Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT01603693
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
Bone Quality and Quantity Following Guided Bone Regeneration With Bio-Oss Alone or Combined With BondBone, Prior to Dental Implant Placement
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: