NCT06342973

Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 3,5,7 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.

Conditions

• Alveolar Ridge Deficiency

Interventions

Type	Name	Description
DEVICE	Xenograft and allograft	For the guided bone augmentation procedure, a crestal incision with one or two vertical incision will be made and a full thickness mucoperiosteal flap will be elevated. Decortication will be performed and the patient will receive grafting with DFDBA with a buccal overlay of xenograft. A bi-layered native collagen membrane will be used and fixed with tacks or sutures. Periosteal incisions will be made to get tension free primary closure. The flap will be closed with sutures. Patients will be prescribed antibiotics, analgesics and mouth rinses as appropriate.

Timeline

• Start date: 2024-03-27
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2024-04-02
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study