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Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries

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Abstract

Objectives

This prospective, randomised, split-mouth, clinical trial compared the efficacy of the self-assembling peptide P11-4 to fluoride varnish in the treatment of early buccal carious lesions.

Materials and methods

Subjects presenting at least two clinically affected teeth were treated at D0 (day 0) and D90 with P11-4 (test) or fluoride varnish (control). At D180, fluoride varnish was applied on all study lesions. Standardised photographs were taken at D0, D30, D90, D180 and D360 and blindly morphometrically assessed. Hierarchical linear models (HLM) under allowance of confounders were used to compare the decrease in size between test and control groups. The visual analog scale (VAS) and Global Impression of Change Questionnaire (GICQ) were used as clinical assessments.

Results

Overall, 37 subjects (13–36 years) with 90 early carious lesions were included. HLM analysis showed a significant difference between test and control groups, indicating a decrease in test lesions and stabilisation of control lesions size (p = 0.001). The test lesion’s mean size (SD) relative to baseline decreased to D30 = 0.936(0.127), D90 = 0.874(0.173), D180 = 0.844(0.215) and D360 = 0.862(0.352), whereas control lesions remained stable at D30 = 1.018(0.209), D90 = 1.013(0.207), D180 = 1.029(0.235) and D360 = 1.068(0.401). The effect sizes ranged from 0.47 to 0.82.

Conclusions

Within the limits of this study, it was shown that the size of early carious lesions treated with P11-4 was significantly reduced; this result was superior to that of fluoride varnish treatment (DRKS00012941).

Clinical relevance

The self-assembling peptide P11-4 is the first caries treatment approach aiming to regenerate decayed enamel. P11-4 initiates formation of de novo hydroxyapatite in the depth of early carious lesions, adding a new advanced therapy option for preventive dentistry.

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Acknowledgements

The authors thank Ms. Jaqueline Schröder, ZFA, staff of Private Practice Periodontology, Aachen/Germany for serving as study nurse throughout the entire project.

Funding

The work was supported by credentis ag, Windisch, Switzerland. F. Bröseler, C. Tietmann and M. Heinzel-Gutenbrunner received compensation for the work performed within the clinical study.

Author information

Author notes

  1. F. Bröseler and C. Tietmann contributed equally to this work.

Authors and Affiliations

  1. Private Practice for Periodontology, Aachen, Germany

    F. Bröseler & C. Tietmann

  2. credentis ag, Windisch, Switzerland

    C. Bommer

  3. Department of Operative and Preventive Dentistry, University of Bonn, Bonn, Germany

    T. Drechsel & S. Jepsen

  4. MH Statistical Consulting, Marburg, Germany

    M. Heinzel-Gutenbrunner

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  1. F. Bröseler
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Bröseler, F., Tietmann, C., Bommer, C. et al. Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries. Clin Oral Invest 24, 123–132 (2020). https://doi.org/10.1007/s00784-019-02901-4

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