NCT00835432

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

February 2, 2009

Last Update Submit

February 2, 2009

Conditions

Dehiscent Type of Alveolar Bone DefectOne Stage Bone Augmentation

Keywords

Lateral augmentationGBRBoneCeramiccollagen membranehistomorphometrymorphometryreentrybiopsy

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    6 months

Interventions

OssixDEVICE

Test group

Also known as: cross-linked collagen membrane barrier
BiogideDEVICE

controls

Also known as: non cross-linked collagen membrane barrier

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • alveolar ridge deficiences after tooth loss

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anton Friedmann, Dr., PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

October 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-02