Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions
Condition: White Spot Lesion; Orthodontic Treatment; Decalcification; Teeth
Study type: Interventional

Summary: 
      The purpose of the study is to determine if Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste
      Plus has an effect on the formation and resolution of white spot lesions for patients
      undergoing orthodontic treatment. This study will include 90 patients in the UAB Orthodontic
      Clinic.
    

Detailed description: 
      During the course of orthodontic treatment, the practitioner normally faces two common
      iatrogenic treatment side effects: root resorption and enamel decalcification, with the
      latter occurring at a much higher frequency. While the processes that lead to enamel
      demineralization are understood, methods to diminish or perhaps eliminate degradation of
      enamel surfaces are being searched for. Several approaches have been formulated to counteract
      demineralization of tooth structure. One approach involves patient compliance and consists of
      in-depth oral hygiene instructions, in-office fluoride applications, and at-home fluoride
      rinses, gels, and varnishes. An alternative approach, which possesses potential benefit
      regardless of patient compliance, includes the use of fluoride-releasing agents, such as
      composites, glass ionomers, sealants, and elastomeric ties.

      Enamel decalcification or white spot formation, is a phenomenon occurring primarily on smooth
      enamel surfaces of teeth, notably within the gingival third of the crown. Demineralized
      enamel, the precursor to caries formation, can be attributed to fixed orthodontic appliances,
      and prolonged exposure to bacterial plaque. Bacterial plaque promotes the accumulation of
      acidic byproducts and demineralization that leads to successive changes in the optical
      properties of subsurface demineralized enamel. Progression to clinically detectable white
      spot lesions may occur as early as one month following the placement of orthodontic
      appliances.

      Two new anti-cavity toothpastes, Clinpro™ 5000 with 1.1% Sodium Fluoride and Clinpro™ Tooth
      Crème with 0.21% Sodium Fluoride, are currently available and have been shown in some initial
      case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals
      and helps you produce saliva. Both the Clinpro™ products are advanced formulas containing an
      innovative tri-calcium phosphate ingredient. They are available exclusively from 3M ESPE.
      Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally
      found in saliva.

      Thus, this study will compare Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste,
      Clinpro™ Tooth Crème, and MI-Paste Plus for the prevention and reduction of white spot
      lesions during orthodontic treatment.
    

Intervention name(s): Clinpro™ 5000; Clinpro™ Tooth Crème; MI-Paste Plus
Intervention type(s): Other; Other; Other
Intervention description(s): Clinpro™ 5000 with 1.1% Sodium Fluoride is a new anti-cavity toothpaste, and is currently available and have been shown in some initial case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals and helps you produce saliva. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.; Clinpro™ Tooth Crème with 0.21% Sodium Fluoride is a new anti-cavity toothpaste, and is currently available and have been shown in some initial case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals and helps you produce saliva. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.; MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.
Other intervention name(s): Toothpaste produced by 3M ESPE.; Toothpaste produced by 3M ESPE.; Toothpaste produced by GC America
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups of 30 subjects (one group with Clinpro™ 5000, one group with MI-Paste Plus, and one group with Clinpro™ Tooth Crème) each will be evaluated as a protocol for the reduction of white spot lesions at the start of orthodontic treatment. Subjects will be recruited through the Orthodontic Postgraduate Clinic at the University of Alabama at Birmingham School of Dentistry.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: toothpaste