To investigate the safety and efficacy of Self-Assembling Peptide P11-4 (SAP P11-4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P11-4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P11-4 lesions (test, D90–D0) showed significant WSL size reduction compared to placebo (control, D90–D0; p = 0.008) or FV (control, D180–D90; p = 0.001). Combination of SAP P11-4 and delayed FV after 90 days (test, D180–D0), showed a significant difference compared to FV alone (control D270–D90; p = 0.003). No significant difference on FV efficacy was found when SAP P11-4 was applied 3 months before FV (test D270–D90; control D270–D90, p = 0.70). SAP P11-4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P11-4. SAP P11-4 was found to be a safe and effective WSL treatment.

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BackgroundDental caries develops as a result of the metabolism of carbohydrates by cariogenic bacteria present in a complex biofilm. The present study aimed to examine if bacteria in pooled supragingival plaque samples quantified using a “checkerboard DNA-DNA hybridization” based panel of caries-related bacteria, could reflect the caries experience in a manner similar to saliva samples analysed using a chair-side method in a previous investigation.MethodsA total of 86 mothers and their children aged 4–6 years and 12–16 years old participated. Caries experience (DMFT/dmft; Decayed, Missing and Filled Teeth for permanent and primary teeth) was registered clinically and radiographically. Caries was recorded at the D3 level (caries into dentine). The D/d component was divided into three categories. A pooled supragingival plaque sample per participant was obtained from posterior approximal sites. Analyses of 15 bacterial species were performed using the checkerboard DNA-DNA hybridisation technique.ResultsNo significant relationships were found between the bacterial scores and DMFT/dmft nor D/d groups.ConclusionsUnlike the saliva samples and the chair-side method, interproximal pooled plaque samples analysed using the “checkerboard DNA-DNA hybridization technique” did not reveal any significant relations between the bacterial counts and the caries experience.