MedTrace Logo

An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients

NCT03722264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-03-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Cavities of Teeth

Interventions

DEVICE

OpalSeal

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

DEVICE

TransbondXT

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

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Parthasarathy Madurantakam, DDS · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-04-12
Completion
2019-04-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722264 on ClinicalTrials.gov