Treatment Trials

9 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Soft and Hard Tissue Changes Around Implants
Description

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.

ACTIVE_NOT_RECRUITING
Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts
Description

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.

COMPLETED
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation
Description

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.

TERMINATED
Safety Study of Gintuit™ in Subjects Requiring Socket Grafting
Description

This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).

COMPLETED
Efficacy of Socket Grafting for Alveolar Ridge Preservation
Description

The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.

UNKNOWN
Immediate Implant Placement in the Esthetic Zone
Description

This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate resorption and soft tissue recession following immediate implant placement in extraction sockets in the maxillary esthetic zone using different socket morphology-guided treatment modalities. Expected results of the study are: * To have found the optimal materials and GBR procedures modalities for buccal plate resorption degree reduction; * Soft tissue recession and best esthetic result achievement. There will be possibilities to study socket morphology influence on final esthetic result achievement.

COMPLETED
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Description

The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

COMPLETED
The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges
Description

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.

COMPLETED
Ridge Augmentation Comparing a Block Allograft to a Demineralized Bone Matrix Allograft.
Description

This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.