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The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.
Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A edentulous patients | edentulous patients rehabilitated with fixed full-arch prosthesis on 4 implants |
| |
| Group B edentulous patients | edentulous patients rehabilitated with fixed full-arch prosthesis on 6 implants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rehabilitation with fixed full-arch prosthesis | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant marginal bone loss (MBL) | difference in marginal bone level from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up measured in millimeters/years on periapical radiographs. Periapical radiographs of each implant were taken every year using the parallel long-cone technique and a standardized film holder (Rinn Centratore XCP Evolution 2003, Dentsply, Rome, Italy). | from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique. |
| Prosthetic complications | included detachment/incisal and occlusal wear/fracture/chipping/replacing of denture teeth, fracture of implant, prosthesis or framework, loosening/fracture of abutment or occlusal screw, loosening/fracture of the prosthetic screw | Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years. |
| Biologic complications | inflammation / infection under fixed prosthesis, soft tissue hypertrophy / hyperplasia, soft tissue recession / dehiscence, peri-implant mucositis, peri-implantitis. Modified plaque index (mPI), modified gingival index (mGI), bleeding on probing (BoP), and probing depth (PD). mPI, mGI, BoP, and PD measurements were performed at 6 aspects per implant. mPI was scored as: 0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant; 2 = plaque can be seen by the naked eye; 3 = abundance of soft matter. mGI was scored as: 0 = no bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant; 1 = isolated bleeding spots visible; 2 = blood forms a confluent red line on mucosal margin; 3 = heavy or profuse bleeding. BoP was scored as 0 = absence; 1 = presence; PD was measured in mm. | Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years. |
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Inclusion Criteria
Exclusion Criteria
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In this retrospective cohort study, participants were recruited from edentulous patients rehabilitated with fixed full-arch prosthesis on 4 or 6 implants according to the NobelguideĀ® protocol between Jun 2009 and December 2019 at the Oral Surgery Unit, Policlinico Umberto I, "Sapienza" University of Rome, Italy. No randomization was applied.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Paola Cristalli, DDS | Sapienza University of Roma | Study Director |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |