MI Varnish for the Prevention of White Spot Lesions

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Orthodontic Treatment; White Spot Lesion

Treatments: Drug: MI Varnish; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03446690

1135815

Details and patient eligibility

About

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.

Full description

Orthodontists face two common iatrogenic treatment side effects, root resorption and enamel decalcification, with the latter occurring at a much higher frequency. While the processes that lead to enamel demineralization are understood, methods to diminish or perhaps eliminate degradation of enamel surfaces are being searched for. A new product, MI Varnish, is current available and has been shown in some initial case reports to be useful in reducing white spot lesions. It contains a special milk-derived protein RECALDENT TM (CPP-ACP) in which the casein phosphopeptides (CPP) bind to teeth, dentin, and oral mucosa while the amorphous calcium phosphate (ACP) releases calcium and phosphate. 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. The study group received the MI Varnish on the day of bracket bonding. Subjects were recalled initially for 4 weeks (twice) and then at 3 monthly intervals. 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.

Enrollment: 62 patients

Sex: All

Ages: 10 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes.

Exclusion criteria

• Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study;
• Patient is currently using any investigational drug or any other investigational device;
• Patient plans to relocate or move within six months of enrollment.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

MI Varnish Group

Experimental group

Description:

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.

Treatment:

Drug: MI Varnish

Control group

Other group

Description:

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.

Treatment:

Other: Control group