Systematic Review and Meta-Analysis on the Effect of Self-Assembling Peptide P₁₁-4 on Initial Caries Lesions

Abstract

Background: Dental caries remains a global problem that causes disproportionate suffering in underserved populations. Simple interventions are needed to improve patient experience, clinical and cost-effectiveness, and access to care. The self-assembling peptide P11-4 is a recently developed, non-invasive treatment that regenerates enamel in initial caries lesions. Studies reviewed: We conducted a systematic review and meta-analysis on the effectiveness of the P11-4 products CurodontTM Repair (CR) and CurodontTM Repair Fluoride Plus (CRFP) on initial caries lesions. Primary outcomes were lesion progression after 24 months, caries arrest, and cavitation. Secondary outcomes were changes in merged International Caries Detection and Assessment System (ICDAS) score, Quantitative Light Fluorescence, esthetic appearance, and lesion size. Results: Six clinical trials comparing CR to controls met the inclusion criteria. Results of this review represent two primary and two secondary outcomes. When compared to parallel groups, CR improved caries arrest (RR: 1.82; 95% CI: 1.32 to 2.50; 45% attributable risk; 95% CI: 24 to 60%) and decreased lesion size by 32% (Hedge g: -0.59; CI: -1.03 to -0.15). We observed positive trends for avoiding cavitation (RR: 0.32; CI: 0.10 to 1.06) and lowering merged ICDAS score (RR: 3.68; CI: 0.42 to 32.3). No studies used CRFP or reported adverse esthetic changes. Practical implications: CR has a treatment effect on caries arrest and decreased lesion size. Two trials contributing to the caries arrest result had non-masked assessors, and all trials had elevated risks of bias. We recommend conducting longer trials. CR is a promising treatment for initial caries lesions.

SDF, SAP P11-4, and GI Sealants for Managing Initial Caries Lesions Produce Clinic and Payor Savings in Financial Impact Model

“…The drivers of payor cost savings and clinic net profit for SDF and/or Curodont scenarios are minimal treatment times, combined Treatment of initial lesions with traditional restorations is extremely common, as 94% of US dentists report restoring initial lesions 5 while only 11%-12% of control group initial lesions progress. 6,21 This disconnect may be due to the ubiquitous misunderstanding that radiographic appearance of demineralization reaching the dentin necessarily indicates cavitation. 5,22,23 However, international guidelines recommend against restoring initial lesions as these lesions can be healed, or arrested, through remineralization.…”

“…Clinical effectiveness with no treatment was calculated as the weighted mean of control outcomes in two systematic reviews of noninvasive therapies. 6,21 The time and costs for treating failures are considered for one tooth in one anatomic area, regardless of the number of initial lesions per patient (the efficiencies of multiple lesions treated in one patient do not apply).…”

“…2,3 Tooth-specific noninvasive caries therapies include silver diamine fluoride (SDF), Curodont Repair Fluoride Plus (Curodont), and glass ionomer sealants, among others. 3,6,7 Noninvasive therapies have similar clinical outcomes to more invasive treatments without irreversibly removing tooth structures, are completed quickly and painlessly, and are often reimbursed by payors (e.g., Medicaid). However, to our knowledge, the profitability of noninvasive therapies for dental teams and cost-savings for payors compared to predominant current practice have not yet been studied.…”

“…Curodont regenerates hydroxyapatite within the porous enamel of an initial lesion by absorbing into the lesion, self-assembling into scaffolds that span throughout the demineralized volume, and templating calcium and phosphate from the saliva into new hydroxyapatite. 11 Curodont has clinically important effects on arresting caries and shrinking initial lesions 6,7 while being safe. 12 In January 2019, Curodont was added to the US Food and Drug Administration's National Drug Codes Directory under the Over the Counter Anticaries Drug Monograph (NDC: 72247-101).…”

Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: Randomized Controlled Clinical Trial

“…However, resin in ltration led to the greatest lesion regression, followed by uoride varnish then P11-4 on white spot buccal lesions in permanent (23) . Two systematic reviews based on seven clinical trials of P11-4 showed that it improved caries arrest, decreased lesion size and lowered ICDAS scores (24)(25) .…”