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

• Conditions: Dental Implants

• Registration Number: NCT00878332
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02
• Status Verified: 2009-03
• Study First Submitted: 2009-04-07
• Study First Submitted QC: 2009-04-07
• Last Update Submitted: 2009-04-07
• Study First Posted: 2009-04-08
• Last Update Posted: 2009-04-08
• Primary Completion: 2010-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histologic slide evaluation of the bone on the dental implantation time	implantation day (four months post bone augmentation)

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel