Abstract
The aim of the present observational medical device performance study was to test whether implants with an intra-operatively conditioned hydrophilic surface can be safely reconstructed when applying an early loading protocol after 21days in partially edentulous posterior mandibles. Partially edentulous patients with missing teeth in the posterior mandible were recruited. Immediately after implant placement, the implant position was indexed using a pickup impression technique. ISQ values were measured after 21days of healing. When ISQ values were ≥70, the implants were directly restored with provisional reconstructions in occlusal contact allowing an early loading protocol. ISQ values were repeated again at 1, 3, and 6months postloading. Clinical parameters (mPLI, mSBI, PPD, DIM, and CAL) were assessed. Standardized periapical radiographs were obtained after surgery, at implant loading and 3 and 6months later. Changes over time were analyzed for statistical significance using the nonparametric method by Brunner & Langer (SAS Proc Mixed). Fifteen partially edentulous patients with healed sites in the posterior mandible received 20 implants. All implants healed uneventfully. At 21days, all implants achieved an ISQ value of ≥70 (mean of 3 measurements) and were reconstructed at this time point with provisionals. ISQ values showed a gradual increase from baseline to 3 and 6months postloading. The assessment of clinical parameters revealed stable tissue integration. The evaluation of the radiographs showed that 3 and 6months after loading the median mesial and distal marginal bone levels had stabilized at the border between the rough surface and the 1-mm machined implant collar. Functional occlusal loading of implants with a hydrophilic, moderately rough endosseal surface 3weeks after placement appears to be a safe and predictable treatment option in healed sites in the posterior mandible without need of bone augmentation procedures.
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