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Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01154868
First received: June 29, 2010
Last updated: January 6, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Implantation
 Procedure: Alveolar ridge augmentation
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • horizontal (width) bone gain or loss in millimeters. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: August 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healos 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154868

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Johnson & Johnson
Investigators
Principal Investigator: William Giannobile, DDS, DMedSc University of Michigan
  More Information

Publications:

Responsible Party: William Giannobile, DDS, DMedSc, University of Michigan
ClinicalTrials.gov Identifier: NCT01154868     History of Changes
Other Study ID Numbers: HUM00035937
Study First Received: June 29, 2010
Last Updated: January 6, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013