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

Dental Implants Clinical Trial

Official title:

"Sandwich Osteotomy" Histologic Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00878332
• Other study ID #: sandwich osteotomy-HMO-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2009
• Last updated: April 7, 2009
• Start date: February 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Implants

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic slide evaluation of the bone on the dental implantation time		implantation day (four months post bone augmentation)	No