Straumann Bone Ceramic Versus BioOss in Sinus Elevation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900822
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : August 31, 2012
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
Institut Straumann AG

Brief Summary:
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Alveolar Bone Loss Device: Straumann Bone Ceramic Device: BioOss Not Applicable

Detailed Description:

Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. The bone grafting materials will be placed into the sinus cavity,(a routine procedure), one material randomly at each side and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated histologically. The site is evaluated every 12 months for 3 years in regards to clinical measurements. The study hypothesis is that the SBC is not worse than BioOss.

Study design: Prospective, randomized, open, controlled, single center, split mouth

Study population: 11 male and female patients at an age of between 18 and 80 years, affected by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited in the study and treated by means of maxillary sinus floor augmentation and delayed implant placement.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Straumann Bone Ceramic
StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures
Device: Straumann Bone Ceramic
Granules applied once during surgery

Active Comparator: BioOss
BioOss is used as a bone grafting material in sinus augmentation procedure
Device: BioOss
Granules that are applied once during surgery

Primary Outcome Measures :
  1. Histologically Measured Bone to Implant Contact (BIC) [ Time Frame: 9 months after implant placement ]
    Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone

Secondary Outcome Measures :
  1. Implant Survival Rate [ Time Frame: 12 months after loading the implant ]
    The percentage of implants remaining in the jaw.

  2. Implant Success Rate [ Time Frame: 12 months after loading the implant ]
    Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females, 18 years to 80 years of age
  • The patients are at least partly edentulous in the both maxillary regions corresponding to the sinuses.
  • A dental implant procedure is foreseen in both maxilla regions corresponding to maxillary sinuses.
  • Patients must be expected to present a bilateral bone defect in the sinus area, which both need a sinus floor augmentation to place one or more dental implants each.
  • Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of each of the maxillary sinuses shall be
  • less than 5 mm and at least 2 mm, as measured by Scanora - tomography Scans in the deepest floor of the sinus
  • residual alveolar crest width should be at least in average more than 4mm as measured by Scanora - tomography scans
  • Patients must be committed to the study and must sign informed consent.
  • Oral hygiene Index less than 25%

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure or planned treatment
  • Current pregnancy at the time of recruitment
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Alcoholism or chronically drug abuse causing systemic compromize
  • Patients who smoke more than 10 cigarettes per day
  • Medication which interferes with bone formation
  • 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
  • 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
  • Previous GBR (bone graft) or dental implant treatment in the posterior segments of the upper maxilla (foreseen implant site)
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
  • Existing teeth in the residual dentition with untreated endodontic problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900822

Dr Mats Hallman
Gävle, Sweden, 80187
Sponsors and Collaborators
Institut Straumann AG
Principal Investigator: Mats Hallman, DDS, PhD Clinic for oral maxillofacial surgery, Gävle hospital, Sweden

Publications of Results:
Responsible Party: Institut Straumann AG Identifier: NCT00900822     History of Changes
Other Study ID Numbers: CR 02/05
First Posted: May 13, 2009    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Straumann AG:
bone grafting
sinus elevation
sinus augmentation

Additional relevant MeSH terms:
Jaw, Edentulous
Alveolar Bone Loss
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases
Bone Resorption
Bone Diseases
Periodontal Atrophy
Periodontal Diseases