Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P₁₁-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P₁₁-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P₁₁-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P₁₁-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs ( ClinicalTrials.gov NCT02724592).

Minimal invasive approaches to managing caries, such as partial caries removal techniques, are showing increasing evidence of improved outcomes over the conventional complete caries removal. There is also increasing interest in techniques where no caries is removed. We present the 1-yr results of clinical efficacy for 3 caries management options for occlusoproximal cavitated lesions in primary molars: conventional restorations (CR; complete caries removal and compomer restoration), Hall technique (HT; no caries removal, sealing in with stainless steel crowns), and nonrestorative caries treatment (NRCT; no caries removal, opening up the cavity, teaching brushing and fluoride application). In sum, 169 children (3-8 yr old; mean, 5.56 ± 1.45 yr) were enrolled in this secondary care–based, 3-arm, parallel-group, randomized clinical trial. Treatments were carried out by specialist pediatric dentists or postgraduate trainees. One lesion per child received CR, HT, or NRCT. Outcome measures were clinical failure rates, grouped as minor failure (restoration loss/need for replacement, reversible pulpitis, caries progression, etc.) and major failure (irreversible pulpitis, abscess, etc.). There were 148 children (87.6%) with a minimum follow-up of 11 mo (mean, 12.23 ± 0.98 mo). Twenty teeth were recorded as having at least 1 minor failure: NRCT, n = 8 (5%); CR, n = 11 (7%); HT, n = 1 (1%) (p = .002, 95% CI = 0.001 to 0.003). Only the comparison between NRCT and CR showed no significant difference (p = .79, 95% CI = 0.78 to 0.80). Nine (6%) experienced at least 1 major failure: NRCT, n = 4 (2%); CR, n = 5 (3%); HT, n = 0 (0%) (p = .002, 95% CI = 0.001 to 0.003). Individual comparison of NRCT and CR showed no statistically significant difference in major failures (p = .75, 95% CI = 0.73 to 0.76). Success and failure rates were not significantly affected by pediatric dentists’ level of experience (p = .13, 95% CI = 0.12 to 0.14). The HT was significantly more successful clinically than NRCT and CR after 1 yr, while pairwise analyses showed comparable results for treatment success between NRCT and CR (ClinicalTrials.gov NCT01797458).

Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).

Modern approaches in caries treatment involve lesion management without tissue removal. Regenerative medicine focuses on replacing damaged tissues with biologically similar tissues. This article discusses the scientific evidence and clinical results for self-assembling peptides in modern caries management. The biomimetic remineralization promoted by self-assembling peptide P11-4 has been proven in vitro as an effective therapy for initial caries. P11-4 was rationally designed to promote formation of hydroxyapatite on its surface. The formulation was optimized to ensure the ability of monomeric P11-4 to penetrate past the subsurface lesions and assembly into a biomatrix within. Furthermore, P11-4 has shown that it assembles into fibers within carious lesions, and promotes the remineralization thereof. In a recent clinical study, the safety and efficacy of P11-4 in treatment of initial caries were evaluated. The additional effect of the application of P11-4 (Curodont Repair) was compared to the application of fluoride varnish (Duraphat) alone in active occlusal initial caries lesions on erupting permanent molars. In the 3- and 6-month recalls, the test group showed, both in the laser fluorescence readings and in the clinical assessment of the caries stage and activity, significantly superior lesion regression compared to the control group. No adverse events, medical complications, or allergic reactions related to the treatments were reported. Clinical applicability of treatment was regarded as satisfactory. Patients were happy to receive noninvasive caries treatments. In conclusion, biomimetic mineralization facilitated by P11-4 in combination with fluoride may present a simple, safe, and effective noninvasive treatment for early carious lesions.