Dental Caries Clinical Trial
Official title:
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
The objective of this clinical study is to evaluate the efficacy of multiple applications of
MI Varnish in combination with MI Paste Plus in caries protection and remineralization in
comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse
recommendation) in orthodontic patients in a randomized, single blind, prospective,
controlled clinical trial over 12 months.
The effect will be measured by white spot lesion regression and prevention as lesion count.
Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme
(primary outcome), International Caries Detection and Assessment System (ICDAS), the caries
lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and
Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE
fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior
teeth with orthodontic brackets in treatment and control groups.
The study is designed as randomized, single blind, prospective, clinical trial over 12
months. The subjects for this study will be recruited from the University of California at
San Francisco UCSF, School of Dentistry, Orthodontic Clinic.
Participants in the study will be patients, who are in orthodontic treatment or will start
orthodontic treatment; subjects must have full fixed appliances, with brackets bonded to the
buccal surfaces of the maxillary and mandibular incisors, canines and first bicuspids.
Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP
(Adenosine triphosphate) bacteria testing. Subjects will present with at least two active
white spot lesions on his/her anterior teeth at the start of the study. The age limitation is
≥ 11 years.
The subjects will be randomly assigned to 1) Experimental group: MI Varnish and MI Paste Plus
or 2) Control standard of care group: 1,100 ppm Fluoride tooth paste and recommendation to
use OTC (Over-the-counter) Fluoride-rinse in the evening at home.
The clinical study investigator will evaluate the labial/buccal surfaces of upper and lower
anterior teeth (first bicuspid to first bicuspid) for white spot lesions (WSL) at baseline
and at the end of 3, 6, and 12 months. Newly formed lesions and changes in existing white
spot lesions will be documented (using Enamel Decalcification Index (EDI), ICDAS II, light
digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light
Fluorescence).
All subjects will receive one professional tooth cleaning at baseline and at each other
evaluation office visit to allow WSL evaluation (cleaning with ultrasonic device, and
prophylaxis brush) and treatment application.
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