Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01683851 · ClinicalTrials.gov registry record
Isolite and Dental Treatment Under Conscious Sedation
A clinical trial of Dental Caries, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- 20
- Enrollment target
- 2
- Study locations
NCT01683851: Completed study of Dental Caries, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01683851 is a study of Dental Caries that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 20 participants, below the 721-participant average among 30 other Dental Caries trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683851, a study of Dental Caries, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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 I
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-06 |
What the finished NCT01683851 record still lists
NCT01683851 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 721-participant average among 30 other Dental Caries trials with a reported enrollment target (97% lower).
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.
NCT01683851 reports a single indexed study location in Texas.
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.
What interventions are being tested in trial NCT01683851?
The interventions under investigation include: Isolite System (DEVICE).
Who is sponsoring clinical trial NCT01683851?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Dental Caries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01683851's enrollment target sits among peer trials
20 28th of 30 higher than 2 of 30 other Dental Caries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dental Caries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
RECRUITING · NA
-
LT Comparative Effectiveness of 2 Caries Treatments
RECRUITING · NA
-
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
RECRUITING · NA
-
Oral Health Intervention in Adult Primary Care
RECRUITING · NA
-
Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
RECRUITING · NA
-
In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia