N/A N=12 Randomized Double-blind Prevention

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

Cavities of Teeth

Bottom Line

View on ClinicalTrials.gov: NCT03722264 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Feb 2020

Primary outcome: Primary: Loss of Mineral Density in the Enamel — 70.8; 77.4 microns

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OpalSeal (Device); TransbondXT (Device)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Loss of Mineral Density in the Enamel	70.8; 77.4	—
SECONDARY Surface Topography and Hardness	—	—
SECONDARY Retention of OpalSeal	28.1	—

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.

Eligibility Criteria

Inclusion Criteria

Patients age 10 and older seeking treatment at the VCU Orthodontics Clinic who require extraction of at least 2 teeth for orthodontic purposes
Such teeth should be free of any developmental defects

Exclusion Criteria

Patients under 10 years of age
Patients with defective teeth
Those who cannot provide consent/assent OR not able to follow research protocols
Protected population (prisoners)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03722264). 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.