Trial Summary
What is the purpose of this trial?The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material.
The study aims to examine the following main questions:
* Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing
* Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated.
The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:
* Demographic information
* Clinical information from intraoral photographs
* Radiographic information from cone beam computed tomography and periapical radiographs.
What safety data is available for bone grafts used in tooth extractions?The studies indicate that bone grafts such as demineralized freeze-dried bone allograft (DFDBA) and freeze-dried bone allograft (FDBA) are commonly used in dental procedures and have been associated with clinical success. Histologic evaluations show that DFDBA is well incorporated into new bone without significant inflammatory reactions or fibrous encapsulation, suggesting a good safety profile. Further research is recommended to explore the biological activity of these grafts in situ.13567
Do I have to stop taking my current medications for the trial?The trial requires that you stop taking certain medications. Specifically, you cannot participate if you are on immunosuppressants, steroids, bisphosphonates, or other medications related to Medication-Related Osteonecrosis of the Jaw (MRONJ).
Is the treatment CEBX, FDBA a promising treatment for tooth extractions?Yes, CEBX, FDBA is a promising treatment for tooth extractions. Studies show that it helps in bone healing and growth after tooth removal. It maintains the shape of the jawbone and supports new bone formation, making it a valuable option for dental procedures.14567
What data supports the idea that Bone Grafts for Tooth Extractions is an effective treatment?The available research shows that bone grafts like demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone are effective in promoting new bone growth after tooth extractions. One study found that DFDBA particles were well integrated into new bone up to 13 months after treatment, indicating successful bone formation. Another study compared different types of bone grafts and found that bovine-derived bone xenograft and mineralized cancellous bone allograft were effective in preserving the space where the tooth was removed. These findings suggest that bone grafts can help in the healing process by supporting new bone growth in the area where a tooth has been extracted.12456
Eligibility Criteria
This trial is for individuals needing a front tooth extracted and replaced with an implant. They should be suitable for bone grafting procedures using either human (FDBA) or cow-derived (CEBX) materials. Specific eligibility criteria are not provided, but typically participants must be in good general health and have adequate bone structure to support the dental work.Exclusion Criteria
I need a tooth pulled next to a gap in my front teeth.
I am taking medications that could increase my risk of jawbone problems.
I have untreated gum disease.
My front teeth have more than 5mm of bone loss on the cheek side.
I have had radiation therapy on my head or neck.
Treatment Details
The study compares two types of bone grafts: FDBA from humans and CEBX from cows, used after removing a front tooth. It aims to see which material better preserves jawbone shape over 16 weeks before placing an implant. Participants will randomly receive one type of graft during standard care visits.
2Treatment groups
Experimental Treatment
Active Control
Group I: FDBA armExperimental Treatment1 Intervention
Group II: CEBX armActive Control1 Intervention
CEBX is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Bio-Oss Collagen for:
- Dental implantology
- Bone augmentation
- Sinus floor elevation
- Ridge preservation
🇺🇸 Approved in United States as Bio-Oss Collagen for:
- Dental implantology
- Bone augmentation
- Sinus floor elevation
- Ridge preservation
🇨🇦 Approved in Canada as Bio-Oss Collagen for:
- Dental implantology
- Bone augmentation
- Sinus floor elevation
- Ridge preservation
🇦🇺 Approved in Australia as Bio-Oss Collagen for:
- Dental implantology
- Bone augmentation
- Sinus floor elevation
- Ridge preservation
Find a clinic near you
Research locations nearbySelect from list below to view details:
Eastman Institute for Oral HealthRochester, NY
Loading ...
Who is running the clinical trial?
University of RochesterLead Sponsor
Implant Dentistry Research & Education Foundation (IDREF)Collaborator
References
Histologic evaluation of human extraction sockets treated with demineralized freeze-dried bone allograft (DFDBA) and cell occlusive membrane. [2008]This study evaluated new bone formation in human extraction sockets treated with demineralized freeze-dried bone allografts (DFDBA) and celloc occlusive membranes. Hard tissue biopsies of 7 sites in 6 patients were obtained 14 weeks to 13 months following extraction and grafting. Histologic analysis revealed that individual particles of DFDBA were discernible up to 13 months in situ. In all samples, all particles of DFDBA were well incorporated within new bone, which exhibited osteocyte-containing lacunae. Distinct cement lines clearly demarcated the DFDBA particles from the surrounding, intimately-apposed woven and lamellar bone. The marrow demonstrated a mild degree of fibrosis without signs of inflammatory reaction. There was also a notable lack of fibrous encapsulation of the allograft, and little osteoclasis was observed. Our findings demonstrate that commercially available DFDBA has the potential to function physically as a nidus for appositional new bone growth in alveolar sockets following tooth extraction. Further investigations of the biological activity of DFDBA in situ are warranted.
Comparative histomorphometric analysis of extraction sockets healing implanted with bovine xenografts, irradiated cancellous allografts, and solvent-dehydrated allografts in humans. [2009]Bovine-derived bone xenograft and mineralized cancellous bone allograft have been successfully used as bone substitutes in dental surgery, but few clinical studies in humans have been reported. The objective of this study was to compare the osteoconductive effects of deproteinized bovine bone mineral (DBBM), irradiated cancellous allograft (ICA), and solvent-dehydrated allograft (SDA) when used to preserve extraction sockets.
Histologic comparison of healing after tooth extraction with ridge preservation using mineralized versus demineralized freeze-dried bone allograft. [2022]Allografts, such as demineralized freeze-dried bone allograft (DFDBA) and mineralized freeze-dried bone allograft (FDBA) are commonly used by clinicians for ridge preservation procedures. The primary objective of this study is to histologically evaluate and compare the healing of non-molar extraction sockets grafted with DFDBA versus FDBA for ridge preservation. The secondary aim of this study is to compare dimensional changes in ridge height and width after grafting with these two materials.
In vitro assay for osteoinductive activity of different demineralized freeze-dried bone allograft. [2022]Various bone graft materials have been used for periodontal tissue regeneration. Demineralized freeze-dried bone allograft (DFDBA) is a widely used bone substitute. The current widespread use of DFDBA is based on its potential osteoinductive ability. Due to the lack of verifiable data, the purpose of this study was to assess the osteoinductive activity of different DFDBAs in vitro.
Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. [2014]The objective of this study is to compare histologic and clinical healing following tooth extraction and ridge preservation with either cortical or cancellous freeze-dried bone allograft (FDBA) in non-molar extraction sockets.
Gene Expression and Microcomputed Tomography Analysis of Grafted Bone Using Deproteinized Bovine Bone and Freeze-Dried Human Bone. [2019]Bio-Oss and demineralized freeze-dried bone allograft (DFDBA) are two commercial bone grafts that have been associated with clinical success for many years. However, there are few in vivo studies regarding their healing mechanism. The purpose of this study was to investigate the level of bone formation using microcomputed tomography (micro-CT) and gene expression in mouse calvaria at 1 and 3 months after bone grafting with deproteinized bovine bone and freeze-dried human bone, and compare them to natural bone healing.
Protocol for Maintaining Alveolar Ridge Volume in Molar Immediate Implant Sites. [2020]Numerous biomaterials are available for augmenting bone around dental implants. In contained extraction sockets, a demineralized freeze-dried bone allograft (DFDBA) appears capable of maintaining dimensional stability of the alveolar ridge as well as mineralized alternatives but may yield a higher percentage of new vital bone. When DFDBA is used in large horizontal gap defects at molar immediate implant sites, graft containment and protection must occur through provisional restoration, an anatomic custom healing abutment, or by other means.