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
Patients were scheduled to follow-ups at 6 months, 1-, 2-, 3-, 4-, and 5-year post-loading for the assessment of the study parameter (Fig. 1). Depending on the investigators’ standard post-operative protocol, follow-up appointments were scheduled slightly differently: One center skipped the control visits at 6 months. Additionally, due to the observational character of the study and the patients’ willingness, a flexible scheduling was necessary. Regular oral maintenance care (dental hygiene session) was performed individually for every patient during the entire study period. X-rays were done as usual in the individual centers and photographs were taken. The oral health status was measured by assessing the plaque index and sulcus bleeding index, if routinely performed in the practice. All but one center documented the indices leading to representative results. And the patients filled a questionnaire asking for their satisfaction regarding comfort, appearance, ability to chew, ability to taste, and general satisfaction with their restoration at each visit (PROMs) [18, 24, 25].
The primary outcome was to assess implant survival of the implants 5-year post-loading. Secondary outcomes were changes of the bone level over time, evaluation of peri-implant soft tissue, as well as the evaluation of patients’ related outcome measures.
Prior to study start, all examiners met for calibration of the parameters. Implant survival and complications were documented at each study visit. Changes in crestal bone levels (BLC) were assessed measuring the distance implant shoulder to first visible bone contact (DIB) at the mesial and distal site of an implant on available radiographs, either peri-apical radiographs or orthopantomograms (OPTGs). The radiographs were not standardized throughout the study centers. Non-digital radiographs were digitized by scanning (Epson Perfection V700 Photo). The radiographs were calibrated and analyzed in an image-processing software (ImageJ 1.50i; http://imagej.nih.gov/ij). BLC were calculated as difference between surgery and loading, as well as between loading and 1-, 3-, and 5-year post-loading. Due to the observational study character, radiographs could not be collected systematically and therefore were not available for all patients and time points. The evaluation of soft tissue parameters and patient-related outcome measures regarding functional and esthetic outcome of the dental restorations are described in Figs. 4 and 5 respectively. Adverse events were documented throughout the study.
Serial posts:
- 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
- Author information : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to
- Ethics declarations : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to
- Additional information : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up
- Rights and permissions : Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up
- 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