Complete edentulism (loss of all teeth in one or both jaws) requiring oral rehabilitation with fixed full-arch implant-supported restorations
Conditions
Interventions
Group 1: Retrospective analysis of all patients which received an implant-supported, full-arch restoration
Sponsors
Charité- Universitätsmedizin Berlin Charité Centrum 3 für Zahn- Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient received a full-arch implant-supported prosthesis. Patient shows good oral hygiene and compliance (reliable attendance and cooperation)
Exclusion criteria
Exclusion criteria: Smoking >10 cigarettes/day. Current or previous intake of bisphosphonates, RANKL inhibitors (denosumab), or other medication affecting bone metabolism (e.g., systemic corticosteroids). Pregnancy. Alcohol or drug dependence. Infectious diseases (e.g., hepatitis, HIV, AIDS). Severe, uncontrolled diabetes mellitus. Need for major bone augmentation procedures before implant placement to enable prosthetically correct implant positioning (e.g., lateral/external sinus lift). Untreated acute periodontitis. Clinical signs of bruxism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (WHAT): 1. Implant survival (implant in situ; event = implant loss/explantation) 2. Occurrence of biological, technical, and aesthetic complications (e.g., peri-implantitis/mucositis, screw loosening, fracture/chipping of the superstructure, aesthetic deficiencies) as documented in the clinical records. Time points (WHEN): T0 (index time point): Delivery/insertion of the fixed full-arch superstructure (i.e., prosthetic restoration), according to the medical record. T_follow-up: all documented follow-up visits within the observation period. T_last: last documented follow-up visit (variable per patient; retrospective). Assessment (HOW): Retrospective review of patient records/clinical documentation (clinical findings, repairs/emergency visits, surgical/prosthetic reports) as well as available clinical photographs, models, and radiographs (if available), using the CRF module . | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction (functionality, phonetics/speech, aesthetic satisfaction, cleanability/maintenance). WHEN: At the time of data collection/follow-up as documented (T_last or the time point at which the VAS was administered). HOW: Visual analogue scale (VAS); if no validated, published questionnaire is used: “VAS/items developed specifically for this study.” | — |
Countries
Germany
Contacts
Public ContactStefano Pieralli
Charité- Universitätsmedizin Berlin Charité Centrum 3 für Zahn- Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Outcome results
None listed