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.

Full record on ClinicalTrials.gov (NCT ID NCT02424097).

Full results record on ClinicalTrials.gov.

Phase

Phase 4

Study type

Interventional

Allocation

Randomized

Masking

Single-blind

Intervention model

Parallel assignment

Primary purpose

Prevention

Enrollment (final)

40 participants

Actually completed

October 2016

Age range: ≥ 11 · Sex: All · Healthy volunteers: Accepts

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.