RCT Investigating the Efficacy of Self-Assembling Peptide for Early Caries

Objectives: To evaluate the efficacy of Self-Assembling Peptide (SAP) P11-4 in treatment of early buccal carious lesions compared to placebo or the gold-standard fluoride varnish (Duraphat 22’600ppm fluoride). Methods: 44 subjects with two early buccal carious lesions were included in this quadruple-blinded, randomized, gold-standard and placebo controlled split-mouth trial with sequential design. SAP P11-4 and placebo were applied at D0 to test and control tooth respectively, and fluoride varnish was applied on D90 to both control and test tooth. Additional follow-ups were at D30, D180 and D270. Primary parameter was the difference in the change of the lesion’ s size as assessed by morphometry on standardized photographs between SAP P11-4 treatment and placebo for the time interval D0-D90 (test and control), and between SAP P11-4 (test group: time interval D0-D90) and fluoride varnish (control group: time interval D90-D180). Results: Morphometric analysis demonstrated significantly higher remineralizing effect of SAP P11-4 (-19%) compared to placebo (-4%) after 90 days (p=0.0015), for SAP P11-4 compared to fluoride varnish (-4%) after 90 days (p=0.0016), and SAP P11-4 with a delayed fluoride varnish (-20%) compared to fluoride varnish alone (-4%) after 180 days (p=0.0032). SAP-P11-4 treatment did not influence the efficacy of fluoride varnish, as there was no statistically significant difference in remineralisation after 90 (D180-D90) and 180 days (D270-D90) following fluoride varnish application in test and control group on D90. Conclusions: Under the conditions of this clinical trial Self-Assembling Peptide P11-4 caused significantly higher remineralisation when compared to both placebo and gold-standard (fluoride varnish) as assessed by the morphometric regression of early buccal carious lesions.