CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
OpalSeal +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03722264
NCT03722264N/ACompleted
CompareCT.gov

An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study

Virginia Commonwealth University·interventional·Posted Oct 26, 2018·Updated Mar 4, 2020

In Brief

A clinical study evaluating OpalSeal and TransbondXT for Cavities of Teeth. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Fluoride is very effective in preventing dental decay (cavities) when applied in the form of a varnish on tooth surfaces. The purpose of this study is to verify if fluoride-releasing primer (OpalSeal) offers more protection against early dental decay (cavity) compared to conventional primer (Transbond XT) during treatment with braces.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCavities of Teeth
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2018
Enrollment StartNov 16, 2017
Primary CompletionApr 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago

Interventions

OpalSealdevice

OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets

TransbondXTdevice

Transbond is a primer used to bond orthodontic brackets that does not contain fluoride