Randomised in situ clinical trial investigating self-assembling peptide matrix P11-4 in the prevention of artificial caries lesions

Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P 11-4 (SAP P 11-4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standardcontrolled clinical trial. Test Group 1 received SAP P 11-4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P 11-4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P 11-4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone. Caries levels have significantly decreased over the past decades, partially due to the introduction of fluoride in various forms 1. However, despite the promising efforts and results worldwide, caries levels have remained high, and caries is still the most common disease worldwide 2. Recent efforts to lower caries levels have focused on treating early carious lesions non-invasively, as there is consensus that only early intervention, prior to cavitation, can lead to a regression of the caries to a more healthy state 3,4. Novel therapeutics have been called for, and promising approaches are based on biomimetic research and development. Biomimetic concepts fall into two categories, either based on amelogenin or derivatives thereof, or on rationally designed and screened systems 5,6. There is substantial research in the field, yet most of it is in vitro-based. The exceptions are recent clinical investigations of the rationally designed self-assembling peptide P 11-4 applied either in its monomeric form (SAP P 11-4) 5,6 or its polymeric form as a self-assembled peptide matrix (SAPM). This is the first clinical trial investigating the combined effect of SAP P 11-4 and SAPM in treatment of early carious lesions. SAP P 11-4 has been systematically investigated 7. The self-assembling peptide was rationally designed to provide favourable physicochemical characteristics for nucleation of hydroxyapatite (HA) on the surface of the formed fibres of the 3D matrix 8,9. The mechanism of action of SAP P 11-4 in the remineralization of enamel was proposed early on and has been proven since 10,11. When monomeric SAP P 11-4 is applied onto th...

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confidence: 95%

Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries

Doberdoli

Bommer

Begzati

et al. 2020

“…The WSL persist visually almost unchanged 12-14 . Other remineralisation agents, often based on calcium phosphate, have been investigated, but could not show clinically significant advantage over fluoride 10,11,[15][16][17] .As a consequence, new treatment approaches have been called for and biomimetic mineralisation seems to be one promising possibility [18][19][20][21][22] . However, the only clinically available products at present are based on the self-assembling peptide P 11 -4 (SAP P 11 -4) 21 .The mode of action for the treatment of initial caries with SAP P 11 -4 is as follows 23,24 .…”

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confidence: 99%

“…As a consequence, new treatment approaches have been called for and biomimetic mineralisation seems to be one promising possibility [18][19][20][21][22] . However, the only clinically available products at present are based on the self-assembling peptide P 11 -4 (SAP P 11 -4) 21 .…”

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confidence: 99%

Effect of self-assembling peptide P11-4 on orthodontic treatment-induced carious lesions

Welk

Ratzmann

Reich

et al. 2020

This study aimed to evaluate the effect of self-assembling peptide P 11 -4 (SAP) in the therapy of initial smooth surface caries (white spot lesions, WSL) following orthodontic multibracket treatment. Twentythree patients (13f/10m; average age 15.4 years) with at least two teeth with WSL were recruited for the randomised controlled clinical trial with split-mouth design. In opposite to the control teeth, the test teeth were treated with SAP on Day 0. The primary endpoint was the impedance measurement of WSL using customised tray to ensure reproducibility of the measurement location. The secondary endpoint was the morphometric measurement of WSL using a semi-automated approach to determine the WSL size in mm 2 . Treatment effects were adjusted for site-specific baseline values using mixed models adapted from the cross-over design. Test WSL showed a mean baseline impedance value of 46.7, which decreased to 21.1, 18.4, and 19.7 after 45, 90, and 180 days, respectively. Control WSL showed a mean baseline value of 42.0, which decreased to 35.0, 29.5, and 33.7, respectively. The overall treatment contrast was −13.7 (95% CI: −19.6 -−7.7; p < 0.001). For the secondary endpoint, the test WSL size decreased from 8.8 at baseline to 6.5 after 180 days. The control WSL decreased from 6.8 to 5.7, respectively. The related treatment contrast was −1.0 in favour of test WSL (95% CI: −1.6 -−0.5; p = 0.004). The treatment of initial carious lesions with self-assembling peptide P 11 −4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.Orthodontic treatments with fixed multibracket appliances hindering oral hygiene, support plaque accumulation, and caries progression 1,2 . These orthodontic treatment-induced carious lesions are typically visible first as so-called white spot lesions (WSL) on the buccal surface of the tooth outlining the brackets 3-6 .Modern treatment concepts for caries emphasise tooth preservation and remineralisation concepts especially for initial non-cavitated carious lesions, in order to hinder or to delay the first invasive intervention, meaning destruction of the natural tooth structure 7 .Unique for buccal WSL is the addition of an aesthetic component to the cariological issue 3,8 . Fluorides prevent the formation of so-called white spot lesions (WSL) but have shown little effect on the reduction of existing WSL 9-11 . As their effect is restricted to the outer surface layer of the enamel (i.e. top 50 µm) and does not promote the remineralisation throughout the demineralised lesion body. The WSL persist visually almost unchanged 12-14 . Other remineralisation agents, often based on calcium phosphate, have been investigated, but could not show clinically significant advantage over fluoride 10,11,[15][16][17] .As a consequence, new treatment approaches have been called for and biomimetic mineralisation seems to be one promising possibility [18][19][20][21][22] . However, the only clinically available products at present are based on the self-assembling peptide P 11 -4 ...

“…The evaluation was performed visually and hence the interpretation of the size reduction was subjective. Results from a randomized in-situ study demonstrated the superior remineralising effect of the self-assembling peptide compared to fluoride use on demineralised bovine enamel 28 . The applied gel contained 1,000 ppm P 11 -4 and 900 ppm fluoride, recommended for homecare prevention.…”

Section: Discussionmentioning

confidence: 98%

Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets

Jablonski-Momeni

Nothelfer

Morawietz

et al. 2020

Self Cite

Enamel demineralisation can occur as a side effect during orthodontic treatment with fixed appliances. This study aimed to evaluate the efficacy of the self-assembling peptide P11-4 for remineralisation combined with fluorides, compared to application of fluoride varnish alone. De- and remineralisation was assessed by Quantitative light-induced fluorescence (QLF). Orthodontic brackets were bonded on 108 human enamel samples and white spot lesions were created. The samples were allocated randomly into three groups: Group I received no treatment, group II had a single application of fluoride varnish (22,600 ppm), and group III was treated with P11-4 following a single application of fluoride varnish. Quantitative light-induced fluorescence (QLF) measurements were performed at baseline, after demineralisation and after storage in remineralisation solution for 7 and 30 days. Non-parametric tests (Kruskal–Wallis test and Friedman test) were used for further analysis. After demineralisation, all samples showed a median ΔF -9.38% ± 2.79. After 30 days median ΔF values were as followed: group I = -9.04% ± 2.51, group II = -7.89 ± 2.07, group III = -6.08% ± 2.79). The median ΔF values differed significantly between all groups at all investigation times (p < 0.00001). Application of P11-4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.