Efficacy of P11-4 for the treatment of initial buccal caries: a randomized clinical trial

Abstract

To investigate the safety and efficacy of Self-Assembling Peptide P11-4 (SAP P11-4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P11-4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P11-4 lesions (test, D90–D0) showed significant WSL size reduction compared to placebo (control, D90–D0; p = 0.008) or FV (control, D180–D90; p = 0.001). Combination of SAP P11-4 and delayed FV after 90 days (test, D180–D0), showed a significant difference compared to FV alone (control D270–D90; p = 0.003). No significant difference on FV efficacy was found when SAP P11-4 was applied 3 months before FV (test D270–D90; control D270–D90, p = 0.70). SAP P11-4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P11-4. SAP P11-4 was found to be a safe and effective WSL treatment.

Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine

“…One other SAP is currently approved for clinical use by regulatory authorities besides RADA16, an 11 amino acid peptide (QQRFEWEFEQQ) known as PF 11 -4 (commercial name Curodont TM Repair) that promotes remineralization and regression in early dental caries (Alkilzy et al, 2018;Sedlakova Kondelova et al, 2020). This review focuses on the evolution of applying RADA16 for surgical bleeding control and provides an overview of studies indicating the great potential of this unique FIGURE 3 | Illustration of RADA16 structure and properties as it is applied to and gels on a wound site.…”

Effectiveness of Self-Assembling Peptide (P11-4) in Dental Hard Tissue Conditions: A Comprehensive Review

“…The mean calcium/phosphate weight percentage ratio of P11-4 was significantly lower than the others Enamel [29] Clinical study to investigate SAPM gel compared to 8% arginine and calcium carbonate toothpaste for treatment of dentin hypersensitivity Significant reduction of dentin hypersensitivity, with the patient questionnaire indicating higher patient satisfaction Dentin [51] Effect of P11-4 on non-cavitated initial proximal carious lesions 12 months after treatment Radiographic and digital subtraction analyses suggest that initial proximal carious lesions can regress after treatment with P11-4 Enamel [30] Re-hardening potential of enamel matrix derivatives (EMD) and self-assembling peptides in vitro A significant re-hardening up to 125 pm was observed Enamel [31] In vivo efficacy of self-assembling peptide P11-4 compared to placebo or fluoride varnish P11-4 treatment resulted in superior caries regression compared to either placebo or fluoride varnish Enamel [32] In vitro regeneration of enamel in natural early caries lesions and evaluated over 50 days by photothermal radiometry and luminescence P11-4 promoted the regeneration of early caries Enamel [33] Effect of P11-4 to remineralise artificial carious lesions in enamel in vitro using a 30-day pH cycling model through surface microhardness analysis and SEM P11-4 remineralised the enamel lesions more effectively, and SEM photomicrographs demonstrated either amorphous crystals or particles scattered on the surface or lines of remineralisation along the prismatic borders Enamel [35] Ultrasonography to evaluate the effect of the self-assembling peptide P11-4 on acid erosion prevention on bovine enamel P11-4 peptides on erosive lesions can improve remineralisation Enamel [53] Remineralising efficacy of NovaMin, CPP-ACP, silver diamine fluoride (SDF), and P11-4…”

“…Moreover, in-depth mineralisation does not occur [35]. This necessitates the use of therapy to regenerate a mineral deficiency in the tooth enamel due to a carious lesion [21,23,24,26,32,38,40,67,68] and could be termed as 'Guided Enamel Remineralisation' (GER). Dentin, too, has the potential to undergo such biomimetic remineralisation [21,50,51].…”

Self-Assembling Peptides: From Design to Biomedical Applications

“…Glutamine residues at both extremities drive the self-assembling process, lead to the formation of βsheet structures, and further form higher-order nanostructures (e.g., nanofibers and fibrils). P 11 -4 is used to treat dental caries (remineralization and regression in early dental caries) and in particular to allow enamel regeneration [149,150]. Indeed, when monomeric SAP P 11 -4 is injected in the carious lesion surface, it is able to diffuse into the lesion and self-assemble into nanotapes forming a hydrogel network that mimics the endogenous microenvironment necessary for enamel deposition.…”

“…P 11 -4 is used to treat dental caries (remineralization and regression in early dental caries) and in particular to allow enamel regeneration [ 149 , 150 ]. Indeed, when monomeric SAP P 11 -4 is injected in the carious lesion surface, it is able to diffuse into the lesion and self-assemble into nanotapes forming a hydrogel network that mimics the endogenous microenvironment necessary for enamel deposition.…”