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

Abstract

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 ...

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

“…However, the present results add evidence to two previously reported SAP P 11 -4 studies on occlusal caries, but as these studies did not include a treatment group solely receiving SAP P 11 -4, inhibitory effects of SAP P 11 -4 on fluoride varnish could not be excluded. It should be noted that the WSLs treated with SAP P 11 -4 in the present clinical trial did not disappear completely, in agreement with previous reports 15,21,25 and consistent with the fact that the formed hydroxyapatite crystals formed on the SAP P 11 -4 scaffold surface show a fan-type structure not a prismatic arrangement 10 and thus do not result in the same translucency as natural prismatic enamel. The changes in the white spot lesion should be and were in the present study regarded as a surrogate parameter and not a direct measure of caries or a clinical success parameter.…”

“…The results of the present trial are consistent with previous clinical studies on SAP P 11 -4 15,17,18,21,22 , indicating that SAP P 11 -4 could be a suitable clinical option for the non-invasive treatment of early carious lesions, allowing a more comprehensive and in-depth regression of decayed enamel 7,26 .…”

“…Lesions of subjects who had an orthodontic treatment and finished it more than one year before study inclusion were not classified as lesions originating from orthodontic treatment. Notably, white spot lesions originating from orthodontic treatment, known to have a partial remineralization potential without any treatment 20,21 were absent in the present study. In total, 44 tooth-pairs (one per subject) were randomly assigned to either test or control treatment arm and analysed.…”

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

“…Hence, the additional treatment with P 11 -4 may decrease the risk of development of initial caries lesions during fixed orthodontic treatment. www.nature.com/scientificreports/ Welk et al 29 could show the effect of P 11 -4 on orthodontic treatment induced carious lesions after the orthodontic multibracket treatment. The authors concluded that treatment of initial carious lesions with P 11 -4 led to better remineralisation of the subsurface lesions compared with the control teeth.…”

“…The efficacy of P 11 -4 in remineralisation of early enamel lesions was shown using different detection methods such as laserfluorescence (DIAGNOdent) 27,28 or impedance measurements 29 . But no published data are available using QLF as a reference standard.…”