Treatment Trials

29 Clinical Trials for Various Conditions

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TERMINATED
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
Description

The objective of this study is to evaluate the clinical safety and performance of Optibond Universal (OBU), a single component universal dental adhesive intended for indirect dental restorations according to manufacturer's Instruction For Use.

COMPLETED
Cold Plasma for Dental Restoration and Caries Prevention
Description

The main objective of this entire research project is to develop a miniature atmospheric cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial portion of the study is to compare the longevity and durability of dental composite restorations created using the plasma brush, to that of the standard care in dentistry for treating dental cavities, and effects on caries prevention.

COMPLETED
High-strength Glass-ionomer Dental Restorations
Description

The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials. The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.

Conditions
COMPLETED
DPBRN Reasons for Replacement or Repair of Dental Restorations
Description

The purpose of this study was to document the reasons for replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth.

Conditions
COMPLETED
DPBRN Patient Satisfaction With Dental Restorations
Description

The purpose of this study was to administer two questionnaires. The first, a Dental Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using patients recruited from practices participating in the Dental PBRN "Reasons for replacement or repair of dental restorations" study. The second questionnaire (completed by the practitioner) was a brief single page questionnaire to evaluate the patient visit.

COMPLETED
DPBRN Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces
Description

The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study, and the factors affecting how long the fillings last.

Conditions
COMPLETED
DPBRN Longitudinal Study of Repaired or Replaced Dental Restorations
Description

The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for replacement and repair of dental restorations" study, and the factors affecting how long the fillings last.

Conditions
TERMINATED
Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Description

Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

COMPLETED
Levels of Bisphenol A in Urine and Saliva Following Placement of Composite Restorations
Description

This study will determine whether placement of composite (white) dental restorations (fillings) increases concentrations of bisphenol A (BPA) and its metabolites in saliva and urine. These compounds have estrogenic-like properties that have raised concerns about their safety. Small amounts of the chemicals can leach out of dental sealants and be detected in saliva soon after the sealants are applied. Dental composites also contain some of these compounds. U.S. Commissioned Corps officers who need fillings as part of their regular dental treatment and who select composite (white) restorations instead of amalgam (metal) may be included in this protocol. Participants are recruited from among officers receiving dental care at the commissioned officers dental clinic in Rockville, Md. Participants complete a 15-minute interview to gather information about their recent diet and eating patterns. They also provide 3 to 4 urine and saliva samples, some collected before their dental restoration and some after treatment.

COMPLETED
Clinical Performance of Posterior Composite Tooth Fillings in Adults
Description

The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

ACTIVE_NOT_RECRUITING
Early Caries Lesion Management Observational Study
Description

The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion. The study will also evaluate the effectiveness of CRFP in comparison to no tooth-specific treatment control groups, including whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste; and no treatment, on caries arrest and in preventing progression to cavitation in patients with at least one early non-cavitated dental lesion.

COMPLETED
Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
Description

The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.

Conditions
RECRUITING
Efficacy of a Dental Implant System for Immediate Restoration
Description

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays.

Conditions
COMPLETED
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Description

The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

Conditions
ENROLLING_BY_INVITATION
Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
Description

This investigation will be a prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, 3D shaded zirconia material for computer assisted design and computer assisted machining for chairside restorations. The restorations will be evaluated for a period of up to five years. The study is called Clinical Study of a 3D Shaded Zirconia for chairside computer assisted design and computer assisted machining (CAD/CAM) chairside restorations intended to be part of the validation plan and post market follow-up of the following products: CEREC Cercon 4D, Calibra Universal +, and Prime and Bond Active.

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.

ACTIVE_NOT_RECRUITING
Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal
Description

This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This study will evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.

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
Clinical Performance of Chairside CAD/CAM Restorations
Description

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive. Full contour zirconia crowns will be cemented using a self-adhesive resin cement.

COMPLETED
Comparative Effectiveness of Treatments to Prevent Dental Caries
Description

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New Hampshire.

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.

COMPLETED
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Description

This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

Conditions
COMPLETED
Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
Description

The purpose of this study is to compare two different timings of restoring dental implants that are placed right after tooth extraction: The test group will have the provisional crown placed at the time of implant placement. The control group will have the tooth removed and the implant placed at the same appointment but restorations placed after 4 months. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best timing for restoring implants for their patients. The hypothesis is that immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.

COMPLETED
DPBRN Reasons for Placing the First Restoration on Permanent Tooth Surfaces
Description

The purpose of this study was to document the reasons for placing the first restoration ("filling") on a previously un-restored surface in a permanent ("adult") tooth.

Conditions
COMPLETED
Clinical Trial NuSmile Crowns
Description

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

COMPLETED
Clinical Evaluation of a Bulk Fill Resin Composite
Description

The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.

COMPLETED
Comparative Effectiveness of School-based Caries Prevention
Description

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.

COMPLETED
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Description

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities. In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.

Conditions
COMPLETED
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Description

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth. Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

Conditions