Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

Completed

• Conditions: Edentulous Patients

• Registration Number: NCT05307029
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2009-02-20
• Primary Completion: 2014-02-10
• Study Completion: 2019-02-26
• Study First Submitted: 2022-01-17
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prosthetic complications	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.	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
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).
Biologic complications	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.	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.