Full Arch Rehabilitations Through the Contemporary All-on-4 Concept

NCT04769921 | Active Not Recruiting FDA Device

• 1 other identifier: AO4ContempProt
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

It is necessary to generate more evidence on the outcome of contemporary protocols for full-arch rehabilitations supported by implants in immediate function in areas with limited quantity and density bone. This research project aims to investigate the outcome of fixed prosthetic restorations supported by implants in immediate function for full-arch rehabilitation through the All-on-4 concept contemporary protocol, specifically: implant survival and success, prosthetic survival, marginal bone level and marginal bone level changes, soft tissue health parameters (Plaque index, Bleeding index, Pocket depth), incidence of biological and mechanical complications. A prospective cohort study design will be used in the investigation. The sample of this study is estimated to consist in 43 patients rehabilitated with full-arch fixed prosthetic rehabilitations supported by implants in immediate function (All-on-4 concept) with 144 dental implants. The cohort will be evaluated between baseline and 3 years of follow-up.

Conditions

Edentulous Jaw

Keywords

All-on-4; All-on-four; dental implants; TiUltra; Xeal

Outcome Measures

Primary Outcomes (2)

• Prosthetic survival

  Survival of the implant-supported prosthesis at the end of the follow-up period

  annually up to 3 years of follow-up

• Dental implants survival

  Survival of the dental implants at the end of the follow-up period

  annually up to 3 years of follow-up

Secondary Outcomes (4)

• Marginal bone loss

  1-, 2- and 3-years

• Plaque index

  1-, 2- and 3-years

• Bleeding index

  1-, 2- and 3-years

• Probing pocket depts

  1-, 2- and 3-years

Other Outcomes (2)

• Biological complications

  During the 3 years of follow-up

• Mechanical complications

  During the 3 years of follow-up

Study Arms (1)

All-on-4 TiUltra and Xeal

Patients rehabilitated in the edentulous maxilla or mandible with an implant supported prosthesis through the All-on-4 Concept (2 anterior implants in the axial position and 2 posterior implants inserted with distal tilting). The implants used will be NobelParallel Conical Connection, with TiUltra surface. The abutments used will be Multi-unit abutments of internal connection with Xeal surface. The immediate prosthesis will be a high-density acrylic and 4 titanium cylinders. The definitive prosthesis will be a Titanium infrastructure with acrylic resin artificial gingiva and either acrylic or ceramic crowns.

Device: dental implants and abutments from Nobel Biocare

Interventions

dental implants and abutments from Nobel Biocare DEVICE

The implants will be inserted in an All-on-4 configuration; Abutments will be connected to the implants and serve as support for a full-arch implant-supported restoration.

Also known as: NobelParallel Conical Connection, Multi-unit abutments with Xeal surface

All-on-4 TiUltra and Xeal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of this study consists in individuals eligible for full-arch rehabilitations with dental implants in immediate function through the All-on-4 concept, of both genders, without age restrictions, in any arch.

You may qualify if:

• Patients with enough bone quantity to be rehabilitated through the contemporary All-on-4 protocol using standard implants (7 to 25 mm of length);
• Patients that are interested in performing their follow-up and maintenance program at Maló Clinic);
• Patients that provide written informed consent to participate.

You may not qualify if:

• Patients without enough bone quantity to be rehabilitated with the need of inserting zygomatic implants;
• Patients that exhibit bone graft reconstructions;
• Hindrance to provide written informed consent

Sponsors & Collaborators

• Malo Clinic: lead
• Nobel Biocare: collaborator

Study Sites (1)

Malo Clinic

Lisbon, Lisbon District, 1600-042, Portugal

Location

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Miguel A de Araújo Nobre, PhD

  Malo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: February 19, 2019
• Primary Completion: July 8, 2022
• Study Completion: August 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)