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

A Jablonski-Momeni,H Korbmacher-Steiner,M Heinzel-Gutenbrunner,B Jablonski,P Bottenberg,W Jaquet

doi:10.1038/s41598-018-36536-4

A Jablonski-Momeni, H Korbmacher-Steiner + Show 4 more

Open Access

https://doi.org/10.1038/s41598-018-36536-4

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Abstract

The aim was to investigate the ability of self-assembling Peptide P11-4 Matrix (SAPM) to remineralize artificial initial caries lesions compared to the use of fluoride varnish. Volunteers were recruited for this randomised, cross-over in situ trial. Bovine specimens, half including orthodontic brackets, were recessed on the buccal aspects of mandibular appliances. Specimens included internal sound enamel control, a demineralised control and a part exposed during the in situ phase. Each phase lasted four weeks, followed by a one-week washout. Treatment groups were: A: negative control, no treatment,B: positive control, 22,600 ppm fluoride varnish,C: test group, 1,000 ppm SAPM. Laser fluorescence values (LF) were measured before/after demineralisation, and after the in situ period. Micro-CT analysis was used to assess mineral changes within the specimens after the in situ phase. In specimens without brackets, ΔLF values after in situ phase were: A: +5.28, B: +0.85, C: −2.89. Corresponding ΔLF for specimens with brackets were: A: +5.77, B: +1.30, C: −3.15. LF-values between groups significantly differed from each other (p < 0.0001) after the in situ phase. Micro-CT analysis yielded no significant difference among groups for specimens without brackets. For specimens with brackets, the test group showed significantly more remineralisation than the negative (p = 0.01) and positive control (p = 0.003). Within the limitations of the study, SAPM showed prevention of caries and remineralisation of enamel around orthodontic brackets.

Highlights

Caries is the most common disease in the world as reported by the Global Burden of Disease Study[1]
The study shows that the self-assembling Peptide P11-4 Matrix (SAPM) has a clinical beneficial effect in caries prevention, as has been previously shown in vitro[26,27]
The use of the home care SAPM-based product proved to be useful in preventing the progression of initial demineralisation, especially around orthodontic brackets

Summary

Introduction

Caries is the most common disease in the world as reported by the Global Burden of Disease Study[1]. As caries progression is initiated by an imbalance of the remineralisation-demineralisation equilibrium favouring demineralisation[2,3,4], any prevention should aim at shifting the equilibrium back towards remineralisation This will lead to arrest of progression or even to regression of caries lesions[5,6]. In order to prevent formation of white spot lesions, high-risk patients are often subject to a strict oral hygiene regimen, including application of products containing fluoride and calcium phosphate[11,12]. Recent studies have shown the limitations of fluoride when caries lesions have already progressed to the clinically manifest white spot stadium, leading at best to an arrest of the www.nature.com/scientificreports/. The biomimetic strategies aim at mineralisation of the subsurface caries lesion leading to additional mineralisation, whereas fluoride acts mainly in the superficial mineral layer of the caries lesion[18]

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Conclusion