Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes (BCP+Collagen)
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.
Dehiscent Type of Alveolar Bone Defect
One Stage Bone Augmentation
|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 .|
- Alteration in width of alveolar bone at implant location after augmentation in mm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835432
|Principal Investigator:||Anton Friedmann, Dr., PhD||Department of Periodontology Charité Center3 CBF, Assmannshauser Str. 4-6, 14197 Berlin, Germany|