This trial is active, not recruiting.

Condition dental implants
Sponsor Hadassah Medical Organization
Start date February 2009
End date April 2010
Trial size 10 participants
Trial identifier NCT00878332, sandwich osteotomy-HMO-CTIL


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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 Outcomes

Histologic slide evaluation of the bone on the dental implantation time
time frame: implantation day (four months post bone augmentation)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title "Sandwich Osteotomy" Histologic Evaluation
Principal investigator Nardy Caspi, MD / DMD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.