Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342973
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-27
Brief Title:
Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Louisiana State University Health Sciences Center in New Orleans
Study Overview
Official Title:
Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane
Detailed Description:
The aim of the study is to evaluate the outcomes of horizontal gone gain when demineralized freeze dried bone allograft DFDBA and xenograft are used in a layering technique
Primary objectives are to compare the bone gain after the bone augmentation procedure Secondary outcomes are to study the vital bone percentage formation after the bone augmentation procedure and to study the amount of shrinkage of the graft material observed after the procedure
Test group will consist of patients receiving horizontal ridge augmentation using a combination of DFDBA layered with xenograft particulate bone using a resorbable collagen membrane Surgical procedure is describe under assigned interventions
Follow up and implant placement
The patients will be followed up at 1-2 3-5 and 6-8 weeks to assess the surgical site for healing Following this the patient will be allowed to heal for a period of 6-9 months at which point a cone beam computed tomography CBCT will be taken to evaluate the bone gain after horizontal ridge augmentation
CBCT Measurements
The images obtained from the CBCT scan will be transferred to a digital CBCT viewing software in which measurements will be carried out The anatomical landmarks and adjacent teeth will be identified and used to orient the scan to get an image representing the buccal-palatal plane of the area of interest The horizontal bone gain will be measured at 357 mm from the crest Additionally the amount of graft shrinkage will be measured between immediate post-operative CBCT and follow up CBCT
Bone core biopsies
Following at least 6 months of healing and follow up patients will be appointed for implant placement At this visit a full thickness flap will be raised If anatomical considerations and space permits a bone core biopsy will be obtained using a trephine and stored in formalin for histologic and histo-morphometric analysis The harvesting of a bone core is considered additional for the study It will only be performed if it is safe to do so and the harvesting of the core will not jeopardize the long-term longevity of the implant placement not all patients that are part of the study will undergo the harvesting of a bone core This bone core will be saved for histologic analysis
Histologic preparation and evaluation
Following the bone core removal the biopsied specimens will be stored until further evaluation The bone core biopsies will be prepared and evaluated at a lab De-identified samples will be shipped to the lab for further analysis Briefly the biopsy will be dehydrated in a series of ethanol baths Following this it will be infiltrated in xylene and methyl metha-acrylate Following embedding the bone samples will be sectioned using a hard tissue microtome and stained with hematoxylin-eosin The quantitative assessment of percentage vital bone graft particles and connective tissue will be measured using a grid under magnification
Primary objectives are to compare the bone gain after the bone augmentation procedure Secondary outcomes are to study the vital bone percentage formation after the bone augmentation procedure and to study the amount of shrinkage of the graft material observed after the procedure
Test group will consist of patients receiving horizontal ridge augmentation using a combination of DFDBA layered with xenograft particulate bone using a resorbable collagen membrane Surgical procedure is describe under assigned interventions
Follow up and implant placement
The patients will be followed up at 1-2 3-5 and 6-8 weeks to assess the surgical site for healing Following this the patient will be allowed to heal for a period of 6-9 months at which point a cone beam computed tomography CBCT will be taken to evaluate the bone gain after horizontal ridge augmentation
CBCT Measurements
The images obtained from the CBCT scan will be transferred to a digital CBCT viewing software in which measurements will be carried out The anatomical landmarks and adjacent teeth will be identified and used to orient the scan to get an image representing the buccal-palatal plane of the area of interest The horizontal bone gain will be measured at 357 mm from the crest Additionally the amount of graft shrinkage will be measured between immediate post-operative CBCT and follow up CBCT
Bone core biopsies
Following at least 6 months of healing and follow up patients will be appointed for implant placement At this visit a full thickness flap will be raised If anatomical considerations and space permits a bone core biopsy will be obtained using a trephine and stored in formalin for histologic and histo-morphometric analysis The harvesting of a bone core is considered additional for the study It will only be performed if it is safe to do so and the harvesting of the core will not jeopardize the long-term longevity of the implant placement not all patients that are part of the study will undergo the harvesting of a bone core This bone core will be saved for histologic analysis
Histologic preparation and evaluation
Following the bone core removal the biopsied specimens will be stored until further evaluation The bone core biopsies will be prepared and evaluated at a lab De-identified samples will be shipped to the lab for further analysis Briefly the biopsy will be dehydrated in a series of ethanol baths Following this it will be infiltrated in xylene and methyl metha-acrylate Following embedding the bone samples will be sectioned using a hard tissue microtome and stained with hematoxylin-eosin The quantitative assessment of percentage vital bone graft particles and connective tissue will be measured using a grid under magnification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None