ArticleFrontiers in oral health2026
Three-arm randomized controlled trial evaluating the effectiveness of the self-assembling peptide P11-4 in the remineralization of enamel carious white spot lesions: a study protocol.
Article in Frontiers in oral health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07664046 (A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions), which is not on this map. Not yet cited in PubMed.
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A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions
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5 authors.
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Abstract
Background: Enamel carious white spot lesions (WSLs) represent early-stage demineralization that may progress to cavitated lesions requiring invasive treatment. The self-assembling peptide P11-4 (SAP P11-4) is a biomimetic agent designed to promote enamel remineralization by forming a biomatrix that attracts calcium and phosphate ions and supports hydroxyapatite formation. Although evidence supports its efficacy, the optimal application protocol remains unclear, and no clinical trial has directly compared single vs. repeated SAP P11-4 application. Objective: To compare the remineralization efficacy of repeated vs. single SAP P11-4 application in adolescents with enamel carious WSLs at the prespecified 6-month primary time point, while also evaluating both SAP P11-4 regimens against fluoride varnish alone over 12 months. Methods: This three-arm, partially blinded, randomized controlled trial will enroll participants aged >10 and <18 years with at least two active enamel carious WSLs on smooth surfaces of permanent teeth. Participants will be randomly allocated 1:1:1 to Group A (single SAP P11-4 application + FV), Group B (SAP P11-4 applications at baseline and 3 months + FV), or Group C (FV alone). The planned sample size is 75 participants (25 per group). The primary outcome is the change in the QLF-derived lesion volume parameter (Δ Results: The study was approved by the Bioethics Committee of the Medical University of Warsaw (KB/1/2026, 12 January 2026). Recruitment is planned to commence in February 2026, with study completion expected in July 2027. Conclusions: This trial will provide evidence on the comparative efficacy of single vs. repeated SAP P11-4 application and inform an evidence-based clinical protocol for managing enamel WSLs in adolescents. Clinical Trial Registration: https://clinicaltrial.gov/, identifier NCT07664046.
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