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

Dafina Doberdoli, Claudine Bommer, Agim Begzati, Fehim Haliti, Monika Heinzel-Gutenbrunner, Hrvoje Juric, Dafina Doberdoli, Claudine Bommer, Agim Begzati, Fehim Haliti, Monika Heinzel-Gutenbrunner, Hrvoje Juric

Abstract

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 P11-4 (SAP P11-4) 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-standard-controlled clinical trial. Test Group 1 received SAP P11-4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P11-4 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 P11-4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.

Conflict of interest statement

The authors declare competing interests. C. Bommer is an employee of credentis. M. Heinzel-Gutenbrunner received compensation for the work performed within the clinical study.

Figures

Figure 1
Figure 1
Investigator Assessments of the study patients. (A–D) Visual Analogue Scale for Tactile Assessment. The lines indicate the 10-cm VAS scale ranging from −50 to +50. Negative values indicate a harder and smoother surface, and positive values indicate softer and rougher surface. Top Control Group (blue), middle Test Group 1 (green), bottom Test Group 2 (orange). The mean value is indicated by a vertical line, and the bars indicate the 95% Confidence Interval. (A) Baseline; (B) Day 90; (C) Day 180; (D) Day 360. (E) Bar chart representing the number of answers to the Global Impression of Change questionnaire for Control, Test Group 1 and Test Group 2 on the indicated follow-ups for each answer. The answers are colour coded: Worse (red); A little worse (light red); Unchanged (grey); A little better (light green); Better (green); Very much better (dark green); Missing answers (black).

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