Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

NCT01154868 | Withdrawn Phase 4

• 1 other identifier: HUM00035937
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implantation

Outcome Measures

Primary Outcomes (1)

• horizontal (width) bone gain or loss in millimeters.

  18 weeks

Secondary Outcomes (2)

• radiographic bone changes measured using computer tomography

  18 weeks

• percentage of new bone formation in the alveolar bone core biopsies.

  18 weeks

Study Arms (1)

Healos

OTHER

Procedure: Alveolar ridge augmentation

Interventions

Alveolar ridge augmentation PROCEDURE

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.

Also known as: Healos

Healos

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 21 and older
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Giannobile: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (11)

• 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. doi: 10.1902/jop.1966.37.4.298. No abstract available.

  PMID: 4287364 BACKGROUND

• 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. doi: 10.1902/jop.1966.37.3.179. No abstract available.

  PMID: 4956575 BACKGROUND

• 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. No abstract available.

  PMID: 13852565 BACKGROUND

• 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. doi: 10.1016/0002-9610(57)90827-9. No abstract available.

  PMID: 13403056 BACKGROUND

• Buser DA, Tonetti M. Clinical trials on implants in regenerated bone. Ann Periodontol. 1997 Mar;2(1):329-42. doi: 10.1902/annals.1997.2.1.329.

  PMID: 9151565 BACKGROUND

• Scipioni A, Calesini G, Micarelli C, Coppe 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.

  PMID: 18950058 BACKGROUND

• 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.

  PMID: 1298734 BACKGROUND

• 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.

  PMID: 9197095 BACKGROUND

• Coatoam GW, Mariotti A. The segmental ridge-split procedure. J Periodontol. 2003 May;74(5):757-70. doi: 10.1902/jop.2003.74.5.757.

  PMID: 12816307 BACKGROUND

• 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.

  PMID: 15346753 BACKGROUND

• 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. doi: 10.1097/01.brs.0000232028.97590.12.

  PMID: 16915079 BACKGROUND

MeSH Terms

Interventions

Alveolar Ridge Augmentation; Healos

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• William Giannobile, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: William Giannobile, D.D.S., D.Med.Sc.

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)