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

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. Identifier: NCT00878332
Recruitment Status : Unknown
Verified March 2009 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : April 8, 2009
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease
Dental Implants

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.

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Sandwich Osteotomy" Histologic Evaluation
Study Start Date : February 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2011

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.

Primary Outcome Measures :
  1. Histologic slide evaluation of the bone on the dental implantation time [ Time Frame: implantation day (four months post bone augmentation) ]

Biospecimen Retention:   Samples Without DNA
Histologic slides

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT00878332

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Nardy Caspi, MD / DMD Senior Lecturer oral and maxillofacial surgery

Responsible Party: Nardy Caspi, Hadassah medical center Identifier: NCT00878332     History of Changes
Other Study ID Numbers: sandwich osteotomy-HMO-CTIL
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: March 2009

Keywords provided by Hadassah Medical Organization:
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