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Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes (BCP+Collagen)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835432
First Posted: February 3, 2009
Last Update Posted: February 3, 2009
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.
Information provided by:
Charite University, Berlin, Germany
  Purpose

Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced areas by applying principles of guided bone regeneration (GBR) subsequently to implant installation.

Ossix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute. Clinical measurements and impressions from the sites of interest are to be taken at the stage of augmentation and 6 months after. At six months re-entry non-standardized biopsies from augmented sites will be taken to determine newly grown tissue in quality and quantity.

Due to different degradation characteristics of the two collagen membranes used as barrier, amount of newly formed mineralized tissue is suspected to vary in tests and controls, respectively.


Condition Intervention Phase
Dehiscent Type of Alveolar Bone Defect One Stage Bone Augmentation Device: Ossix Device: Biogide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Clinical, Morphometric and Histological Study on Augmentation Using BoneCeramic as Bone Substitute in Combination With Either Cross-Linked or Non Cross-Linked Collagen Membrane in Dehiscent Type of Defects .

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Alteration in width of alveolar bone at implant location after augmentation in mm [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material [ Time Frame: 6 months ]

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Ossix
    Test group
    Other Name: cross-linked collagen membrane barrier
    Device: Biogide
    controls
    Other Name: non cross-linked collagen membrane barrier
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • alveolar ridge deficiences after tooth loss

Exclusion Criteria:

  • systemic disorders (diabetes mellitus, morbus crown, etc.)
  • pregnancy or lactating period
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00835432


Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Anton Friedmann, Dr., PhD Department of Periodontology Charité Center3 CBF, Assmannshauser Str. 4-6, 14197 Berlin, Germany
  More Information

Responsible Party: Dr. Anton Friedmann, Department of Periodontology, Charité Center 3, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00835432     History of Changes
Other Study ID Numbers: EA/2/054
First Submitted: February 2, 2009
First Posted: February 3, 2009
Last Update Posted: February 3, 2009
Last Verified: February 2009

Keywords provided by Charite University, Berlin, Germany:
Lateral augmentation
GBR
BoneCeramic
collagen membrane
histomorphometry
morphometry
reentry
biopsy