Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00901121
First received: May 11, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure.


Condition Intervention
Maxillary Ridge Augmentation
Sinus Lift
Dental Implants
Device: Straumann BoneCeramic
Device: Bio-Oss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maxillary Sinus Grafting With Bio-Oss or Straumann Bone Ceramic Followed by Delayed Placement of Straumann Dental Implants: A Comparative Histomorphometric and Clinical Study

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement. [ Time Frame: 180 to 240 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft. [ Time Frame: 180 to 240 days ] [ Designated as safety issue: No ]
  • Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Clinical evaluation of peri implant soft tissue [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2005
Study Completion Date: March 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BoneCeramic
Straumann BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate - a mixture of 60% hydroxylapatite and of 40% of the beta form of tricalcium phosphate (beta-TCP).
Device: Straumann BoneCeramic
Straumann BoneCeramic (500-1000 microns, 0.5g)
Active Comparator: Bio-Oss
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Device: Bio-Oss
Bio-Oss spongiosa granules, size of particle 0.25-1 mm

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females were at least 18 years of age and not more than 70 years old
  • A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus
  • Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants
  • The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses
  • Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans
  • Patients were committed to the study
  • Patients were healthy at time of surgery

Exclusion Criteria:

  • Medical conditions requiring prolonged use of steroids
  • Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies
  • Haemophilia, bleeding disorders or cumarin therapy
  • History of neoplastic disease requiring the use of chemotherapy
  • History of radiation therapy to the head and neck
  • Patients with history of renal failure or chronic renal diseases
  • Patients affected by chronic liver diseases
  • Patients with severe or uncontrolled metabolic bone disorders
  • Uncontrolled endocrine disorders (including diabetes)
  • Current pregnancy at the time of recruitment
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 90 days period immediately prior to implant surgery on study day 0
  • Alcoholism or chronically drug abuse causing systemic compromisation
  • Immunocompromised patients including patients infected with HIV
  • Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability

Local exclusion criteria

  • Local inflammation, including untreated periodontitis to residual dentition
  • Mucosal diseases such as erosive lichen planus
  • History of local radiation therapy
  • Presence of oral lesions (such as ulceration, malignancy)
  • Severe bruxing or clenching habits
  • Persistent intraoral infection
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Unhealed extraction sites in the upper premolar or molar area
  • Last tooth extraction performed less than 3 months before surgery 1
  • Previous GBR (guided bone regeneration) or dental implant treatment in the lateral-posterior segments of the upper maxilla (foreseen implant site)
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
  • Patients presenting with residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus less than 3 mm and residual alveolar crest width less than 6 mm (measured by the CT scans)
  • The reduction in residual bone height was determined by sinus pneumatization and not by vertical resorption of the residual alveolar crest with increased interarch distance. Patients with increased interarch distance were excluded from the study
  • Existing teeth in the residual dentition with untreated endodontic or cariologic problems
  • Horizontal or vertical augmentation to correct the vertical inter-arch distance or to correct horizontal defects
  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: NCT00901121

Locations
Italy
University of Milan
Milan, Italy, 20142
Private Practice
Milan, Italy, 20124
Private Practice
Naples, Italy, 80429
Private Practice
Naples, Italy, 80121
Private Practice
Pavia, Italy, 27100
Eastman Dental Hospital ASL RMA Roma
Rome, Italy, 00197
Private Practice
Rome, Italy, 00145
Private Practice
Rome, Italy, 00151
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Matteo Chiapasco, Prof University of Milan
  More Information

Publications:
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00901121     History of Changes
Other Study ID Numbers: CR 09/04
Study First Received: May 11, 2009
Last Updated: July 9, 2013
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Institut Straumann AG:
maxillary sinus lift
Histomorphometric evaluation
bone graft
bone augmentation

ClinicalTrials.gov processed this record on August 28, 2014