Antonio
Collaborators Not Provided
Investigators
Principal Investigator: Claudia I Contreras, DDS University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date December 2013