Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary
      ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm
      attachment to tooth surfaces thereby eliminating the possibility for the tooth to be
      demineralized. The hypothesis is that UDMA-K18 containing smooth surface sealant will be more
      effective at reducing enamel demineralization than the UDMA control or no treatment.
    

Detailed description: 
      Esthetics is a motivating factor to seek orthodontic treatment. However, if oral hygiene is
      inadequate during fixed appliance wear, unsightly white spot lesions (WSL) may develop. WSLs
      are areas of enamel demineralization that develop due to microbial assault that manifest as
      white, chalky opacity on the enamel. Urethane dimethacrylate (UDMA) can be modified to
      produce an antimicrobial compound, UDMA-K18, that has been proven to decrease microbial
      attachment in-vitro. (Sticker 2016) The use of a UDMA-K18 containing sealant may help to
      eliminate the development of WSLs around orthodontic brackets.

      This study will place experimental or control smooth surface resins on teeth that are
      scheduled to be extracted for orthodontic reasons. These teeth are typically bicuspids that
      are to be extracted to create room for the orthodontic movement of teeth. These teeth are
      usually not extracted at the advent of first orthodontic bracket bonding but are extracted
      about 30 days later. The design of this study is to place sealants on those teeth (or as
      control, no sealant) and evaluate the teeth after they have been extracted.

      Design: The study is a prospective, paired randomized control trial for which treatment (no
      sealant, UDMA-control, or UDMA-K18 sealant) will be applied clinically and evaluated on
      extracted teeth in laboratory conditions.

      Procedures: Before bonding, one premolar per patient will be assigned to a group. The group
      each premolar is assigned to will be determined by a randomized, computer generated program.
      The allocation will be concealed in an opaque envelope that will be opened at the time of
      initial bonding. If a fourth premolar is planned for extraction, a random selection of the
      treatments will be selected in a 1:1:1 ratio and this treatment will be applied to the fourth
      premolar.

      At the time of initial bonding, the UDMA and UDMA-K18 sealant will be applied to the selected
      premolar following manufacturer instructions. Briefly, the clinician will isolate the teeth
      using the NOLA Dry Field System and excess saliva will be removed by drying the teeth with an
      air-water syringe. In the treatment group, 37 % Phosphoric Acid will be applied to the entire
      buccal surface for 30 seconds, rinsed, and dried. Next, the assigned sealant will be evenly
      applied to the entire buccal surface of the premolar and light cured. The sealant which is
      adhesive will be applied to the bracket pad and the bracket pad will be pushed to place,
      excess cement will be removed and light cured.

      In the control group, 37 % Phosphoric Acid will be applied for 30 seconds strictly to the
      area where the bracket will be bonded on the buccal surface, rinsed, and dried. No sealant
      will be applied. The adhesive sealant will be applied to the bracket pad and the bracket pad
      will be pushed to place, excess cement will be removed and light cured. After 3-6 weeks, the
      patient will have their premolars extracted. After extraction they will be placed in a Tooth
      Storage Solution (25 % ethanol, 75 % water with the addition of saturated hydroxyapatite, 20
      mg of NaN3, and 40 mg Thymol) that is antimicrobial and does not alter the tooth surface.
      These teeth will be collected by the investigators for histologic study.

      The collected, extracted teeth will be sectioned using a water-cooled, Buhler slow speed
      diamond saw in three 2mm sections through the bracket base. A polarized light microscopy
      (PLM) digitized photograph of the cross-sectional sample will be analyzed to determine the
      depth of lesions, if present. The mineral density profile will be analyzed using contact
      micro radiography (TMR).
    

Intervention name(s): UDMA-K18 smooth surface sealant
Intervention type(s): Device
Intervention description(s): The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
Other intervention name(s): UDMA-control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, paired randomized control trial for which treatment (no sealant, UDMA control, UDMA-K18 sealant) will be applied clinically and evaluated on extracted teeth in laboratory conditions.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental caries; white spot lesion; prevention; smooth surface sealant