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Completed

NCT Number: NCT01683851

Isolite and Dental Treatment Under Conscious Sedation

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.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isolite System

Device

A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.

Other names: Isolite

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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:

    • A small number of participants
    • 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:

    • Isolite ® may be safely used during pediatric dental treatment under conscious sedation.
    • 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2012
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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