NCT00878332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 8, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

April 7, 2009

Last Update Submit

April 7, 2009

Conditions

Dental Implants

Keywords

edentulousfixed dental rehabilitationinsufficient bone heightPartially edentulous patientsPatients interested in fixed non removable dental rehabilitation by dental implants.The recipient bone with insufficient bone height for dental implant insertion.Adult patients

Outcome Measures

Primary Outcomes (1)

  • Histologic slide evaluation of the bone on the dental implantation time

    implantation day (four months post bone augmentation)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • age \> 18 years
  • partially edentulous patients
  • insufficient bone height (recipient site)
  • interested in fixed dental rehabilitation using dental implants

You may not qualify if:

  • smoking
  • unbalanced diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (7)

  • 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.

    PMID: 16487811BACKGROUND

  • 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.

    PMID: 16413903BACKGROUND

  • 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.

    PMID: 9762457BACKGROUND

  • 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.

    PMID: 18092449BACKGROUND

  • 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.

    PMID: 16274157BACKGROUND

  • 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.

    PMID: 16916686BACKGROUND

  • 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.

    PMID: 10555808BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histologic slides

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Nardy Caspi, MD / DMD

    Senior Lecturer oral and maxillofacial surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

April 8, 2009

Record last verified: 2009-03

Locations

IL(1)