Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00900718
First received: May 11, 2009
Last updated: July 9, 2013
Last verified: July 2013

May 11, 2009
July 9, 2013
February 2006
April 2008   (final data collection date for primary outcome measure)
The changes of bone level between baseline and 32 week post-extraction [ Time Frame: baseline and 32 week post-extraction ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900718 on ClinicalTrials.gov Archive Site
implant success and survival rate [ Time Frame: 1 year post implant loading ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation
Comparison of Straumann Bone Ceramic (SBC) and Bio-Oss in Combination With Guided Tissue Regeneration (GTR) for Volume Preservation of Alveolar Ridge After Tooth Extraction: a Randomised, Single Blind, Controlled Clinical Trial

The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of dental implants placed in the augmented socket area and to assess radiographically and clinically changes of peri-implant soft and hard tissues.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Tooth Extractions
  • Device: Straumann Bone Ceramic
    Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
    Other Name: Synthetic Bone Substitute
  • Device: Bio-Oss
    Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.
    Other Name: Xenograft
  • Experimental: Straumann Bone Ceramic
    Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
    Intervention: Device: Straumann Bone Ceramic
  • Active Comparator: Bio-Oss
    Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.
    Intervention: Device: Bio-Oss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must have voluntarily signed the informed consent
  • Males and females, 18 years to 75 years of age
  • Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
  • Patients must be committed to the study and must sign informed consent
  • Patient in good general health as documented by self assessment

Exclusion Criteria:

Systemic exclusion criteria

  • Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
  • Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
  • Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
  • Patient who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily asprin of more than 81 mg.
  • Patient who knowingly has HIV or Hepatitis
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Patient who has undergone administration of any investigational drug within 30 days of study initiation.
  • Alcoholism or chronically drug abuse causing systemic compromisation
  • Patient who is a heavy smoker (>10/cigarettes per day).
  • Patient is suffering from a known psychological disorder
  • Patient has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed

Local exclusion criteria

  • Uncontrolled or untreated periodontal disease
  • Bone defects that excludes implant restoration
  • Patient who has a full mouth plaque level >30 % at the enrolment visit
  • 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 presenting clinical and radiological signs and symptoms of maxillary sinus disease
  • Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00900718
CR 03/05
No
Institut Straumann AG
Institut Straumann AG
Not Provided
Principal Investigator: Nikolaos Donos, DDS, MS, PhD Eastman Dental Institute
Institut Straumann AG
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP