Isolite and Dental Treatment Under Conscious Sedation

Study Overview
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Brief Summary
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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: Determine changes in pulse rate Determine changes in SpO2 Recognize breath sound's changes possibly associated with airway blockage Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation Relate the use of Isolite® with the frequency of head reposition to open the airway.

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

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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Isolite System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, conscious sedation, mouthpiece, airway, isolite system