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OpenTrials
Completed

NCT Number: NCT00835432

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

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.

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Key information

Conditions

Dehiscent Type of Alveolar Bone Defect One Stage Bone Augmentation

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • alveolar ridge deficiences after tooth loss

Exclusion criteria

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

Treatment and study plan

Ossix

Device

Test group

Other names: cross-linked collagen membrane barrier

Biogide

Device

controls

Other names: non cross-linked collagen membrane barrier

Primary outcomes

  1. Alteration in width of alveolar bone at implant location after augmentation in mm

    Time frame: 6 months

Secondary outcomes

  1. Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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 .

Acronym: BCP+Collagen

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 3, 2009
Registry last updated
Feb 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.