Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED

Isolite and Dental Treatment Under Conscious Sedation

NCT01683851 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE Isolite System

Study Locations (2)

Texas

  • University of Texas Health Science Center-Dental School — San Antonio
  • University of Texas Health Science Center-Ricardo Salinas Dental Clinic — San Antonio

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-08
Est. Completion 2013-06

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01683851

The ClinicalTrials.gov registry entry for NCT01683851 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 481 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 1 intervention — of which Isolite System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01683851 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01683851 about?

NCT01683851 is a clinical study titled "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 consci...

What is the current status of trial NCT01683851?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-08. Estimated completion is 2013-06.

What conditions does trial NCT01683851 study?

This clinical trial studies the following conditions: Dental Caries. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01683851?

The interventions under investigation include: Isolite System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01683851?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 481 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01683851 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial