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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pacific NW Dental Practice-Based Research Network
Information provided by (Responsible Party):
Greg Huang, University of Washington
ClinicalTrials.gov Identifier:
NCT01059058
First received: January 27, 2010
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Tooth Demineralization
Procedure: MI Paste Plus
Procedure: PreviDent Fluoride Varnish
Procedure: Normal Home Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of White Spot Lesions After Orthodontic Treatment: A Practice-based Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Improvement as rated by blinded assessors viewing photographs before and after treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate subjects' self-assessment of improvement against a group of blinded examiners for the amelioration of WSL. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Improvement as rated by blinded assessors viewing photographs in the period between the day of orthodontic appliance removal and retainer delivery. [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]
  • To investigate variables (age, gender, time since fixed orthodontic appliance removal, compliance, oral hygiene practices, etc) that may influence WSL regression and the effectiveness of the treatment and control groups. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test Group A: MI Paste Plus Group 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.
Other Name: CPP-ACP
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.
Other Name: Home care
Active Comparator: Test Group B: Fluoride Varnish Group 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.
Other Name: Fluoride varnish
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.
Other Name: Home care
Placebo Comparator: Control Group 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.
Other Name: Home care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completed fixed appliance orthodontic therapy within the past two years
  • Have at least one white spot lesion on the facial surface of a maxillary central or lateral incisor tooth that was not present prior to treatment with fixed orthodontic appliances.
  • Between the ages of 12 and 20 years of age
  • Agrees to randomization to the different treatment protocols
  • Signed informed consent obtained from a parent or guardian of the patient f the patient is under the age of eighteen

Exclusion Criteria:

  • Not willing to be randomly assigned to one of the three treatment groups
  • Any abnormal oral, medical, or mental conditions, including any milk-related allergies and/or any medical conditions involving the kidneys.
  • Any patients who underwent therapy for white spot lesion after completion of orthodontic treatment
  • Any white spot lesion present on qualifying teeth with frank cavitation
  • Patient is non-English speaking or non-English reading
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059058

Locations
United States, Washington
University of Washington/NW PRECEDENT
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Pacific NW Dental Practice-Based Research Network
Investigators
Principal Investigator: Greg H Huang, DMD,MSD,MPH University of Washington
  More Information

No publications provided

Responsible Party: Greg Huang, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01059058     History of Changes
Other Study ID Numbers: 37062-E/B
Study First Received: January 27, 2010
Last Updated: November 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
MI Paste Plus
Fluoride Varnish
CPP-ACP
White Spot Lesions
Remineralization
Orthodontic Treatment

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014