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Journal of Oral Science & Rehabilitation No. 4, 2017

1 - y e a r s t u d y o f n o n s u b m e r g e d i m p l a n t s Introduction Flap raising and surgical trauma,1, 2 second re-entry surgeries and application of subgingival abutments3 may lead to both hard- and soft- tissue complications, i.e., crestal bone loss, wound dehiscence and gingival recession. The need for less-invasive protocols may be useful to avoid these complications. The use of nonsubmerged implants may prevent any surgical re-intervention for cover screw exposure and abutment or further prosthetic phases. The use of a flapless technique may reduce the risk of surgical complications and marginal bone loss.4, 5 The type of implant and morphology of the neck may play some critical role in preserving marginal soft and bone tissue. Recently, a new 2-piece nonsubmerged zirco- nium dioxide-blasted, acid-etched titanium implant (Prama, Sweden & Martina, Due Carrare, Italy) was marketed based on the biologically oriented preparation technique (BOPT). This pros- thetic approach entails the creation of an ideal esthetic contour through gingival adaptation of the crown without the need for invasive surgical procedures. The crown is positioned on a previ- ously prepared tooth with no finishing line, allow- ing the possibility of creating a new prosthetic cementoenamel junction and allowing the crown’s gingival margin to be shaped as desired.6 This prosthetic technique was first described in the context of natural tooth-supported restorations,7 but may be applied also to implant rehabilitation. The Prama implant was designed with a 3 mm hyperbolic machined neck that simulates a nat- ural prosthetic abutment without a finishing line. Short-term case reports and case series are beginning to be published in the literature.8, 9 Preliminary investigations have found promising soft- and hard-tissue management using a flap- less technique and indicated that all prosthetic procedures resulted in simpler and easier pro- cedures than with a conventional submerged implant–abutment connection.8–10 The aim of this consecutive prospective cohort study was to evaluate the failure rate and hard- and soft-tissue modifications and param- eters during the first year of placement of non- submerged Prama implants. Materials and methods clinical and radiographic parameters after 1 year for the treatment of patients who required replacement of a single tooth. The study was conducted in a university endodontic clinical department and 2 private dental offices. Patient recruitment was performed from September 2014 to September 2015. Patients were followed up between October 2014 and May 2017 by the same clinical team. All of the patients included in this investigation were treated according to the principles estab- lished by the Declaration of Helsinki of 1975, as revised in 2013.11 Before enrolment, written and verbal information were given by the clinical staff and each patient gave written consent according to the above-mentioned principles. An additional signed informed consent was obtained from all patients stating that they accepted the treatment plan and agreed to cover the costs and follow the maintenance hygiene program. This report was written according to the Strengthening the Reporting of Observational Studies in Epidemiol- ogy (STROBE)12 and respecting the guidelines published by Dodson in 2007.13 The patients were considered eligible for inclusion in the clinical pro- tocol based on the following inclusion criteria: – aged 18–75; – presence of a single failing tooth or a single tooth gap with both neighboring teeth present; – possibility of inclusion in a hygiene recall pro- gram and implant control for at least 1 year; and – smoking less than 10 cigarettes a day. Exclusion criteria were as follows: – medical and/or general contraindications for the surgical procedures (American Society of Anesthesiologists Physical Status ≥ 3); – poor oral hygiene and lack of motivation; – active clinical periodontal disease in the nat- ural dentition determined by a probing pocket depth > 4 mm and bleeding on probing; – smoking more than 10 cigarettes a day; – uncontrolled diabetes mellitus; – systemic or local disease that could compromise postoperative healing and osseointegration; – alcohol and/or drug abuse; – pregnancy or lactation; – malocclusion or other occlusal disorder (bruxism); and – bisphosphonate therapy. S t u d y s e t t i n g a n d p a t i e n t s e l e c t i o n P a t i e n t a l l o c a t i o n The study design was a single-blinded human longitudinal prospective cohort study evaluating The timing of implant placement (immediate, early or delayed according to the third ITI Journal of Oral Science & Rehabilitation Volume 3 | Issue 4/2017 33

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