title: Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial.
abstract: OBJECTIVE
  We previously reported that a rationally designed biomimetic self-assembling peptide, P₁₁-4, nucleated hydroxyapatite de novo and was apparently capable of in situ enamel regeneration following infiltration into caries-like lesions. Our present aim was to determine the safety and potential clinical efficacy of a single application of P₁₁-4 on early enamel lesions.
  
  
  METHODS
  Fifteen healthy adults with Class V 'white spot' lesions received a single application of P₁₁-4. Adverse events and lesion appearances were recorded over 180 days.
  
  
  RESULTS
  Patients treated with P₁₁-4 experienced a total of 11 adverse events during the study, of which two were possibly related to the protocol. Efficacy evaluation suggested that treatment with P₁₁-4 significantly decreased lesion size (p = 0.02) after 30 days and shifted the apparent progression of the lesions from 'arrested/progressing' to 'remineralising' (p <0.001). A highly significant improvement in the global impression of change was recorded at day 30 compared with baseline (p <0.001).
  
  
  CONCLUSIONS
  The results suggest that treatment of early caries lesions with P₁₁-4 is safe, and that a single application is associated with significant enamel regeneration, presumably by promoting mineral deposition within the subsurface tissue.
authors: Restorative Dentistry, Leeds Dental Institute, University of Leeds, Clarendon Way, Leeds, LS2 9LU, UK.
authors: P A
authors: PA
authors: Brunton
authors: R P W
authors: RP
authors: Davies
authors: J L
authors: JL
authors: Burke
authors: A
authors: A
authors: Smith
authors: A
authors: A
authors: Aggeli
authors: S J
authors: SJ
authors: Brookes
authors: J
authors: J
authors: Kirkham
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D040761:Biomimetic Materials / Q000009:adverse effects / Q000627:therapeutic use*; D003731:Dental Caries / Q000628:therapy*; D003743:Dental Enamel / Q000187:drug effects; D003807:Dentin Sensitivity / Q000209:etiology; D018450:Disease Progression; D017886:Durapatite / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D023822:Tissue Engineering / Q000379:methods; D054457:Tissue Scaffolds; D014089:Tooth Remineralization / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009842:Oligopeptides; C000601169:P11-4 peptide; D010455:Peptides; D017886:Durapatite
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