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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01603693
First received: May 7, 2012
Last updated: September 8, 2013
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Resorbed Alveolar Ridge Prior to Dental Implant Insertion
Device: Bio-Oss (by Geistlich)
Device: BondBone (by Augma)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Quality and Quantity Following Guided Bone Regeneration With Bio-Oss Alone or Combined With BondBone, Prior to Dental Implant Placement

Resource links provided by NLM:


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 up to 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 (up to 8 months following 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.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: bi-phasic Calcium-Sulphate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01603693

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

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01603693     History of Changes
Other Study ID Numbers: BioOss-BondBone-HMO-CTIL
Study First Received: May 7, 2012
Last Updated: September 8, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Guided bone regeneration
Bio Oss
BondBone
computerized tomography
histological examination

ClinicalTrials.gov processed this record on November 27, 2014