Internal vs. External Connection in Screw-retained Multi-units Bridges With Cad/Cam Milled Co/Cr Framework (ISUS-Atlantis)

NCT02789956 | Active Not Recruiting

• 1 other identifier: IIS-14-083
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate: Primary objective The primary objective of the present study is to evaluate the marginal bone level changes when partially edentulous patients, treated with implants, received a multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an Internal or External connection. Secondary objective

1. 1.Overall survival rate.
2. 2.Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years.
3. 3.Prosthetic survival rates including screw or abutment loosening, framework or veneer fractures.

Conditions

Rehabilitation of Edentulous Area With an Implant Level Set-up

Keywords

Internal connection; Cobalt/Chrome; Cad-cam Framework; marginal bone level

Outcome Measures

Primary Outcomes (3)

• Marginal bone resorption in millimeter from the implant to the bone crest.

  1 year

• Marginal bone resorption in millimeter from the implant to the bone crest.

  3 year

• Marginal bone resorption in millimeter from the implant to the bone crest.

  5 year

Secondary Outcomes (3)

• Fracture of the prosthetic components

  1 year

• Fracture of the prosthetic components

  3 year

• Fracture of the prosthetic components

  5 year

Study Arms (2)

Test: internal connection

EXPERIMENTAL

Evaluate marginal bone level (MBL) changes at implants that are placed semi-edentulous patient when they are treated with implant level Co/cr Cad/Cam framework.

Device: Internal vs. external cad cam co/cr framework

Test: external connection

ACTIVE COMPARATOR

Evaluate marginal bone level (MBL) changes at implants that are placed semi-edentulous patient when they are treated with abutment level Co/cr Cad/Cam framework.

Device: Internal vs. external cad cam co/cr framework

Interventions

Internal vs. external cad cam co/cr framework DEVICE

Also known as: Astratech EV system, Dentsply HI

Test: external connection; Test: internal connection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Willingness to comply with all study requirements and to sign the IC.
• Systemic health.
• Compliance with good oral hygiene.
• Patients with at least 2 teeth to replace in any side of the jaws.

You may not qualify if:

• Patients treated with implant with bone defects associated with severe knife-edge ridges.
• Patients treated with bone defects resulting from tumor resection.
• Tobacco abuse (\> 10 cigarettes/day).
• Severe renal and liver disease.
• History of radiotherapy in the head and neck region.
• Chemotherapy for treatment of malignant tumors at the time of the surgical procedure.
• Uncontrolled diabetes.
• Active periodontal disease involving the residual opposite dentition.
• Mucosal disease, such as lichen planus, in the areas to be treated.
• Poor oral hygiene.
• Non-compliant patients.
• Situations judged inconvenient(by the investigator) for the surgical treatment.

Sponsors & Collaborators

• Institute Franci: lead

Study Sites (1)

Studiotoia Srl

Busto Arsizio, Varese, 21052, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: June 3, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

IT (1)