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 21 days in partially edentulous posterior mandibles.Material and methods:
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 21 days 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 6 months postloading. Clinical parameters (mPLI, mSBI, PPD, DIM, and CAL) were assessed. Standardized periapical radiographs were obtained after surgery, at implant loading and 3 and 6 months later. Changes over time were analyzed for statistical significance using the nonparametric method by Brunner & Langer (SAS Proc Mixed).Results:
Fifteen partially edentulous patients with healed sites in the posterior mandible received 20 implants. All implants healed uneventfully. At 21 days, 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 6 months postloading. The assessment of clinical parameters revealed stable tissue integration. The evaluation of the radiographs showed that 3 and 6 months 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.Conclusion:
Functional occlusal loading of implants with a hydrophilic, moderately rough endosseal surface 3 weeks after placement appears to be a safe and predictable treatment option in healed sites in the posterior mandible without need of bone augmentation procedures.