Clinical performance of self-assembling peptide P₁₁ -4 in the treatment of initial proximal carious lesions: A...

The aim of the present study was to investigate the clinical performance of self-assembling peptide P₁₁ -4 on non-cavitated initial proximal carious lesions 12 months after treatment.

Twenty-six patients, aged between 18 and 65 years, with 35 carious lesions were included in this practice-based, uncontrolled, prospective case series. The opacity and size of the proximal lesions were evaluated visually at baseline and at day 360 using standardized single-tooth or bite-wing and digital-subtraction radiography. Pairwise evaluation of images was carried out in a randomized and blinded manner with respect to the time point.

Twelve months after treatment of the proximal carious lesions, the visual evaluation showed a predominant shift toward regression of the initial lesions. Radiographic assessment yielded regression of the caries in 17 of 28 cases; four of 28 were regarded as unchanged, and seven of 28 lesions showed progression of the carious lesion. Combined assessment of clinical radiographs and digital subtraction radiographs confirmed the radiographic assessment, with 20 of 28 lesions showing total or partial regression, four unchanged, and four progressing.

Radiographic and digital subtraction analyses suggest that initial proximal carious lesions can regress after treatment with P₁₁ -4, but additional factors might influence the overall treatment outcome.