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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00318487
First received: April 11, 2006
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Mouth, Edentulous
Procedure: Bilateral sinus augmentation with immediately loaded dental implants

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - A Clinical and Histomorphometric Follow-Up Study on 3i Dental Implants

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Installation of implants Prevail and Certain in sinus lift area and naturally healed (non-lifted) bone [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Histological comparison between immediately loaded implants in sinus lifted bone versus normal bone [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Histological comparison at various time intervals [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral sinus augmentation Procedure: Bilateral sinus augmentation with immediately loaded dental implants
Bilateral sinus augmentation with immediately loaded dental implants will be used.

Detailed Description:

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 immediate loading in both bone conditions (interest point 4). Immediately after removing the miniscrews, they are replaced by the normal sized implants. One side will be randomly assigned for immediate non-functional loading, the other side will be assigned to a non-loaded condition. With this latter design we can mimic the partial sinus lift condition as it is often done 4 months after sinus lifting - the classical procedure. At the time of exposing the implants of the 2-stage procedure, the miniscrews are removed. This gives us an idea of bone healing of an implant installed 4 months after sinus lifting and kept additionally unloaded for 4 months. This gives us histology of immediately loaded implants in healed sinus lifted bone (interest point 5).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers with a full removable denture in the maxilla.
  • Subjects must have enough bone to install 4 dental implants in region 14 to 24 and are in need of a sinus lifting procedure in the posterior mandible (region 18-15 + 25-28).

Exclusion Criteria:

  • Patients with compromised healing capacities such as cancer patients and diabetes patients.
  • Smokers are excluded when smoking > 12 cigarettes per day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318487

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00318487     History of Changes
Other Study ID Numbers: 2006/126
Study First Received: April 11, 2006
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Dental implants

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 25, 2014