Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

This study has been withdrawn prior to enrollment.
(Sponsor withdrew funding of study.)
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
William Giannobile, University of Michigan
ClinicalTrials.gov Identifier:
NCT01154868
First received: June 29, 2010
Last updated: December 11, 2015
Last verified: December 2015

June 29, 2010
December 11, 2015
August 2010
February 2011   (final data collection date for primary outcome measure)
horizontal (width) bone gain or loss in millimeters. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154868 on ClinicalTrials.gov Archive Site
  • radiographic bone changes measured using computer tomography [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • percentage of new bone formation in the alveolar bone core biopsies. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dental Implantation
Procedure: Alveolar ridge augmentation
Under local anesthesia, full-thickness mucoperiosteal flaps will be elevated, followed by degranulation, and collection of all clinical measurements. Crestal and vertical releasing cuts will be performed using diamond-coated discs on the edentulous ridge in need of augmentation. A sequence of bone chisels and osteotomes will be used to split the alveolar ridge in half until a desirable width for implant placement is achieved. Healos® will then be inserted between both osseous plates. Fixation screws will be used as needed to stabilize the expanded alveolar ridge. Collagen barrier membranes (Ossix Plus) will be used to cover the osseous wound. Flaps will be approximated to achieve primary wound closure.
Other Name: Healos
Healos
Intervention: Procedure: Alveolar ridge augmentation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 21 and older
  • 2-4 ADJACENT maxillary front teeth missing
  • require ridge augmentation and dental implant
  • nonsmoker for at least 6 months
  • willing to follow oral hygiene instruction and other study instruction
  • able to read, understand and sign informed consent

Exclusion Criteria:

  • Residual upper jaw bone equal to or narrower than 3mm.
  • Insufficient gum tissue to obtain wound closure after surgery.
  • Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
  • A history of head & neck radiation treatment due to certain medical conditions.
  • Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug
  • Pregnancy or become pregnant during the length of the study
  • Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01154868
HUM00035937
No
Not Provided
Not Provided
William Giannobile, University of Michigan
William Giannobile
Johnson & Johnson
Principal Investigator: William Giannobile, DDS, DMedSc University of Michigan
University of Michigan
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP