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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
  Purpose

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.


Condition Intervention
Tooth Extractions
Device: Straumann Bone Ceramic
Device: Bio-Oss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • implant success and survival rate [ Time Frame: 1 year post implant loading ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: February 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Bio-Oss
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00900718

Locations
United Kingdom
Eastman Dental Institute, University College London
London, United Kingdom, WC1X8LD
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Nikolaos Donos, DDS, MS, PhD Eastman Dental Institute
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00900718     History of Changes
Other Study ID Numbers: CR 03/05
Study First Received: May 11, 2009
Last Updated: July 9, 2013
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014