Study of Treatments Used for White Spot Lesions After Orthodontic Treatment.
Treatment of White Spot Lesions After Orthodontic Treatment: A Practice-based Randomized Controlled Trial
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 17, 2015
August 1, 2015
1.8 years
January 27, 2010
August 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement as rated by blinded assessors viewing photographs before and after treatment.
8 weeks
Secondary Outcomes (3)
To investigate subjects' self-assessment of improvement against a group of blinded examiners for the amelioration of WSL.
8 weeks
Improvement as rated by blinded assessors viewing photographs in the period between the day of orthodontic appliance removal and retainer delivery.
2-7 days
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.
8 weeks
Study Arms (3)
Test Group A: MI Paste Plus Group
ACTIVE COMPARATORTest Group B: Fluoride Varnish Group
ACTIVE COMPARATORControl Group
PLACEBO COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington/NW PRECEDENT
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg H Huang, DMD,MSD,MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 27, 2010
First Posted
January 29, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2011
Study Completion
July 1, 2012
Last Updated
August 17, 2015
Record last verified: 2015-08