S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment

Overview

White spot lesions are early areas of enamel demineralization that may develop during orthodontic treatment with fixed braces. This study aims to evaluate the effectiveness of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. The study will compare S-PRG Barrier Coat with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. A total of 144 participants undergoing orthodontic treatment will be randomly assigned to one of four treatment groups. The occurrence and severity of white spot lesions will be assessed using clinical examinations, including the ICDAS-II and Gorelick index, together with DIAGNOdent readings where applicable. The study findings may help determine whether S-PRG Barrier Coat provides an effective preventive approach against orthodontic white spot lesions.

White spot lesions (WSLs) are early manifestations of enamel demineralization that may occur during orthodontic treatment with fixed appliances. Brackets and archwires can increase plaque accumulation and make oral hygiene more difficult, potentially increasing the risk of enamel demineralization. Although fluoride-based preventive measures are commonly used, additional preventive approaches may be beneficial. S-PRG (Surface Pre-Reacted Glass-ionomer) bioactive fillers have the potential to release various ions, including fluoride and strontium, which may contribute to the inhibition of demineralization and promotion of remineralization. S-PRG Barrier Coat is therefore being investigated as a potential preventive material for orthodontic WSLs. Study Objective The objective of this study is to evaluate the effect of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. Its preventive effect will be compared with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. Study Design This is a single-center, four-arm, parallel-group, randomized controlled clinical trial involving patients undergoing orthodontic treatment with fixed appliances. A total of 144 participants will be recruited and randomly allocated in a 1:1:1:1 ratio to four treatment groups, with 36 participants planned for each group. Intervention Groups S-PRG Barrier Coat. 5% sodium fluoride varnish. Combined S-PRG Barrier Coat and 5% sodium fluoride varnish. Placebo. Study Procedures and Assessments Eligible participants will be recruited from the orthodontic clinic following assessment against the study inclusion and exclusion criteria. Written informed consent will be obtained before participation. Baseline assessments will be conducted according to the study protocol, followed by the application of the assigned intervention. Participants will be followed during orthodontic treatment to assess the occurrence and severity of WSLs. Clinical assessments will include the International Caries Detection and Assessment System (ICDAS-II) and the Gorelick index. DIAGNOdent readings may also be used as a diagnostic assessment of enamel demineralization, according to the approved study protocol. Clinical and diagnostic findings will be recorded and compared among the treatment groups. Randomization and Blinding Participants will be randomly allocated to one of the four treatment groups. The study is designed as a double-blind randomized controlled trial. The specific individuals blinded to treatment allocation will follow the approved study protocol. Expected Contribution This study may provide evidence on whether S-PRG Barrier Coat, alone or in combination with fluoride varnish, offers a preventive benefit against orthodontic WSLs compared with fluoride varnish alone and placebo. The findings may contribute to the development of preventive strategies for enamel demineralization during orthodontic treatment.