N/A
N=208
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Dental Caries on Pit and Fissure Surface
Bottom Line
View on ClinicalTrials.gov: NCT02668874 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Sealant Retention Percentage at 12 Months After Treatment — 59; 66 teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Isolite System (Device); Cotton Roll Technique (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sealant Retention Percentage at 12 Months After Treatment |
59; 66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy patients: American Society of Anesthesiologists (ASA) I or II
- Good cooperation: Frank1 3 or 4
- Aged between 6-16 years old at the day of sealant placement
- Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.
Exclusion Criteria
- Teeth with a history of past or current caries
- Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
- Teeth with clinical or radiographic evidence of pathology
- Teeth with a history of restoration or sealant
- Patients who are poorly behaved
Data sourced from ClinicalTrials.gov (NCT02668874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.