Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

Edentulous Patients Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307029
• Other study ID #: 0000505/26.04.2021
• Status: Completed
• Start date: February 20, 2009
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 26, 2019
• Est. primary completion date: February 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Patients
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• rehabilitation with fixed full-arch prosthesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.