Methods : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
This is an observational multicenter clinical study, approved by the ethics committee of the Freiburg ethics commission international (feci 010/1833). The study was planned and conducted according to the German medical devices law, the Declaration of Helsinki, good clinical practice, and the reporting is aligned with the STROBE statement. A minimum of 90 to 100 patients were planned to be included. Recruitment was performed in six centers (private practices) in Germany during a recruitment period of 16 months applying the following inclusion and exclusion criteria: Adult male or female patients aged ≥ 18 with one or several teeth missing in maxilla or mandible with sufficient bone at the planned implant sites were enrolled. Subjects with any contraindications included in the instructions for use of the implant system, heavy smokers (> 10 cigarettes or equivalents per day), pregnant, or breastfeeding women were excluded. After socket preservation and major bone augmentations, a period of at least 6 months had to elapse before implant surgery. All patients signed a written informed consent form. The study population consisted of 94 patients with 130 implants.
Conical dental implants with internal conical implant-abutment connections (Conelog Screw-Line implants; Camlog Biotechnologies GmbH, Basel, Switzerland) with diameters of 3.8 mm, 4.3 mm, and 5.0 mm, and lengths of 11 mm and 13 mm, and their corresponding prosthetic components including the PS concept were placed. The implant placement was performed in line with the manufacturer’s instructions for use of the implant system, and the treatment was done according to the study centers’ standards and the patients’ indications and has been described in detail elsewhere [10].
After submerged or transmucosal healing (at least 6 weeks when placed in class I, II, or III bone or 12 weeks in class IV bone), the implants were either restored with a provisional or directly with a definitive prosthesis based on the clinicians’ judgment. Implants were loaded with single crowns or fixed partial denture retained by a maximum of two implants.
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- Abstract : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Introduction : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Introduction : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Methods : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Methods : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Methods : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Results : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Results : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Discussion : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Discussion : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Discussion : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Conclusions : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Availability of data and materials : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter
- Abbreviations : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- References : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- References : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- References : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- References : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- References : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
- Acknowledgements : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to
- Funding : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year
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- About this article : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to
- Table 1 Dropouts over observation time : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational
- Table 2 Demography of study population : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational
- Table 3 Mean crestal bone level changes in mm : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational
- Fig. 1. Study flow-chart: assessments and reason for dropouts. Study visits were done according to standard procedures in the respective study centers. Blue, mandatory visits; gray, optional visits : Clinical and patient-reported outcome of implant
- Fig. 2. Kaplan-Meier cumulative survival rate : Clinical and patient-reported outcome of implant
- Fig. 3. Standardized peri-apical radiographs representing the bone level changes at the implant level: immediately post insertion (a), at loading (abutment/crown placement) (b), and at 5-year post-loading (c) : Clinical and patient-reported outcome of implant
- Fig. 4. Soft tissue parameters at 5-year post-loading. a Plaque index: score 0, no plaque detected; score 1, plaque only recognized by running a probe across the smooth marginal surface of the implant; score 2, plaque seen by the naked eye; score 3, abundance of soft matter. b Sulcus bleeding index: score 0, no bleeding when a periodontal probe was passed along the gingival margin adjacent to the implant; score 1, isolated bleeding spot visible; score 2, blood formed a confluent red line on margin; score 3, heavy or profuse bleeding. c Oral hygiene assessed per patient : Clinical and patient-reported outcome of implant
- Fig. 5. PROMs over 5 years: improvement of satisfaction from loading to study end : Clinical and patient-reported outcome of implant