Bone Quality and Quantity Following Guided Bone Regeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Lior Shapira, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01361321
First received: May 18, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.

Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.

The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.


Condition
Alveolar Ridge Augmentation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Volume of the new bone formed after a GBR procedure [ Time Frame: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants. ] [ Designated as safety issue: No ]
    Bone volume obtained following a GBR procedure will be detemined through a comparison of a 3 dimensional analysis of computed tomography images done before and after the GBR procedure.


Secondary Outcome Measures:
  • Bone quality [ Time Frame: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure. ] [ Designated as safety issue: No ]
    The collected bone sample will be subjected to histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae,the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio.


Biospecimen Retention:   Samples Without DNA

Reisdual bone tissue formed while preparing alveolar bone for dental implant (by drilling with a trephine bur)


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients after GBR procedure
The study will comprise of patients who already underwent a routine Guided Bone Regeneration (GBR) procedure in order to augment a bony ridge before dental implant insertion. The patients will be followed up in order to determine bone quality and quantity formed after the usage of routinely used bone substitutes during GBR procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healty over 18 years of age Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been insertd yet

Criteria

Inclusion Criteria:

  1. Healthy men and women over 18 years of age, eligible for signing
  2. Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
  3. Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

  1. Pregnant or nursing women. children or non judgemental patients
  2. Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
  3. Patients with a pathology present near the site of dental implantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361321

Contacts
Contact: Lior Shapira, Professor +972-2-6776126 shapiral@cc.huji.ac.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem,, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Lior Shapira, Professor Department of Periodontology
  More Information

No publications provided

Responsible Party: Lior Shapira, Prof, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01361321     History of Changes
Other Study ID Numbers: bondbone-HMO-CTIL
Study First Received: May 18, 2011
Last Updated: September 9, 2013
Health Authority: Israel:Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
follow up
Guided bone regeneration
Micro computerized tomography
histological examination

ClinicalTrials.gov processed this record on July 22, 2014