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.

Eligibility Criteria:
Inclusion Criteria:

* age 11 or older,
* good health,
* either gender
* present with at least two active white spot lesions on his/her anterior teeth at the start of the study
* have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules
* require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study
* able to cooperate for treatment in the dental chair and follow at-home instructions
* have an understanding of the study
* willing to comply with all study procedures and protocols
* patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English
* patient participant or if a minor, the parent/guardian, is willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
* verifiable records of bonding with Transbond Plus Self-Etching Primer (3M Unitek, Monrovia, CA) and Transbond Light Cure Adhesive or similar products
* verifiable records that "ProSeal" has not been applied at any time during the orthodontic treatment

Exclusion Criteria:

* untreated cavitated lesions
* extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids
* has sealants or fluoride releasing cements on the buccal surface of the anterior teeth
* in-office fluoride treatment in the last three months
* history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months
* intrinsic or extremely heavy extrinsic staining
* any signs of fluorosis in the dentition
* any signs of morphologic/anatomical/developmental deviations in the teeth
* previous history of in office bleaching treatment
* subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested
* has underlying systemic disease which could alter enamel composition or formation
* suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
* use of medication causing dry mouth (extreme high caries risk)
* subject is pregnant or lactating
* milk protein allergy
* any illness/condition that the investigator feels will affect the study outcome
* will leave the area and will not be available for recall visits
* subjects who are not willing to inform us about prospective visits of other dentist and will not allow us to discuss treatment with those dentist
* subjects who are not willing to refrain from any additional professional tooth cleaning or any additional Fluoride application.