Bone Quality and Quantity Following Guided Bone Regeneration

NCT01361321 | Completed

• 1 other identifier: bondbone-HMO-CTIL
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Ridge Augmentation

Keywords

follow up; Guided bone regeneration; Micro computerized tomography; histological examination

Outcome Measures

Primary Outcomes (1)

• Volume of the new bone formed after a GBR procedure

  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.

  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.

Secondary Outcomes (1)

• Bone quality

  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.

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Pregnant or nursing women. children or non judgemental patients
• Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
• Patients with a pathology present near the site of dental implantation

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Officials

• Lior Shapira, Professor

  Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 26, 2011
• Study Start: February 1, 2012
• Primary Completion: February 21, 2013
• Study Completion: February 21, 2013
• Last Updated: November 30, 2017

Record last verified: 2013-09

Locations

IL (1)