Study of Treatments Used for White Spot Lesions After Orthodontic Treatment.
Condition: Tooth Demineralization
MeSH terms: Tooth Demineralization
Study type: Interventional

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.
    

Detailed description: 
      White spot lesions (WSL), caused by the decalcification of enamel, are a common and
      unfortunate sequela of orthodontic treatment. If not addressed, WSL may progress to caries
      and frank cavitation of the enamel surface. Once formed, white spot lesions compromise
      esthetics and can be extremely difficult or even impossible to reverse. Many clinicians
      consider a high-dose fluoride application to be the first step in treatment of WSL in order
      to arrest areas of decalcification. However, some believe that while remineralization with
      high levels of fluoride may repair the surface of enamel, it may possibly block
      remineralization of the deeper areas of enamel. This, in turn, may hamper efforts to
      normalize the appearance of WSL.

      Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) containing products are a
      recently proposed therapy for the treatment of white spots following orthodontic treatment.
      CPP is thought to stabilize and localize calcium, fluoride, and phosphate at the tooth
      surface in a slow-release amorphous form, thus enhancing deeper remineralization of WSL.
      Products containing CPP-ACP are currently marketed under various names, including MI Paste
      Plus (which also contains fluoride). Few in vivo studies have investigated the effectiveness
      of various remineralization products to address WSL after orthodontics. This project is a
      single-blind, randomized clinical trial with three arms - MI Paste Plus for an 8-week
      duration, a single application of Duraphat Fluoride Varnish with reassessment at 8 weeks, and
      normal home care for an 8 week period. Subjects will be recruited at their regularly
      scheduled orthodontic appointments, with eligible subjects being up to 2 years post-removal
      of fixed orthodontic appliances.

      This project is intended to answer four questions regarding the management of white spot
      lesions.

      Specific Aim 1: to compare the effectiveness MI Paste Plus and Duraphat Fluoride Varnish to a
      standard oral hygiene/toothpaste regimen in improving the appearance of WSL after orthodontic
      treatment.

      Specific Aim 2: to investigate subjects' self-assessment of improvement in each of the three
      arms.

      Specific Aim 3: to investigate variables (such as age, gender, time since fixed orthodontic
      appliance removal, compliance, oral hygiene practices, etc) that may influence WSL
      improvement.

      Specific Aim 4: to investigate the short-term changes in WSL from the day of orthodontic
      appliance removal until the day of retainer delivery (usually 2 - 7 days).

      This study will provide valuable evidence on the management of WSL after orthodontic
      treatment. As previously stated, WSL lesions are quite common and difficult to reverse, so it
      is important to conduct rigorous clinical research in an effort to develop effective
      strategies.

      This study will be a randomized clinical trial. NW PRECEDENT providers will invite subjects
      to participate if they are between the ages of 12 and 20 and have at least one new WSL on the
      4 maxillary incisors associated with orthodontic treatment. These are the most common teeth
      to develop these lesions. The NW PRECEDENT provider must verify that the WSL were not present
      in the pre-orthodontic treatment records. Subjects must be willing to be placed into any of
      the following three groups:

        1. Test Group A: 10% CPP-ACP + 900 ppm Fluoride paste - a trained staff member from the NW
           PRECEDENT dental/orthodontic office will give 3 tubes of MI Paste Plus and instructions
           to the subject for home use. The subjects will also receive non-prescription fluoride
           toothpaste (1100 ppm Fluoride) and oral hygiene instructions. The group will consist of
           80 subjects, and each subject will be given enough MI Paste for the duration of the
           trial. Treatment will begin on the day of retainer delivery if the subject was recruited
           on the day of fixed appliance removal. Otherwise, the treatment will begin on the date
           of recruitment.

        2. Test Group B: Fluoride Varnish Group - a trained staff member from the NW PRECEDENT
           dental/orthodontic office will provide a single fluoride varnish application (22,600 ppm
           Fluoride) to the subject. The subjects will also receive non-prescription fluoride
           toothpaste (1100 ppm Fluoride) and oral hygiene instructions. The group will consist of
           80 subjects. Treatment will begin on the day of retainer delivery if the subject was
           recruited on the day of fixed appliance removal. Otherwise, the treatment will begin on
           the date of recruitment.

        3. Control Group - These 80 subjects will receive non-prescription fluoride toothpaste
           (1100 ppm Fluoride) and oral hygiene instructions at the time of enrollment. After the
           trial is completed (~ August 2011), these subjects will be informed of the results, and
           offered one of the two active arms, if they are found to be effective in reducing WSL.

      The NW PRECEDENT provider and the subject will also fill out a short survey to compile
      information about the subject's age, gender, race, ethnicity, time in fixed appliances, oral
      hygiene during treatment, and type of retainers after orthodontic treatment. Upon determining
      a subject's eligibility and willingness to participate, as well as obtaining assent/consent,
      he/she will be randomly assigned to a group, a baseline photograph will be taken, and the
      assigned treatment will begin. In the case of subjects who have just had their orthodontic
      appliances removed, the subjects will undergo enrollment and photos, but their assigned
      treatment will not begin until the day of retainer delivery. The subject's general dentist
      (if they did not perform their orthodontic care) will be sent a letter informing them that
      their patients are currently enrolled in the study, and that any additional treatment for
      white spot lesions should be delayed until the study is complete (8 weeks).

      Subjects who are identified at some time after their fixed orthodontic appliances have been
      removed will have baseline photographs taken on the day of recruitment. Subjects who are
      identified on the day their appliances are removed will have photographs taken on that day,
      as well at the time of retainer delivery (2 - 7 days later). A subsequent analysis of the day
      of fixed appliance removal and one week follow-up photographs will be performed, in order to
      determine if significant changes are evident during this short period immediately after fixed
      appliance removal. This is being investigated because portions of the teeth under the braces
      have been shielded from the oral cavity for several years, and they may also have been
      desiccated during the removal of braces. Additionally, the gums may be puffy and swollen
      immediately after taking braces off, and parts of the teeth may not be visible. The
      photographs will be sent to the online data capture system.

      At the eight-week time point, NW PRECEDENT providers will recall the subjects (240 total) and
      take the eight-week follow-up photographs in the same standardized format as the baseline
      photographs. The photographs will be sent via the online data capture system. The NW
      PRECEDENT provider will administer an in office survey to the subject to gather information
      regarding satisfaction with using the treatment, compliance, oral hygiene practices, and
      self-assessment of improvement of the WSL.

      A group of blinded examiners consisting of five to ten laypersons and five to ten dental
      experts will view each subject's set of digital photographs in chronological order on a
      PowerPoint presentation. The photographs will only show the four maxillary incisor teeth and
      will be unidentifiable to the examiners. Each set of photographs will then be given an
      improvement rating on a 100 mm visual analog scale (VAS) (0=no improvement, 100=100%
      improvement). In addition, both a graduate orthodontic resident and a dental student will
      blindly assess the digital photographs by measuring the size of the white spot lesion
      relative to the rest of the tooth expressed as a percent. Statistical analysis will then be
      performed.
    

Intervention name(s): MI Paste Plus; PreviDent Fluoride Varnish; Normal Home Care
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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.
Other intervention name(s): CPP-ACP; Fluoride varnish; Home care
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: MI Paste Plus; Fluoride Varnish; CPP-ACP; White Spot Lesions; Remineralization; Orthodontic Treatment