NCT02405169

Brief Summary

The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants. Secondary objective

  • overall survival rate
  • soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years
  • prosthetic survival rates including screw or abutment loosening, framework or veneer fractures

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

10.8 years

First QC Date

March 16, 2015

Last Update Submit

February 1, 2025

Conditions

Edentulous Maxilla

Keywords

Implantologyoral surgerybone level changesmarginal bone level

Outcome Measures

Primary Outcomes (3)

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

    1 year

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

    3 year

  • Marginal bone resorption in millimeter from the 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 -4 implants-

EXPERIMENTAL

Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with four with titanium Cad/Cam framework.

Device: 4 vs 6 implant treatment in the maxilla

Control -6 implants-

ACTIVE COMPARATOR

Evaluate marginal bone level (MBL) changes at implants that are placed in total edentulous patient when they are treated with six with titanium Cad/Cam framework

Device: 4 vs 6 implant treatment in the maxilla

Interventions

4 vs 6 implant treatment in the maxillaDEVICE
Also known as: Astratech TX implant , Densply Implant (company name)
Control -6 implants-Test -4 implants-

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years;
  • edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
  • willingness to comply with all study requirements and to sign the IC;
  • have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.

You may not qualify if:

  • bone defects associated with severe knife-edge ridges;
  • bone defects resulting from tumor resection;
  • tobacco abuse (\> 10 cigarettes/day);
  • severe kidney 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franci Institute

Padua, 35121, Italy

Location

Related Publications (1)

  • Toia M, Moreira CS, Dias DR, Corra E, Ravida A, Cecchinato D. Fixed Full-Arch Maxillary Prostheses Supported by Four Versus Six Implants: 5-Year Results of a Multicenter Randomized Clinical Trial. Clin Oral Implants Res. 2025 Mar;36(3):298-313. doi: 10.1111/clr.14383. Epub 2024 Nov 24.

    PMID: 39581887DERIVED

Study Officials

  • Denis Cecchinato, DDS

    Franci Institute

    STUDY DIRECTOR

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
Four versus six endosseous implants to be used in the rehabilitation of totally edentulous patient in the maxilla with titanium milled framework: a randomized, controlled clinical trial.

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 1, 2015

Study Start

December 1, 2013

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations

IT(1)