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MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study

NCT02424097 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-22

Study results available
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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.

Conditions

  • Dental White Spots
  • Dental Caries

Interventions

DRUG

CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste

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

DRUG

1,100pm F-toothpaste and 0.5%NaF rinse

Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)

Sponsors & Collaborators

Principal Investigators

  • Peter Rechmann, DMD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424097 on ClinicalTrials.gov