2 Materials & Methods

1 ObjectiveClinical evaluation of the tooth whitening effect of Curolox™ Whitening, which is a non-oxidising paint-on tooth whitening system based on the combination of a self-assembling peptide (P11-4) matrix and hydroxyapatite particles. The colour changes were assessed by VITA EasyShade.

Claudine Bommer1, Dominikus A. Lysek1, Michael Hug1, Karl-Heinz Kunzelmann2, Hans-Peter Flessa31credentis ag, Windisch/Switzerland; 2University of Munich, Munich/Germany; 3private practice, Holzkirchen/Germany

contact: cb@credentis.com

3 Results• The overall tooth colour change (E) over one week

was ΔE=4.0 (95%CI: 3.6–4.3) at D1 and ΔE=4.9 (95%CI: 4.5–5.3) at D7 and thus clearly of a visibly perceptible magnitude (i.e. ΔE≥3.0; figure 1/2, table 2).

• After D1 and D7, a statistically significant average lightness increase (L) (p<0.001) of ΔL=2.4 (95%CI: 1.9–2.8) respectively ΔL=1.7 (95%CI: 1.1–2.3) compared to the baseline was observed over the 240 study teeth (figure 1, table 2/3).

• The yellow-blue component (b) shifted towards blue by Δb=-0.8 (95%CI: -0.4 to -1.1) on D7 (p<0.001) (figure 1, table 2/3).

• The whitening effect remained stable for 30 days (ΔE=4.8 (95%CI: 4.4–5.3); ΔL=3.6 (95%CI: 3.1–4.1); Δb=0.9 (95%CI: 0.6–1.2)) (figure 1).

3 Results (Continuation) – Figures & Tables

4 ConclusionsCurolox™ Whitening presents a novel non-oxidising tooth whitening agent, which demonstrates a fast, visible and long-term whitening effect when used for a daily 7-day regimen.

Tooth-Whitening Effect of a Curolox™-Technology-based Investigational Product

A: 40 subjects (240 teeth) with at least one maxillary canine or incisor (erosion-, restoration and caries-free) showing a tooth colour of A3 or darker measured by Vita EasyShade were enrolled in this proof-of-concept study (approved by ethics committee; table 1).

B: The non-oxidising investigational whitening product Curolox™ Whitening (self-assembling-peptide P11-4; hydroxyapatite particles (Cafos Dente)) was once applied via a tray for 5min within the dental office (D0), then daily by self-application with a sonic tooth brush for one week (D1-D7) after normal teeth cleaning in the evening.

D: ANOVA indicated a statistically significant difference in the L- (F3,956=11.98; p<0.001) and b-parameter (F3,956 =3.89; p<0.01). A two-tailed paired Student’s t-test was used as post-hoc test and the multiple testing problem was compensated with Bonferroni-correction.

Table 3: Results of lightness parameter (L) and yellow-blue component (b) for baseline and 1, 7 and 30 days after treatment (n=240).

Table 2: Change of lightness (L) and yellow-blue (b) parameter, and tooth colour (E) from baseline to 1, 7 and 30 days after treatment (n=240; ΔL>0: brightening of tooth; Δb<0: decrease in the intensity of the yellow colour; CI: confidence interval; LL: lower limit; HL: higher limit). No change in the red-green component (a) was observed.

Figure 1: Change of lightness (L) and yellow-blue (b) parameter, and tooth colour (E) from baseline to 1, 7 and 30 days after treatment (n=240; box: mean, whiskers: standard deviation, white bullet: median; E=(ΔL2+ Δa2 + Δb2)½). Note: no change in the red-green component (a) was observed.

Table 1: Study population and baseline colour of study teeth (arranged from B1 (brightest) to C4 (darkest); VITA classical A1-D4 colour scale).

C: L*a*b*-colour components were measurement in triplicates with Vita EasyShadeat baseline (D0) (after polishing with a prophypaste), D1, D7 and D30.

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Figure 2: Mean change of tooth colour ΔE from baseline to day 7 versus tooth colour at baseline (n=240; transparent columns where number of teeth ≤ 8).