57 Clinical Trials for Various Conditions
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.
The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the Investigators to determine: (1) If placement of Endosseous Titanium Implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) The final position of the implant, the ability to fabricate prosthesis. (3) Body image, diet and perceived ease of chewing selected foods. Selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth must be congenitally missing. A total of 30 patients will be included. A consent to participate in this study will be obtained from each patient: 18 \& older - consent signed by patient 13-17 years - consent signed by parent, assent signed by patient 7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study
The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.
A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.
A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning. Additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field. The ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed to compare bone width measurements between US and CBCT. This study also investigated the possible correlation between the crestal bone surface quality imaged by US and CBCT.
This study will evaluate the effect of allograft bone particle size on the bone quantity and quality following socket grafting and lateral ridge augmentation in preparation for endosseous implant placement. Pre (baseline)- and post-grafting (3 months for sockets and 6 months for edentulous ridges) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the differences between sites grafted with small vs. large particle sized bone allografts. Histological analysis will be performed at time of surgical re-entry of grafted sites to place the dental implants, and assessed for differences in new bone formation between the 2 types of grafts.
Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient dimension to permit dental implant placement. While a wide variety of bone graft and barrier membrane products are commercially available, limited evidence exists supporting the use of one technique over another. The purpose of this study is to radiographically define the dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR® (Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of inflammation, infection, or other wound healing complications. Participants: A total of 60 patients requiring bone augmentation of a single bound edentulous site prior to dental implant placement will be selected for this study. This is a multicenter study with 30 patients receiving treatment at each study site. Procedures (methods): Patients will be randomly allocated to receive horizontal bone augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA), synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. Cone beam computed tomography (CBCT) imaging will be obtained at baseline and 6 months post-operatively to assess dimensional alveolar ridge changes. Additionally, post-operative appointments at 1, 2, and 4 weeks post-grafting will be completed to assess the presence of inflammation, infection, wound dehiscence, or membrane exposure.
This study is designed to recall all patients who have received a full-arch monolithic zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC) School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and technical complications associated with this form of prosthetic treatment. Additionally patient centered outcomes will be evaluated.
The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.
This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.
Dental implants are used in dentistry to reestablish function and appearance to areas of the mouth where natural teeth are missing. Implants can be a good choice for almost all areas of the mouth except where the space left by missing teeth is too narrow. This is usually the case when front teeth are lost of have been missing since birth. The Maximus dental implant is the smallest implant made, just 3mm in diameter, and is especially designed to replace missing front teeth and yet be strong enough to function as a natural tooth. This study will assess the functional success of BioHorizons Maximus one-piece endosseous dental implant. We hypothesize that placement of the 3mm dental implant in areas of limited tooth-to-tooth spacing will be an efficacious tooth root replacement.
The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans. The main question\[s\] it aims to answer are: * Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans? * Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results? Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment. Scanbodies were screwed into their implants for the duration of the appointment. They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry. Intraoral and extraoral photography were taken. At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted. The procedures were not painful or required any form of local anesthetic Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.
Our long-term goal is to generate evidence for the creation of successful implant restorations and ideal supporting tissues in adequate health by utilizing patient-tailored implant protocols such as the use of customized computer-aided design and computer-aided manufacturing (CAD/CAM) healing abutments. With this study, the investigators intend to recruit patients requiring a single implant placement and implant crown in molar areas. Patients will be randomly assigned to either the control group that will receive standard healing abutments or the test control group that will receive customized CAD/CAM healing abutments. Patients will be followed for six months after the delivery of the implant crowns. The central hypothesis is that the use of customized CAD/CAM healing abutments will demonstrate improved outcomes in terms of hard and soft tissue volume stability and clinical parameters as compared to the use of standard healing abutments. Aim 1 will measure soft and hard tissue changes around dental implants when customized CAD/CAM healing abutments are utilized as compared to standard healing abutments. Soft tissue stability will be measured utilizing intraoral digital scans, while osseous levels will be measured utilizing CBCT scans. Soft and hard tissue volumetric and linear changes will be measured by digital scan superimposition at the time of crown delivery and 6 months thereafter. Volumetric and linear changes will be compared within each group at different time points and between the test and control group to determine if the use of customized CAD/CAM healing abutments is advantageous in terms of maintaining peri-implant soft and hard tissue stability. Aim 2 will assess different clinical measurements around dental implants to analyze if the use of customized CAD/CAM healing abutments will demonstrate improved plaque control and peri-implant health as compared to standard healing abutments. Plaque index (PI), gingival index (GI), probing depths (PD), and bleeding on probing (BOP) will be obtained at the time of crown delivery and at 3 and 6 months. Clinical measurements will be compared between the test and control group to determine if the use of customized CAD/CAM healing abutments will aid in obtaining a natural looking restoration that would result in improved clinical parameters that measure peri-implant health. Aim 3 will compare the degree of patient satisfaction using a visual analogue scale (VAS) in patients that received an implant restoration following the use of a customized CAD/CAM healing abutment as compared to standard healing abutments. Patients will complete a VAS questionnaire that will evaluate patient perception of pain, esthetics, ability to chew, and ability to clean. Scores will be compared among groups to evaluate if there is a difference in patient-centered outcomes when customized healing abutments are used as compared to standard healing abutments.
