MI Varnish for the Prevention of White Spot Lesions
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|ClinicalTrials.gov Identifier: NCT03446690|
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|White Spot Lesion Orthodontic Treatment||Drug: MI Varnish Other: Control group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Use of MI Varnish for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment|
|Actual Study Start Date :||January 1, 2015|
|Actual Primary Completion Date :||November 1, 2015|
|Actual Study Completion Date :||January 1, 2016|
Experimental: MI Varnish Group
33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
Drug: MI Varnish
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.
A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham. No intervention for this group.
Other: Control group
Participants received routine treatment and oral hygiene regimes. No intervention for this group.
- Enamel Decalcification Index (EDI) Scores [ Time Frame: Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months. ]Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446690
|Principal Investigator:||Chung H Kau, BDS, PhD||University of Alabama at Birmingham|