Title: 0456 - RCT Investigating the Efficacy of Self-Assembling Peptide for Early Caries
Alaa Mannaa, King Abdulaziz University
Paulina Sedlakova (Presenter)
University of Geneva
Claudine Bommer, credentis ag
Enrico di Bella, University of Genoa
Ivo Krejci, University of Geneva
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.
This abstract is based on research that was funded entirely or partially by an outside source:
CTI- Committee of Technology and Innovation (Innosuisse)
The submitter must disclose the names of the organizations with which any author have a relationship, the nature of the relationship, and the clinical or research area involved. The following is submitted: Claudine Bommer is an employee of credentis ag