Clinical Trial: Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - Study on 3i Dental Implants

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

Official Title: Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - A Clinical and Histomorphometric Follow-Up Study on 3i Dental Implants

Brief Summary: Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental implants. The total treatment will be done in 2 stages to allow, within the same group, a study of two different approaches. Miniscrews that can be functionally loaded will be provided by 3i with the design and surface textures as wanted by the study sponsor.

Detailed Summary: The department of oral surgery in Ghent has a lot of patients for bilateral sinus lift procedures. The group of patients should have enough bone for installation of 4 dental implants in the area 14-24. In this region 4 implants will be installed and immediate loading with a provisional acrylic (metal reinforced) bridge will be provided. The survival and success of the implants immediate functional loading will be studied (interest point 1). Two different implant surfaces are used in the study to be compared (interest point 2) in relation to peri-implant parameters, radiographical healing, and success criteria at the same time bilateral sinus lifting is performed. One sinus is filled with a mixture of iliac crest bone and Bio-Oss (Geistlich Germany), and the second sinus is filled with calvarial skull bone and Bio-oss. The latter bone combination is appreciated clinically by the surgeons since it leads to a subjectively better implant stability. This, however, remains to be investigated. This study can compare both harvesting techniques and evaluate clinical treatment outcome (interest point 3). Normally, there is a certain waiting time after sinus lifting before dental implants are installed. Recently, however, some literature abstracts indicate that immediate placement of the implants in the sinus lifted bone can be successful. However, this is not done with immediate functional loading. We propose to install in total 6 miniscrews, 2 in each sinus lift area. Four will be loaded immediately and connected rigidly to the other 4 normal sized implants. Actually the immediate loaded bridge will be supported, in total, by 4 normal and 4 miniscrew implants. Four months after loading, the 4 loaded miniscrews are removed with a trephine drill in order to examine soft-tissue healing, bone-implant contact, and bone healing by means of histomorphometry. Since the implants are in cortical bone + sinus lifted bone, it will be possible to examine the given implant surface under i
Sponsor: University Hospital, Ghent

Current Primary Outcome:

  • Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded [ Time Frame: 4 months ]
  • Comparison of sinus lift with autogenous iliac crest bone + Bio-Oss and sinus lift with an autogenous calvarial skull bone + Bio-Oss [ Time Frame: 4 months ]
  • Installation of implants Prevail and Certain in sinus lift area and naturally healed (non-lifted) bone [ Time Frame: 4 months ]
  • Histological comparison between immediately loaded implants in sinus lifted bone versus normal bone [ Time Frame: 4 months ]
  • Histological comparison at various time intervals [ Time Frame: 4 months ]
  • Histologic findings: integration of the graft, amount of new bone formation, survival and success of the implant, and osseointegration of implant [ Time Frame: 4 months ]


Original Primary Outcome:

  • Comparison of 3i dental implants installed simultanuous with sinuslift procedure and immediately loaded
  • Comparison of sinus lift with autogenous illiaca crest bone + bio-oss and sinus lift with autogenous calvarian skull bone + bio-oss
  • Installation of implants Prevail and Certain in sinuslift area and natural healed (non-lifted) bone
  • Histological comparison between immediately loaded implants in sinuslifted bone versus normal bone
  • Histological comparison at various time intervals
  • Histologic findings: integration of the graft, amount of new bone formation, survival and success of the implant, osseointegration of implant


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Ghent

Dates:
Date Received: April 11, 2006
Date Started: September 2007
Date Completion: September 2015
Last Updated: December 4, 2014
Last Verified: December 2014