Treatment Trials

28 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Celtra Quatro Crown Study
Description

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

ACTIVE_NOT_RECRUITING
TetricCAD Crown Clinical Study
Description

This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

TERMINATED
Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns
Description

The purpose of this study is to investigate the use of an all-ceramic dental crown material to restore the abutment teeth of partially-edentulous patients who need removable partial dentures (RPD). The outcomes of the treatment group (all-ceramic crowns) will be compared to a similarly-treated control group whose RPD abutment teeth are restored using conventional metal and metal-ceramic crowns. Primary outcomes of interest include crown survival, abutment tooth survival and RPD survival.The null hypothesis is that at the conclusion of the study there will be no differences in outcomes between the two groups. All dental treatment, including dental hygiene and periodontal care, fillings, crowns and RPD fabrication will be provided by predoctoral dental students in the University of Kentucky College of Dentistry student clinics. Students treating the subjects will be supervised by licensed, technique-calibrated faculty specialists. Following the completion of dental treatment, enrolled subjects will be clinically re-evaluated by investigators at 6 months, and at annual intervals thereafter for 5 years following RPD delivery.

Conditions
TERMINATED
Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
Description

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

TERMINATED
Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Description

Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.

Conditions
RECRUITING
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
Description

The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.

Conditions
COMPLETED
Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves
Description

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.

COMPLETED
Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth
Description

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.

ENROLLING_BY_INVITATION
Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
Description

This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

Conditions
RECRUITING
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
Description

This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.

ACTIVE_NOT_RECRUITING
Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
Description

This is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. This investigation is intended as a Post Market Clinical Follow-up study for the product Cerec Tessera and its prosthetic assembly for implants, which will serve as a life-cycle approach to safety, backed up by clinical data and post-market monitoring.

RECRUITING
Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach
Description

In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).

NOT_YET_RECRUITING
Lithium Disilicate Crowns Study
Description

CAD-CAM crowns made of lithium disilicate are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.

COMPLETED
Clinical Trial NuSmile Crowns
Description

A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.

RECRUITING
A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.
Description

The purpose of this study is to compare the effectiveness of the Hall technique and modified Hall technique to the conventional Stainless-Steel Crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

Conditions
COMPLETED
Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol
Description

Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

COMPLETED
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Description

The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe repurposed interventions, with complementary mechanisms of action.

Conditions
UNKNOWN
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
Description

Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 . Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.

COMPLETED
Intraoral Imaging At Clinical Crown Lengthening
Description

Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone. After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.

TERMINATED
Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy
Description

The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab, certolizumab)

Conditions
COMPLETED
Bilateral; Flank Study With Crown Cooling Insert
Description

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

COMPLETED
Wear of Enamel Against Polished Zirconia Crowns
Description

A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic crowns. This single-blind pilot study will involve a total of 30 teeth that require full coverage crowns that oppose natural antagonist teeth. The objectives of this research are to test the following hypotheses: (1) differences between mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished veneer surface of metal-ceramic crowns are statistically significant; (2) differences between mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by opposing enamel are statistically significant; and (3) differences between mean antagonist wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by opposing enamel are statistically significant.

Conditions
UNKNOWN
Trial of a New NuSmile ZR Esthetic Primary Molar Crown
Description

The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.

Conditions
COMPLETED
Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements
Description

The restoration of indirect partial and full coverage restorations in dentistry necessitates the use of a luting agent to act as a means of mechanical and potentially, chemical retention of the restoration. Upon the introduction of the first generation of glass Ionomer cements for use as a luting agent, an elevated short-term post operative hypersentivity was reported. In part, this adverse event was considered to be due to a desiccating effect of the cement as water is utilized in the setting reaction and thus a desiccation of the dentinal tubules was proposed as a potential mechanism leading to disruption of the neurosensory odontoblasts. Further materials development in the field of dental cement luting agents has lead to the introduction to the current market of resin formulations that have an alternative mechanism of setting. Consequently, there are anecdotal reports of a decrease in the incidence of post-operative sensitivity but no comparison with the effect of conventionally used dentin desensitizing agents as a part of the bonding process of the restoration. The purpose of this trial is a single blinded parallel design randomized clinical trial to evaluate the perceived incidence of post-operative sensitivity when full coverage all ceramic crowns or short-span three unit fixed partial dentures (dental bridge) is fabricated in the posterior part of the mouth. The dental crowns or bridges will be bonded with conventional glass ionomer cement or a Urethane dimethacrylate / Bis-GMA composite resin dental cement. Outcome measures will be both objective clinical criteria and the use of a calibrated pain survey instrument.

ACTIVE_NOT_RECRUITING
Alternative EndoCrowns Designs for Chairside CAD/CAM
Description

This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

TERMINATED
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
Description

Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.

COMPLETED
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Description

The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.

Conditions
COMPLETED
Analysis of Enamel Wear Against Ceramic Restorations
Description

1. To characterize the microstructure (fracture toughness, particle size of ceramic, and inter-particle spacing) of three ceramic materials 2. To test the hypothesis that lower fracture toughness of glass and/or crystal phase in ceramics reduce wear damage of enamel. 3. To test the hypothesis that smaller sized crystals reduce wear damage of enamel. 4. To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel. 5. To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel. 6. To test the hypothesis that bite force does not correlate with wear rates. 7. To test the hypothesis that salivary flow does not correlate with wear rates. 8. To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion. 9. To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process. 10. To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years. 11. To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements

Conditions