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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:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00835432
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 25, 2014