Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Dental Implantation Clinical Trial

Official title:

Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01154868
• Other study ID #: HUM00035937
• Status: Withdrawn
• Phase: Phase 4
• First received: June 29, 2010
• Last updated: December 11, 2015
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Implantation

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Giannobile	Johnson & Johnson

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

Buser DA, Tonetti M. Clinical trials on implants in regenerated bone. Ann Periodontol. 1997 Mar;2(1):329-42. Review. — View Citation

Coatoam GW, Mariotti A. The segmental ridge-split procedure. J Periodontol. 2003 May;74(5):757-70. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	horizontal (width) bone gain or loss in millimeters.		18 weeks	No
Secondary	radiographic bone changes measured using computer tomography		18 weeks	No
Secondary	percentage of new bone formation in the alveolar bone core biopsies.		18 weeks	No