Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

Study Overview
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Brief Summary
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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.

Detailed Description
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Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

Official Title
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Immediate Fixed Full-arch Rehabilitation of Edentulous Jaws on 4 or 6 Implants According to the Nobelguide® Protocol: a Retrospective Study on Clinical and Radiographic Outcomes up to 10 Years of Follow-up.

Conditions
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Edentulous Patients

Intervention / Treatment
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* Procedure: rehabilitation with fixed full-arch prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Mandibles or maxillae edentulous or with hopeless teeth; Patient's request of fixed implant restorations Patients in general good health (ASA-1/ASA-2) Exclusion Criteria Compromised systemic conditions; Head/neck irradiation or chemotherapy within 2 years; Bisphosphonate therapy; Metabolic bone diseases; Insufficient bone volume; Mouth opening less than 50 mm inadequate to place surgical instrumentations. History of periodontitis or smoking habit were not considered exclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A edentulous patients<br>edentulous patients rehabilitated with fixed full-arch prosthesis on 4 implants | Procedure: rehabilitation with fixed full-arch prosthesis<br> <br> |
| Group B edentulous patients<br>edentulous patients rehabilitated with fixed full-arch prosthesis on 6 implants | Procedure: rehabilitation with fixed full-arch prosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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full- arch implant prosthesis, flapless implant surgery, immediate Dental Implant Loading, Surgery, Computer-Assisted, Dental Implants, template-guided surgery, all on four, all on six, ; tilted implants