Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement

November 26, 2017 updated by: Hadassah Medical Organization

Bone Quality and Quantity Following Guided Bone Regeneration With Bio-Oss Alone or Combined With BondBone, Prior to Dental Implant Placement

Amongst the consequences of missing teeth are change of appearance and difficulties in mastication and speech. Dental implants in the maxilla or mandible provide a common treatment modality by offering anchorage to fixed or removable fixtures. In many cases, the lack of teeth is accompanied by lack of appropriate bone volume in the desired area for dental implant placement. Possible causes for this lack of sufficient bone volume are varied and include earlier bone atrophy, traumatic tooth extraction and bone resorption due to periodontal disease. In such cases, dental implant placement is preceded by alveolar bone augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in which a bulk of bone substitute is placed in the area which needs more volume before placing a dental implant. The bone substitute is covered with an inert membrane and may provide a scaffold and encourage cells from the patient to reach the area and build new bone volume. A common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM) which resembles human bone and helps encourage new bone formation. On the contrary its structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate is another common bone substitute with easy handling properties and good structural stability during early healing. Its replacement by natural bone contributes to the augmentation process. Although DBBM efficacy in GBR process has been investigated, using DBBM in combination with bi-phasic calcium-sulphate as a binding material during GBR was not examined. This prospective study will examine augmented bone quality and quantity following a GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in a combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will precede dental implant placement as custom. The quality and quantity of the new formed bone will be assessed by a C.T (computerized tomography) which is done routinely before dental implant placement and by further analyses of bone residues which will follow drilling the dental implant placement site while preparing it (as common).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women over 18 years of age, eligible for signing
  • Edentulus Patients who require a GBR procedure previous to an insertion of a dental implant
  • Patients who understand the meaning of the treatment (routine Guided Bone Regeneration and dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

  • Pregnant or nursing women.
  • C567890-hildren or non judgemental patients
  • Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
  • Patients with a pathology present near the site of dental implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-Oss
In this arm,GBR will be performed with DBBM (Bio-Oss, Geistlich) in 25 patients.
Device: Bio-Oss (by Geistlich)
Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.
Other Names:
  • Deproteinized Bovine Bone Mineral
Experimental: Bio-Oss and BondBone
In this arm, GBR will be performed using a combination of DBBM (Bio-Oss, Geistlich) and bi-phasic calcium sulphate (BondBone, Augma) in 25 patients.
Device: Bio-Oss (by Geistlich)
Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.
Other Names:
  • Deproteinized Bovine Bone Mineral
Device: BondBone (by Augma)
Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.
Other Names:
  • bi-phasic Calcium-Sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 up to 7 months after the GBR procedure and before the insertion of dental implants.
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 up to 7 months after the GBR procedure and before the insertion of dental implants.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone quality
Time Frame: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion (up to 8 months following the GBR procedure).
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.
Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion (up to 8 months following the GBR procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

February 21, 2013

Study Completion (Actual)

February 21, 2013

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 20, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 26, 2017

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioOss-BondBone-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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