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

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 .

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00835432

Acronym

BCP+Collagen

Enrollment

Registered

2009-02-03

Start date

2005-10-31

Completion date

2007-01-31

Last updated

2009-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehiscent Type of Alveolar Bone Defect, One Stage Bone Augmentation

Keywords

Lateral augmentation, GBR, BoneCeramic, collagen membrane, histomorphometry, morphometry, reentry, biopsy

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.

Interventions

DEVICEOssix

Test group

DEVICEBiogide

controls

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

* alveolar ridge deficiences after tooth loss

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Alteration in width of alveolar bone at implant location after augmentation in mm	6 months

Secondary

Measure	Time frame
Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026