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Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement

NCT04538963 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-09-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene.

The investigators hypothesize that placing orthodontic bands with glass ionomer cement will arrest and possibly remineralize incipient carious lesions compared to teeth that are being monitored without intervention.

Conditions

  • Dental Caries Class II
  • Dental Caries in Children
  • Dental Caries on Smooth Surface Limited to Enamel

Interventions

DEVICE

Orthodontic Band affixed with Glass Ionomer Cement

Glass ionomer cement utilized to affix a blank orthodontic band to the tooth; the mechanical retention of the band will also help retain cement in contact with the tooth- the hypothesis is that the fluoride release from the cement will aid in remineralization of tooth structure.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Macaire C Thiel, DDS MS · Children's Hospital of Wisconsin, Pediatric Dental Residency Program Faculty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
209 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04538963 on ClinicalTrials.gov