Histologic Evaluation of Bone Formation After Alveolar Augmentation by "Sandwich Osteotomy" Procedure for Dental Implants Insertion

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Hadassah Medical Organization.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00878332

First received: April 7, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Purpose

The purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place.

Condition
Dental Implants

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	"Sandwich Osteotomy" Histologic Evaluation

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Histologic slide evaluation of the bone on the dental implantation time [ Time Frame: implantation day (four months post bone augmentation) ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Histologic slides

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
partially edentulous patients Adult (post growth period) patients who are interested in fixed dental rehabilitation (non- removable denture) by dental implants. Partially edentulous patients with insufficient bone height for dental implant insertion.

Detailed Description:

Dental implant use for partially edentolous jaw is a predictable procedure with high success rate. However, implantation procedure requires sufficient bone support both vertically and horizontally, and sometimes there is bone defect that requires bone augmentation prior to dental implant insertion.

There are some bone augmentation techniques known and used for this purposes, including: guided bone regeneration (GBR), distraction osteogenesis, split osteotomy, onlay bone graft, and interpositional bone graft.

One of the techniques is the interpositional bone graft using "sandwich osteotomy" technique, in which a cut is made in the bone (one horizontal and two vertical) separating a mobile bone portion which is fixed (using bone plate) in its new "ideal" position. The gap between the moved bone and the remaining bone is filled with xenograft ("bio-oss"). There is no documentation in the literature about histological evaluation of the bone after this well known clinical procedure. Four months after the bone augmentation procedure - the fixating plate is moved out and dental implants inserted. The first bur of the implantation (the smallest in the diameter) will be a trephine from which a histologic slide will be taken for check. The continuous dental implants insertion is the normal protocol for dental implantation (widening the recipient hole with bur, and insertion of the implant), followed by rehabilitation by prosthodontics.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

patients refered to the oral and maxillofacial clinic for bone augmentation (because of insufficient bone height) and fixed rehabilitation using dental implants

Criteria

Inclusion Criteria:

age > 18 years
partially edentulous patients
insufficient bone height (recipient site)
interested in fixed dental rehabilitation using dental implants

Exclusion Criteria:

smoking
unbalanced diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878332

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Nardy Caspi, MD / DMD

Senior Lecturer oral and maxillofacial surgery

More Information

Publications:

Jensen OT. Alveolar segmental "sandwich" osteotomies for posterior edentulous mandibular sites for dental implants. J Oral Maxillofac Surg. 2006 Mar;64(3):471-5.

Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. Erratum in: J Oral Maxillofac Surg. 2006 Jun;64(6):997.

Stellingsma C, Raghoebar GM, Meijer HJ, Batenburg RH. Reconstruction of the extremely resorbed mandible with interposed bone grafts and placement of endosseous implants. A preliminary report on outcome of treatment and patients' satisfaction. Br J Oral Maxillofac Surg. 1998 Aug;36(4):290-5.

Marchetti C, Trasarti S, Corinaldesi G, Felice P. Interpositional bone grafts in the posterior mandibular region: a report on six patients. Int J Periodontics Restorative Dent. 2007 Dec;27(6):547-55.

Yeung R. Surgical management of the partially edentulous atrophic mandibular ridge using a modified sandwich osteotomy: a case report. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):799-803.

Robiony M, Costa F, Politi M. Alveolar sandwich osteotomy of the anterior maxilla. J Oral Maxillofac Surg. 2006 Sep;64(9):1453-4; author reply 1454-5. No abstract available.

Politi M, Robiony M. Localized alveolar sandwich osteotomy for vertical augmentation of the anterior maxilla. J Oral Maxillofac Surg. 1999 Nov;57(11):1380-2. No abstract available.

Responsible Party:	Nardy Caspi, Hadassah medical center
ClinicalTrials.gov Identifier:	NCT00878332 History of Changes
Other Study ID Numbers:	sandwich osteotomy-HMO-CTIL
Study First Received:	April 7, 2009
Last Updated:	April 7, 2009
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

edentulous
fixed dental rehabilitation
insufficient bone height
Partially edentulous patients

Patients interested in fixed non removable dental rehabilitation by dental implants.
The recipient bone with insufficient bone height for dental implant insertion.
Adult patients

ClinicalTrials.gov processed this record on May 22, 2013

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