45 Clinical Trials for Various Conditions
The main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation, including bone allografts (bone grafts derived from a human tissue donor). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.
The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared.
This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.
Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method. In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge? The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.
The primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap.
Tooth loss is accompanied by different patterns of bone loss. Up to 50% loss of alveolar crestal bone width will likely occur 1 year after tooth loss, especially in the anterior maxilla. A great percentage of the process of alveolar bone resorption occurs within the first 3 to 6 months post-extraction. If ridge preservation is not conducted, 40%-60% of the total alveolar bone volume is lost during the first 2-3 years post-extraction, and this phenomenon has shown to continue to occur at a rate of 0.25%-0.5% loss per year. It has been proposed that ridge augmentation procedures may reduce the expected ridge reduction after tooth loss. Ridge augmentation procedures may require the use of bone grafts and non-resorbable or non-resorbable barrier membranes. The use of non-resorbable barrier membranes for ridge augmentation has the clinical disadvantage of needing a second procedure for its removal during the healing phase. Osteogen® plug (OPP) consists of a non-ceramic bone graft incorporated in type I bovine Achilles tendon collagen. OPP was first developed to serve as a one-step grafting solution for ridge preservation without the need for a barrier membrane
The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched. Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement. The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement. Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone. Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.
The study will consist of randomized controlled clinical study trial comparing the results of a demineralized putty allorgraft versus a combined mineralized/demineralized putty allograft in approximately 30 patients, 15 per group. All materials used in the study are FDA approved.
The purpose of this study is to compare the speed of bone healing of the two most commonly used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge preservation model in participants scheduled for tooth extraction and subsequent receipt of a dental implant. Researchers hypothesize that there will be additional vital bone at 16-20 weeks with Salvin-Oss®.
Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures. Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a tooth). Therefore, we would like to place small screws at the extraction sites to preserve the alveolar bone when the teeth need to be extracted and a patient cannot start treatments some time. Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We will recruit patients who require extractions of two upper small molars (maxillary premolars) on both right and left sides. We will place one mini-screw on one side while the other side will be untouched after teeth extractions. Both sides will be followed at 8 months for examinations.
This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.
This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All subjects recruited will have already been approved and treatment planned for extraction + implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have radiographs that show the tooth planned for extraction. Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth extraction, subjects will receive a standard site preservation therapy consisted with xenograft bone substitute + collagen dressing or the alternative site preservation therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month healing period, subjects will receive a dental implant in the previous extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for future histological and histochemical analysis. After dental implant placement, all subjects will receive a healing abutment for soft tissue healing prior to implant restoration. During the 6-month healing time after tooth extraction and site preservation therapy, subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate extraction planning and at 6-month post-extraction for volumetric measurement and appropriate implant treatment planning. Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs. 6-month healing). CBCT images will be analyzed by non-contact reverse engineering system. Soft tissue volumetric analysis will be performed to compare the soft tissue healing between BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.
The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.
This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket preservation procedures, both when the socket is filled and overfilled with freeze dried bone allograft (FDBA).
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel Biocare,), a low-cost allograft material, 90 days following exodontia.
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Bone grafting following tooth extraction is commonly performed to preserve bony ridge dimensions adequate to support subsequent implant placement. Alveolar ridge resorption commonly occurs following tooth extraction, and the decrease in bone volume has the potential to make dental implant therapy impossible without surgery to reconstruct the ridge. The aim of ridge preservation grafting is to prevent or minimize this resorptive process, thereby preserving an adequate volume of bone for implant placement. Ridge preservation generally involves placement of a particulate bone graft material in the tooth socket, followed by use of a membrane or similar substance over the socket entrance to contain the bone graft. Various grafting materials have been recommended for these ridge preservation procedures, including demineralized freeze-dried bone allograft (DFDBA). The timing of dental implant placement following ridge preservation procedures is controversial, and few studies have examined the effects of different healing time intervals between ridge preservation and implant placement. The purpose of this project is to evaluate the formation of new bone at a site where tooth extraction has been performed followed by grafting using DFDBA. Two different study groups are included, one having the dental implant placed 8-10 weeks after tooth extraction and ridge grafting, the other having the dental implant placed 18-20 weeks after extraction and grafting.
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.
This entire protocol involves procedures that are standard care. The purpose of the research is to evaluate whether there are any differences in new bone formation following tooth extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or a combination of 70% mineralized \& 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are commonly used in dentistry for this purpose. Until recently, there has been no human evidence of differences in new bone formation with one material versus another. Recently, DFDBA has been shown to provide a greater percentage of vital bone formation than FDBA. No studies have been done on materials that provide a combination of demineralized and mineralized FDBA for ridge preservation. That is the purpose of this study. There will be two subject groups in this study. All subjects will require extraction of at least one non-molar tooth, followed by replacement of the missing teeth with dental implants. Each group will have 22 subjects. The primary distinction between groups will be the use of either a combination of 70% mineralized \& 30% demineralized FDBA or 100% mineralized FDBA: Group 1 will have 70% mineralized \& 30% demineralized FDBA grafted into the extraction socket for ridge preservation. Group 2 will have 100% mineralized FDBA grafted into the extraction socket for ridge preservation. The allocation of subjects into group 1 or 2 will based on numbers drawn from a stack of sealed envelopes. A small flap will be reflected to an extent about 3-4mm beyond the bony walls of the socket. A measuring stent will be placed and measurements of ridge width and ridge height will be taken and recorded to the nearest 0.5mm. Ridge width will be measured using a ridge caliper at a point approximately 4mm apical to the facial and lingual bony crest. Ridge height will also be measured. The tooth will be extracted and the subject will then be randomized by drawing a sealed envelope from the stack. Either 100% mineralized FDBA or a combination of 70% mineralized \& 30% demineralized FDBA will be placed in the socket to restore the ridge to appropriate contour. A dense polytetrafluoroethylene (PTFE) membrane will then be placed over the socket orifice extending about 3mm beyond the bony socket walls. A PTFE suture will be placed over the membrane to secure it in place. Primary closure will not be attempted. The patient will be seen 7-10 days after extraction/ridge preservation to assess healing. The subject will be seen again 21-28 days to remove the PTFE membrane and to assess clinical healing. At the time of implant placement, the measuring stent and caliper will be used to determine the ridge width and ridge height again. The implant site will be prepared using a hollow trephine which allows retention of the bony core. The bone removed from the osteotomy site remaining in the trephine will be prepared for histologic examination and analyzed for new bone growth. The following histologic parameters will be measured: percent vital bone formation; percent residual graft material; and, percent nonmineralized connective tissue/bone marrow. Following initial preparation of the implant site with the trephine, an implant of the appropriate length and diameter will be placed. A healing abutment will then be placed. All subjects will be examined at 7-10 days following implant placement. The study will end at the time of this follow up visit. The patient will then be referred to his/her restorative dentist for final restoration.