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

Phase 4
Completed
Conditions
Dehiscent Type of Alveolar Bone Defect
One Stage Bone Augmentation
Registration Number
NCT00835432
Lead Sponsor
Charite University, Berlin, Germany
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • alveolar ridge deficiences after tooth loss
Exclusion Criteria
  • systemic disorders (diabetes mellitus, morbus crown, etc.)
  • pregnancy or lactating period

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Alteration in width of alveolar bone at implant location after augmentation in mm6 months
Secondary Outcome Measures
NameTimeMethod
Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material6 months
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