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.

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Patients
• Intervention / Treatment: Procedure: rehabilitation with fixed full-arch prosthesis

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 28

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this retrospective cohort study, participants were recruited from edentulous patients rehabilitated with fixed full-arch prosthesis on 4 or 6 implants according to the Nobelguide® protocol between Jun 2009 and December 2019 at the Oral Surgery Unit, Policlinico Umberto I, "Sapienza" University of Rome, Italy. No randomization was applied.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A edentulous patients; edentulous patients rehabilitated with fixed full-arch prosthesis on 4 implants	Procedure: rehabilitation with fixed full-arch prosthesis
Group B edentulous patients; edentulous patients rehabilitated with fixed full-arch prosthesis on 6 implants	Procedure: rehabilitation with fixed full-arch prosthesis

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Maria Paola Cristalli, DDS, Sapienza University of Roma

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2009
• Primary Completion (ACTUAL): February 10, 2014
• Study Completion (ACTUAL): February 26, 2019

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (ACTUAL): April 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Surgery; Dental Implants; all on four; flapless implant surgery; full- arch implant prosthesis; immediate Dental Implant Loading; Computer-Assisted; template-guided surgery; all on six; ; tilted implants
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 0000505/26.04.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No