Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement
| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2012 | ||||
| Last Updated Date | May 20, 2012 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01603693 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement | ||||
| Official Title ICMJE | Bone Quality and Quantity Following Guided Bone Regeneration With Bio-Oss Alone or Combined With BondBone, Prior to Dental Implant Placement | ||||
| Brief Summary | 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Resorbed Alveolar Ridge Prior to Dental Implant Insertion | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Lang NP, Hämmerle CH, Brägger U, Lehmann B, Nyman SR. Guided tissue regeneration in jawbone defects prior to implant placement. Clin Oral Implants Res. 1994 Jun;5(2):92-7. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | June 2016 | ||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01603693 | ||||
| Other Study ID Numbers ICMJE | BioOss-BondBone-HMO-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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