Straumann Bone Ceramic Versus BioOss in Sinus Elevation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00900822
First received: May 11, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Jaw, Edentulous, Partially
Alveolar Bone Loss
Device: Straumann Bone Ceramic
Device: BioOss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Histologically Measured Bone to Implant Contact (BIC) [ Time Frame: 9 months after implant placement ] [ Designated as safety issue: No ]
    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:
  • Implant Survival Rate [ Time Frame: 12 months after loading the implant ] [ Designated as safety issue: No ]
    The percentage of implants remaining in the jaw.

  • Implant Success Rate [ Time Frame: 12 months after loading the implant ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00900822

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

Publications:
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00900822     History of Changes
Other Study ID Numbers: CR 02/05
Study First Received: May 11, 2009
Results First Received: June 6, 2012
Last Updated: July 31, 2012
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on August 26, 2014