MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
Condition: Dental White Spots; Dental Caries
MeSH terms: Dental Caries
Intervention: CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste; 1,100pm F-toothpaste and 0.5%NaF rinse
Intervention description: MI Paste & MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray; Standard of care at-home:
Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention

Summary:

      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.
    

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.