Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite
Condition: White Spot Lesion
Study type: Interventional
Phase: Phase 1

Summary: 
      Dental caries is a common oral disease. The process of caries formation is a cycle of
      remineralization and demineralization with various stages being either reversible or
      irreversible.
    

Detailed description: 
      White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization,
      without cavitation. These manifestations represent the first clinical observation of the
      progression of dental caries, with the possibility of being reversed.

      WSLs are characterized by a white, chalky, opaque appearance and are commonly located in
      pits, fissures, and smooth surfaces of teeth. However, after the placement of fixed
      orthodontic appliances, there are an increasing number of plaque retention sites due to the
      presence of brackets, bands, wires and other applications, which make oral hygiene more
      difficult, and limit naturally occurring self-cleansing mechanisms. As a consequence, there
      is an increased risk of demineralization and, conclusively, of WSLs forming on smooth
      surfaces, if there is no effective plaque removal

      The clinical characteristics of these lesions include loss of normal translucency of the
      enamel because of altered light properties with a chalky white appearance, particularly when
      dehydrated; a fragile surface layer susceptible to damage from probing, particularly in pits
      and fissures; increased porosity, particularly of the subsurface, with increased potential
      for uptake of stains; reduced density of the subsurface, which may be detectable
      radiographically, with transillumination or with modern laser detecting devices; and
      potential for remineralization, with an increased resistance to further acid challenge
      particularly with the use of enhanced remineralization treatments.

      It is possible to find numerous therapies for WSLs, for instance, hygiene education,
      fluorides, phosphopeptide compounds, xylitol and infiltrative resins, microabrasion and/or
      bleaching, and preparation and restoration. The professional application or prescription of
      fluorides for home use includes: gels, toothpastes, mouthwashes and varnishes. The fluoride
      ions are revealed in three ways: sodium monofluorophosphate, sodium fluoride and amine
      fluoride. It has been found that high fluoride concentrations promote WSL remineralization
      However; it occurs in the enamel surface and inhibits the ions' movement through the
      subsurface, affecting the subsurface remineralization and therefore, the light reflection
    

Intervention name(s): Poly(Amidoamine) dendrimer
Intervention type(s): Drug
Intervention description(s): to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer, Nanohydroxy apatite & Their Combination on demineralized enamel & Their Clinical Efficacy on White Spot lesion
Other intervention name(s): Nano-hydroxyapatite
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment