Effect of MI Paste Plus™ on Streptococcus Mutans Counts and White Spot Lesions in Patients With Fixed Orthodontic Appliances: A Triple-Blind Clinical Trial

What this Trial Is About

This research aims to assess the effects of MI Paste Plus, a dental cream containing fluoride and casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), on the levels of Streptococcus mutans bacteria and the development of white spot lesions (WSLs) in patients undergoing fixed orthodontic treatment. Fixed orthodontic appliances like brackets and auxiliary devices can promote bacterial growth and enamel demineralization, leading to WSLs that affect tooth appearance and integrity. The study is a prospective, triple-blind, randomized clinical trial involving 200 patients aged 5 to 45 years. Participants will be divided into two groups: one group will apply MI Paste Plus once nightly after brushing for three months, while the other group will use a placebo bioadhesive gel with no active ingredients under the same conditions. Both gels look and feel identical to maintain blinding. Participants will continue regular toothbrushing with fluoridated toothpaste. The study also includes stratification by age, oral hygiene risk, and appliance type, with assessments at baseline, one month, and three months. During the study, saliva samples will be collected and analyzed to measure Streptococcus mutans counts. Dental examinations will evaluate white spot lesions using visual inspection (ICDAS) and quantitative light-induced fluorescence imaging to detect enamel demineralization. Adherence to gel application will be monitored through logs and weighing returned containers. Data collected will help determine if MI Paste Plus reduces bacterial levels and prevents or lessens WSLs during orthodontic treatment.

Effect of MI Paste Plus™ on Streptococcus Mutans and White Spot Lesions in Fixed Orthodontics