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

NCT ID: NCT00835432

Last Updated: 2009-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Dehiscent Type of Alveolar Bone Defect One Stage Bone Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Ossix

Test group

Intervention Type DEVICE

Biogide

controls

Intervention Type DEVICE

Other Intervention Names

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cross-linked collagen membrane barrier non cross-linked collagen membrane barrier

Eligibility Criteria

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Inclusion Criteria

* alveolar ridge deficiences after tooth loss

Exclusion Criteria

* systemic disorders (diabetes mellitus, morbus crown, etc.)
* pregnancy or lactating period
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Department of Periodontology, Charité Center 3, Berlin, Germany

Principal Investigators

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Anton Friedmann, Dr., PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology Charité Center3 CBF, Assmannshauser Str. 4-6, 14197 Berlin, Germany

Other Identifiers

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EA/2/054

Identifier Type: -

Identifier Source: org_study_id

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