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Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05307029
Enrollment
28
Registered
2022-04-01
Start date
2009-02-20
Completion date
2019-02-26
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Patients

Keywords

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

Brief summary

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

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

Interventions

PROCEDURErehabilitation with fixed full-arch prosthesis

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant marginal bone loss (MBL)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.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).
Prosthetic complicationsEvery 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.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
Biologic complicationsEvery 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026