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ePaper created 2018-01-31, 10:01:59 | version 1.38.0
| research Day 60 (second stage) After drilling, the sequence of placement of four im- plants by hemi-mandible was randomly planned (us- ing randomization as mentioned). The implants were inserted in healed bone at the sites of the mandibular premolars and molars (P2, P3, P4, M1), with an insertion torque of 30 Ncm or more (Figs. 2a–c). Analysis (eight weeks after implantation) – Histological and histomorphometric analysis of the bone-to-implant contact area (BIC) with linear mea- surements in millimetres: peri-implant mu- cosa (PM), buccal bone crest (BC), lingual bone crest (LC), top of the implant shoulder (IS), bone crest (BC), distance from the im- plant shoulder at buccal bone crest (IS-BC), distance from the implant shoulder at lin- gual bone crest (IS-LC)(Figs. 3a & b). – Primary stability was evaluated by measur- ing the ISQ by Osstell Mentor at the time of placement. – The radiological analysis was performed us- ing a standardized protocol. Human protocol The research protocol called for recruit- ment of subjects among patients referred to the Department of General Dentistry, Univer- sity of Murcia, Spain, during an 18-month period. All those in need of anterior oral re- habilitation that would include single-implant placement were invited to take part in the study, which was overseen by the institu- tional review board. teotome. The manufacturer’s implant placement proto- col for blueSKY implants (bredent medical) was followed. After placement, the site was closed using 4/0 polypro- pylene single sutures. – Postsurgical care: All patients received anti- inflammatory treatment (NSAID), ibuprofen 3 x 400 mg/ day for three days and two chlor hexidine 0.12 % rinses per day for two days. – Implants: Ten blueSKY implants (bredent medical) 3.5–4 mm in diameter and 10–12 mm in length were randomly assigned and placed crestally in the pre- molar zone (P1 or P2) of the maxilla. – Abutments: Ten BioHPP SKY elegance abut- ments (Fig. 4) were connected at the time of im- plant placement (immediate loading). The SKY elegance is a hybrid abutment with a body made of BioHPP moulded directly onto the tita- nium base without a gap. These abutments are used for single-session immediate-restoration treatments, since they combine the prop- erties of a temporary and a definitive abut- ment, i.e. it is not necessary to change the abutment. All crowns were realized using the CEREC system (Sirona, Bensheim, Germany) with IPS Empress CAD CEREC/InLab (Ivoclar Vivadent, Schaan, Liechtenstein) feldspar ceramics. The crowns were cemented with RelyX self-adhesive cement (3M ESPE, Neuss, Germany). All implants were loaded using a platform-switching protocol. Analysis – Radiological analysis: Standardized radio- graphs were taken on the day of placement and at one, three and five months using a one-position paralleling system. The analy- sis was performed with the ImageJ software (Wayne Rasband, NIH, Bethesda, USA). The distances between the platforms and the points of first bone contact were recorded. – ISQ stability analysis: Stability measurements were made on day 0 to assess the primary sta- bility of the implant required for the immedi- ate-loading protocol. An ISQ of 65 was defined as the minimum value needed (Osstell Mentor; Osstell, Göte- borg, Sweden). – Mucogingival analysis and clinical findings: The bleed- ing index was recorded one, three and five months after implant placement by means of a special peri-implant probe. Moreover, any post-insertion loss of peri-implant mucosa or height were recorded. Bleeding on probing (0 = absent, 1 = present) was measured at one, three and five months. The insertion length was measured with a conventional plastic probe by one examiner per examination period and six measurements for each im- plant. The results were presented as means of six mea- surements. Additional criteria for inclusion in the study included sufficient bone height and width to allow the placement of implants with a mini- mum diameter of 4.1 mm and a minimum length of 10 mm and an occlusal pattern that allowed for bilateral stability. All subjects needed to have at least 3 mm of soft tissue (vertically) to allow for the establishment of an adequate biologic width and to reduce bone resorption. Exclusion criteria included severe maxillomandibular skeletal discrepan- cies, non-controlled diabetes, haemophilia, metabolic bone disorders, a history of renal failure or radiation treatment of the head or neck region, ongoing chemo- therapy, pregnancy, drug or alcohol abuse, poor oral hygiene, insufficient bone volume at the recipient site, and the need for bone augmentation prior to implant placement. Fig. 4: SKY elegance abutment. Day 0 (surgical planning and protocol) A full-thickness incision was made with a No. 15c blade, combining an intrasulcular with a crestal incision in the palatal area. A full flap was reflected using a perios- 10 CAD/CAM 1 2018