Older removable denture wearing adults suffer from a complex set of oral health challenges, with relatively few solutions identified at this time. This is substantiated by statistics concerning the geriatric population on the correlation of poor oral health and the degradation of an individual's overall quality of life. The most recent National Health and Nutrition Examination Survey data found that 1 in 8 U.S. adults over the age of 65 are completely edentulous. A shift from complete edentulism to partial edentulism was also seen in this survey data, as the average individual over 65 had only 21 teeth remaining. Thus, partial edentulism remains a significant burden on seniors as well. Clearly, there exists both a great need and desire for improved implementation of proven oral-health strategies among this population, as well as the development of new preventive interventions and minimally invasive treatment strategies beyond traditional denture adhesive products. This proposed clinical trial intends to investigate two such potential treatment aids. In follow-up from our recent pilot study investigating MI Paste's application on the intaglio of complete dentures, in which our current findings have shown that the use of MI Paste can predictably increase the buffering capacity of a patient's saliva, our current proposal targets to further increase the study's sample size to improve the statistical power regarding subjective patient reports. The primary aims of this proposed study are to collect further data on how MI Paste affects patients' subjective evaluations of the comfort and retention of their denture, as well as dry mouth symptoms in patients reporting xerostomia. Furthermore, this study will include a second therapeutic intervention, Biotene Dry Mouth Gel (OTC), which will provide an additional contrast variable involving patient preferences regarding therapeutics under their removable prostheses. We hypothesize that the use of both therapeutics underneath removable dentures will provide added retention and stability to the prosthesis on patient reports, further coinciding with improved evaluations of comfort and function. Additionally, we hypothesize that the subjective improvements in patients self-reporting xerostomia will be of a statistically greater magnitude than those noticed by patients with normal salivary function, as xerostomia has been associated with increased denture discomfort in past literature.
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site. Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (\> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.
This will be a prospective, randomized, observational study. All implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture
This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using Additive Manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for Additive Manufacturing (M2 series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the trial includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.
This will be a prospective, observational multicenter study. All implants will be placed in the anterior maxilla or mandible and immediately loaded with a provisional prosthesis out of occlusion. Final restorations insertion will take place no later than 6 months following implant placement surgery. All implants will be restored with a single crown or splinted to a pre-existing implant if in the pre-molar region (no 2 adjacent edentulous sites).
Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
This study will identify and enroll patients already scheduled to receive guided maxillary implant placement with palateless overdenture. Standard clinical practice will be followed for this multi-stage process. The study purpose is to evaluate the degree of satisfaction during the standard progression in order to determine at which post edentulous stage patients achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).
Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes. Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures. Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.
This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. This 24-month research study will examine the clinical stability of TMDI in both sinus elevation and sinus augmentation environments. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the effects TMDI have on clinical success in less than optimal osseous environments. The rationale that underlies the investigation is that identification of the influences of trabecular surface design on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid, economical health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, the results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density with or without the use of graft materials in sinus lift procedures. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios: 1. If the soft tissue around your tooth is thin, following extraction and implant placement an extra soft tissue graft (taken from your palate) in the area in order to increase the thickness of your gums after healing. 2. If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft. Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study. The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.