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

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
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, see Learn About Clinical Studies.

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:
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 October 20, 2014