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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT00835432
• Collaborator: (none)
• Enrollment: 40
• Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dehiscent Type of Alveolar Bone Defect; One Stage Bone Augmentation	Device: Ossix; Device: Biogide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• 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 .
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Alteration in width of alveolar bone at implant location after augmentation in mm [6 months]

Secondary Outcome Measures

1. Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• alveolar ridge deficiences after tooth loss

Exclusion Criteria:

• systemic disorders (diabetes mellitus, morbus crown, etc.)

• pregnancy or lactating period

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00835432
• Other Study ID Numbers: EA/2/054
• First Posted: Feb 3, 2009
• Last Update Posted: Feb 3, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Lateral augmentation; GBR; BoneCeramic; collagen membrane; histomorphometry; morphometry; reentry; biopsy

Study Results

No Results Posted as of Feb 3, 2009