Trial Outcomes & Findings for Orthodontic Varnish Microbiology Study (NCT NCT04528134)

Three subjects were enrolled in the study but did not move forward with participation in the study timepoints.

Not all participants completed the study and not all samples produced sufficient analyzeable data.

Assessed change in severity of white spots on the teeth as measured by the DiagnoDent, which uses quantitative light-induced fluorescence to assess the depth/severity of enamel demineralization. The DiagnoDent gives a score from 0-100, with 100 indicating the most demineralization (worse outcome) and 0 indicating the least demineralization (best outcome).

Assessed change in plaque levels, as measured by the Turesky-modified Quigley Hein Plaque Index. This index is measured on a scale of 0 to 5, with 5 representing the most plaque present (worst outcome) and 0 representing the least plaque present (best outcome). Below are the definitions of the scoring: 0: no plaque on the tooth 1. flecks of plaque along the gum margin 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth 3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth 4. plaque covering at least one-third but less than two thirds of the crown of the tooth 5. plaque covering two-thirds or more of the crown of the tooth

Colony forming units were measured on BHI (Brain Heart Infusion) plated samples from the different subject groups. BHI plating allows for culturing microorganisms in a nutrient-rich environment that serves as a versatile growth medium. A higher score indicates a higher presence of microorganisms (worse outcome), and a lower score indicates a lower presence of microorganisms (better outcome). There is no maximum score for CFUs, and a score of 0 would indicate a sterile sample where no microorganisms were detected.

Change in amounts of Streptococcus mutans, as measured by counting Colony-Forming Units (CFUs) after plating samples on a medium that is specifically targeted to cultivate Streptococcus microorganisms. A higher score indicates a higher presence of Streptococcus mutans (worse outcome), and a lower score indicates a lower presence of Streptococcus mutans (better outcome). There is no maximum score for CFUs, and a score of 0 would indicate a sample where no Streptococcus microorganisms were detected.

Assessed change in the visual appearance of white spots on the teeth, as measured by the ICDAS (International Caries Detection and Assessment System) from clinical photographs. The lowest score (0) indicates the best outcome, and the highest score (6) indicates the worst outcome. 0: Sound tooth surface, no evidence of decay 1. First visual change in enamel 2. Distinct visual change in enamel 3. Localized enamel breakdown, small cavitation or breakdown of the enamel without visible dentin showing 4. Underlying dark shadow from dentin, possible small breaks in enamel 5. Distinct cavity exposing underlying dentin involving less than half the tooth 6. Extensive distinct cavity exposing the dentin involving at least half of the tooth surface and potentially reaching the pulp