MI Varnish for the Prevention of White Spot Lesions
Condition: White Spot Lesion; Orthodontic Treatment
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study aimed to determine if MI Varnish has an effect in preventing the formation
      of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were
      prospectively recruited for the project as the MI Varnish group, with a control group of 29
      orthodontically treated subjects who received routine treatment and oral hygiene
      regimes.Difference in prevention of white spot formation between the control and the study
      groups were evaluated through photographic records and clinical examination by using the
      Enamel Decalcification Index (EDI) scores.
    

Detailed description: 
      Orthodontists face 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. A new product, MI Varnish, is current
      available and has been shown in some initial case reports to be useful in reducing white spot
      lesions. It contains a special milk-derived protein RECALDENT TM (CPP-ACP) in which the
      casein phosphopeptides (CPP) bind to teeth, dentin, and oral mucosa while the amorphous
      calcium phosphate (ACP) releases calcium and phosphate. The current study aimed to determine
      if MI Varnish has an effect in preventing the formation of white spot lesions for patients
      undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as
      the MI Varnish group, with a control group of 29 orthodontically treated subjects who
      received routine treatment and oral hygiene regimes. The study group received the MI Varnish
      on the day of bracket bonding. Subjects were recalled initially for 4 weeks (twice) and then
      at 3 monthly intervals. Difference in prevention of white spot formation between the control
      and the study groups were evaluated through photographic records and clinical examination by
      using the Enamel Decalcification Index (EDI) scores.
    

Intervention name(s): MI Varnish; Control group
Intervention type(s): Drug; Other
Intervention description(s): MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.; Participants received routine treatment and oral hygiene regimes. No intervention for this group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Enamel decalcification