MedTrace Logo

Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions in Fixed Appliance Orthodontia

NCT03711097 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-09-03

No results posted yet for this study

Summary

This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.

Conditions

  • White Spot Lesion

Interventions

DRUG

Vanish XT Dental Varnish

Varnish will be applied to the front surface of the intervention upper central and lateral incisors

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Brad Herman, DDS · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2019-04-22
Completion
2019-04-22
FDA Drug
Yes

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 NCT03711097 on ClinicalTrials.gov