title: Safety and efficacy of a biomimetic monolayer of permanently bound multi-phosphonic acid molecules on dental implants: 1 year post-loading results from a pilot quadruple-blinded randomised controlled trial.
abstract: OBJECTIVE
  To evaluate the safety and clinical efficacy of a novel surface treatment (SurfLink®, Nano Bridging Molecules, Gland, Switzerland) on titanium dental implants. SurfLink consists of a monolayer of permanently bound multi-phosphonic acid molecules, which mimics the surface of naturally occurring hydroxyapatite.
  
  
  METHODS
  Twenty-three patients requiring at least two single dental implants had their sites randomised according to a split-mouth design to receive one titanium grade 4 implant treated with SurfLink and one untreated control implant. Additional SurfLink-treated implants were placed if needed. Implants were submerged for 3 months in mandibles and 6 months in maxillae, were loaded with definitive metal-ceramic crowns, and followed up for 1 year after loading. Outcome measures were crown/implant failures, any complication, radiographic peri-implant marginal bone level changes and marginal bleeding.
  
  
  RESULTS
  One patient dropped out after abutment connection. All remaining patients were followed up to 1 year post-loading. No implant failed and only 1 postoperative complication (pain) occurred, but it may not have been related to the implant treatment. No bleeding was observed when a periodontal probe was used to examine the peri-implant soft tissues around the implants. There were no statistically significant differences in marginal bone level changes between the two groups (P = 0.057, mean difference = -0.27, SE = 0.13; 95% CI -0.55 to 0.01).
  
  
  CONCLUSIONS
  Preliminary short-term data (1 year post-loading) of implants with a biomimetic monolayer of permanently bound multi-phosphonic acid molecules (SurfLink surface treatment) presented no safety issues. Clinical healing in both the control and SurfLink-treated implant group was uneventful and did not differ significantly between groups. More challenging clinical situations need to be investigated to evaluate the real effectiveness of this surface treatment.
authors.forename: Marco
authors.initials: M
authors.lastname: Esposito
authors.forename: Ivan
authors.initials: I
authors.lastname: Dojcinovic
authors.forename: Laurence
authors.initials: L
authors.lastname: Germon
authors.forename: Nicole
authors.initials: N
authors.lastname: Lévy
authors.forename: Richard
authors.initials: R
authors.lastname: Curno
authors.forename: Sabrina
authors.initials: S
authors.lastname: Buchini
authors.forename: Péter
authors.initials: P
authors.lastname: Péchy
authors.forename: Björn-Owe
authors.initials: BO
authors.lastname: Aronsson
mesh_terms: D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000209:etiology / Q000517:prevention & control; D040761:Biomimetic Materials; D016009:Chi-Square Distribution; D003442:Crowns; D015921:Dental Implants / Q000009:adverse effects; D017267:Dental Prosthesis Design; D019094:Dental Prosthesis, Implant-Supported / Q000009:adverse effects; D019232:Dental Restoration Failure; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D016876:Metal Ceramic Alloys; D008875:Middle Aged; D010757:Phosphorous Acids; D010865:Pilot Projects; D012449:Safety; D018709:Statistics, Nonparametric; D013499:Surface Properties; D013997:Time Factors
chemical_list: D015921:Dental Implants; D016876:Metal Ceramic Alloys; D010757:Phosphorous Acids; C570063:phosphonic acid