CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
Isolite System +1 moredevice
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 6-16 years old at time of sealant placement
  • ✓ASA physical status I or II (healthy)
  • ✓Good cooperation (Frank score 3 or 4)
  • ✓Minimum 2 and maximum 16 matched contralateral permanent molars or premolars
Key exclusion· 5
  • ✕Teeth with history of past or current caries
  • ✕Teeth with clinical presentation of fluorosis, hypoplasia, or developmental anomalies
  • ✕Teeth with clinical or radiographic evidence of pathology
  • ✕Teeth with history of restoration or sealant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02668874
NCT02668874N/ACompleted
CompareCT.gov

A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants

University of Iowa·interventional·Posted Jan 29, 2016·Updated Feb 1, 2022

In Brief

A clinical study evaluating Isolite System and Cotton Roll Technique for Dental Caries on Pit and Fissure Surface. Completed, enrolled 104 participants across 1 site.

Detailed Summary

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries on Pit and Fissure Surface
CountriesUnited States
CollaboratorsDelta Dental of Iowa

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 29, 2016
Enrollment StartFeb 1, 2015
Primary CompletionAug 21, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.4 years ago

Interventions

Isolite Systemdevice

Cotton Roll Techniqueother