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

NCT ID: NCT00878332

Last Updated: 2009-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadassah medical center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nardy Caspi, MD / DMD

Role: PRINCIPAL_INVESTIGATOR

Senior Lecturer oral and maxillofacial surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Jensen OT. Alveolar segmental "sandwich" osteotomies for posterior edentulous mandibular sites for dental implants. J Oral Maxillofac Surg. 2006 Mar;64(3):471-5. doi: 10.1016/j.joms.2005.11.030.

Reference Type BACKGROUND
PMID: 16487811 (View on PubMed)

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. doi: 10.1016/j.joms.2005.10.021.

Reference Type BACKGROUND
PMID: 16413903 (View on PubMed)

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. doi: 10.1016/s0266-4356(98)90713-6.

Reference Type BACKGROUND
PMID: 9762457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18092449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16274157 (View on PubMed)

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. doi: 10.1016/j.joms.2006.02.006. No abstract available.

Reference Type BACKGROUND
PMID: 16916686 (View on PubMed)

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. doi: 10.1016/s0278-2391(99)90883-2. No abstract available.

Reference Type BACKGROUND
PMID: 10555808 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

sandwich osteotomy-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.