CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
MI Varnish +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03446690
NCT03446690Phase 4Completed

The Use of MI Varnish for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment

University of Alabama at Birmingham·interventional·Posted Feb 27, 2018·Updated Jun 26, 2023

In Brief

A Phase 4 clinical trial evaluating MI Varnish and Control group for White Spot Lesion and Orthodontic Treatment. Completed, enrolled 62 participants.

Detailed Summary

The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartJan 1, 2015
Primary CompletionNov 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.3 years ago

Interventions

MI Varnishdrug

MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.

Control groupother

Participants received routine treatment and oral hygiene regimes. No intervention for this group.