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

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Charité University Medicine Berlin

Status and phase

Completed
Phase 4

Conditions

One Stage Bone Augmentation
Dehiscent Type of Alveolar Bone Defect

Treatments

Device: Ossix
Device: Biogide

Study type

Interventional

Funder types

Other

Identifiers

NCT00835432
EA/2/054

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • alveolar ridge deficiences after tooth loss

Exclusion criteria

  • systemic disorders (diabetes mellitus, morbus crown, etc.)
  • pregnancy or lactating period

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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