Safety and efficacy of a biomimetic monolayer of permanently bound multiphosphonic acid molecules on dental implants: 3 years post-loading results from a pilot quadruple-blinded randomised controlled trial.
Eur J Oral Implantol
; 10(1): 43-54, 2017.
Article
em En
| MEDLINE
| ID: mdl-28327694
ABSTRACT
PURPOSE:
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 multiphosphonic acid molecules, which mimics the surface of naturally occurring hydroxyapatite. MATERIALS ANDMETHODS:
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 3â months in mandibles and 6â months in maxillae, then loaded with definitive metal-ceramic crowns and followed for 3â years after loading. Outcome measures were crown/implant failures, any complication, radiographic peri-implant marginal bone level changes and marginal bleeding.RESULTS:
Three patients dropped out but all remaining patients were followed up to 3-years post-loading. No implant failed. Complications were reported for three patients, affecting both types of implant in two patients and only SurfLink implant in one patient. No differences for complications between the two implant types was observed (McNemar test, Pâ =â 1, difference in proportionsâ =â -0.04, 95% CI -0.22 to 0.14). No bleeding was observed when a periodontal probe was run in the peri-implant soft tissues around any of the implants, with the exception of three implants affected by peri-implantitis. There were no statistically significant differences in marginal bone level changes between the two groups (at 3â years post-loading Pâ =â 0.86, mean differenceâ =â -0.05; SDâ =â 1.15; 95% CI -0.56 to 0.47).CONCLUSIONS:
Medium-term data (3-years post-loading) of implants with a biomimetic monolayer of permanently bound multiphosphonic acid molecules (SurfLink surface treatment) presented no safety issues. Clinical healing in both control and SurfLink-treated implant groups was uneventful and did not differ significantly. More challenging clinical situations need to be investigated to evaluate the real effectiveness of this surface treatment. Conflict-of-interest statement Marco Esposito and Ivan Dojcinovic declare that they have no conflict of interest, and they acted as consultants for Nano Bridging Molecules (NBM). Sabrina Buchini, Péter Péchy and Björn-Owe Aronsson are employed at NBM. NBM, the manufacturer of the SurfLink surface treatment, supported and carefully monitored this trial without interfering with the presentation of its results.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Implantes Dentários
/
Planejamento de Prótese Dentária
/
Materiais Biomiméticos
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Eur J Oral Implantol
Assunto da revista:
ODONTOLOGIA
Ano de publicação:
2017
Tipo de documento:
Article