Clinical Trial: 4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam Framework

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework

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

Detailed Summary:

METHODS/PROCEDURES A randomized controlled multi-center clinical study is designed to determine whether a difference exists between the outcome of treatment when Astra tech implants are placed according to a six or a four implants protocol. The investigation will be performed in four centers: three in Italy affiliated to Institute Franci and one affiliated to the Department of Prosthodontics, Faculty of Odontology, Malmö University. In each center the clinician and the examiner will be the same person. The study protocol will be approved by the Regional Human Review Board of Padova General Hospital.

An investigators' meeting will be arranged prior to the starting with the patients' recruitment. Following a screening examination, subjects who will meet the inclusion criteria, will sign the Informed Consent and will be enrolled in the study. The period of patient enrollment will begin on January 1 2013 and ends December 31 2013.

The patients will be randomized with a method based on the use of sealed opaque envelopes. The cases will be assigned to two different treatment groups:

Group A- four implants (Test) Group B- six implants (Control)

Pre-treatment Patient data, medical history, clinical and radiographic examination will be recorded for each patient. Clinical photographs will be taken in frontal, occlusal and lateral projections.

Periodontal, endodontic and open caries lesions will be treated prior to implant installation. All patients will receive careful oral hygiene instructions and training in self-performed

plaque control measure. CT scan computed exams will be carried out. Plaster models and diagnostic wax-up wil
Sponsor: Institute Franci

Current Primary Outcome:

  • Marginal bone resorption in millimeter from the the implant to the bone crest. [ Time Frame: 1 year ]
  • Marginal bone resorption in millimeter from the the implant to the bone crest. [ Time Frame: 3 year ]
  • Marginal bone resorption in millimeter from the the implant to the bone crest. [ Time Frame: 5 year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fracture of the prosthetic components [ Time Frame: 1 year ]
  • Fracture of the prosthetic components [ Time Frame: 3 year ]
  • Fracture of the prosthetic components [ Time Frame: 5 year ]


Original Secondary Outcome: Same as current

Information By: Institute Franci

Dates:
Date Received: March 16, 2015
Date Started: December 2013
Date Completion: February 2021
Last Updated: March 2, 2017
Last Verified: March 2017