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Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

This study has been withdrawn prior to enrollment.
(Sponsor withdrew funding of study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154868
First Posted: July 1, 2010
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
William Giannobile, University of Michigan
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Further study details as provided by William Giannobile, University of Michigan:

Primary Outcome Measures:
  • horizontal (width) bone gain or loss in millimeters. [ Time Frame: 18 weeks ]

Secondary Outcome Measures:
  • radiographic bone changes measured using computer tomography [ Time Frame: 18 weeks ]
  • percentage of new bone formation in the alveolar bone core biopsies. [ Time Frame: 18 weeks ]

Enrollment: 0
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154868


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

Publications:
Engler WO, Ramfjord SP, Hiniker JJ. Healing following simple gingivectomy. A tritiated thymidine radioautographic study. I. Epithelialization. J Periodontol. 1966 Jul-Aug;37(4):298-308.
Ramfjord SP, Engler WO, Hiniker JJ. A radioautographic study of healing following simple gingivectomy. II. The connective tissue. J Periodontol. 1966 May-Jun;37(3):179-89.
HURLEY LA, STINCHFIELD FE, BASSETT AL, LYON WH. The role of soft tissues in osteogenesis. An experimental study of canine spine fusions. J Bone Joint Surg Am. 1959 Oct;41-A:1243-54.
MURRAY G, HOLDEN R, ROSCHLAU W. Experimental and clinical study of new growth of bone in a cavity. Am J Surg. 1957 Mar;93(3):385-7.
Buser DA, Tonetti M. Clinical trials on implants in regenerated bone. Ann Periodontol. 1997 Mar;2(1):329-42. Review.
Scipioni A, Calesini G, Micarelli C, Coppè S, Scipioni L. Morphogenic bone splitting: description of an original technique and its application in esthetically significant areas. Int J Prosthodont. 2008 Sep-Oct;21(5):389-97.
Simion M, Baldoni M, Zaffe D. Jawbone enlargement using immediate implant placement associated with a split-crest technique and guided tissue regeneration. Int J Periodontics Restorative Dent. 1992;12(6):462-73.
Engelke WG, Diederichs CG, Jacobs HG, Deckwer I. Alveolar reconstruction with splitting osteotomy and microfixation of implants. Int J Oral Maxillofac Implants. 1997 May-Jun;12(3):310-8.
Coatoam GW, Mariotti A. The segmental ridge-split procedure. J Periodontol. 2003 May;74(5):757-70.
Basa S, Varol A, Turker N. Alternative bone expansion technique for immediate placement of implants in the edentulous posterior mandibular ridge: a clinical report. Int J Oral Maxillofac Implants. 2004 Jul-Aug;19(4):554-8.
Neen D, Noyes D, Shaw M, Gwilym S, Fairlie N, Birch N. Healos and bone marrow aspirate used for lumbar spine fusion: a case controlled study comparing healos with autograft. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E636-40.

Responsible Party: William Giannobile, William Giannobile, D.D.S., D.Med.Sc., University of Michigan
ClinicalTrials.gov Identifier: NCT01154868     History of Changes
Other Study ID Numbers: HUM00035937
First Submitted: June 29, 2010
First Posted: July 1, 2010
Last Update Posted: December 14, 2015
Last Verified: December 2015


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