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Study of Treatments Used for White Spot Lesions After Orthodontic Treatment.

NCT01059058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-08-17

No results posted yet for this study

Summary

The purpose of this study is to learn more about the management of white spot lesions that occur after orthodontic treatment. White spot lesions generally improve slightly with time. To date, there is no proven method to help white spot lesions improve faster. Two treatments, called MI Paste Plus and fluoride varnish, have shown some potential benefits in a laboratory setting but have not undergone testing in a clinical setting. Approximately 240 subjects are to be enrolled in this study. The study will take place in approximately 30 dental and orthodontic offices across Idaho, Montana, Oregon, Utah, and Washington as part of Northwest PRECEDENT, a five-state research network that was created to study the practical issues facing dentists/orthodontists and their patients, and to provide information that will improve the quality of oral health care as a whole. Researchers at the University of Washington and Oregon Health \& Science University share management and oversight of the network and research projects.

Conditions

  • Tooth Demineralization

Interventions

PROCEDURE

MI Paste Plus

A trained staff member from the NW PRECEDENT dental/orthodontic office will give 3 tubes of MI Paste Plus (10% CPP-ACP + 900 ppm Fluoride paste) and instructions to the subject for home use. A pea-sized amount for each arch will be applied 2x/day for 8 weeks. Subjects will apply cream topically to the teeth with their finger or a cotton swab, spread around with their tongue, hold for 1-2 minutes, then expectorate.

PROCEDURE

PreviDent Fluoride Varnish

A trained staff member from the NW PRECEDENT dental/orthodontic office will provide a SINGLE application of PreviDent fluoride varnish (22,600 ppm Fluoride) to the subject. The total dosage will be 0.5 mL.

PROCEDURE

Normal Home Care

Subjects will receive non-prescription fluoride toothpaste (1100 ppm Fluoride) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate.

Sponsors & Collaborators

Principal Investigators

  • Greg H Huang, DMD,MSD,MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01059058 on ClinicalTrials.gov