Treatment Trials

9 Clinical Trials for Various Conditions

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RECRUITING
Predict Tooth Wear
Description

Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. Prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. Recently, statistical shape analysis (SSA) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. However, assuring landmark consistency is challenging mostly due to biases of the operator. Recently, a robust method called MEG-IsoQuad offered automated, isotopological remeshing. Combining this with SSA holds promise for diagnostic and simulation purposes. This study aims to assess the reliability of a remeshing-SSA approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one. The clinical perspective of the current work offers possibilities to: * Prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth * Simulate the adapted reconstruction for the altered tooth by simulating the initially intact one

COMPLETED
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
Description

This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

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
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
COMPLETED
Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV
Description

Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials. Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction. Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.

NOT_YET_RECRUITING
3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children
Description

This study focuses on assessing dental caries, erosive tooth wear, and fluorosis in primary teeth using a 3D intraoral digital scanner. The investigator will validate findings using three key indices: ICDAS (for caries), BEWE (for erosive wear), and TF (for fluorosis). Teeth will be cleaned and examined visually using dental tools and light. After visual checks, teeth will be scanned with a 3D intraoral scanner. Children aged 3-12 years with fully erupted primary teeth, seeking dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry. The visual examination and digital scanning will be performed just once and during the dental appointment at the clinic of Pediatric Dentistry following the protocols used in the clinical routine. It is expected to complete the visual examination and the digital scanning in 30 minutes.

TERMINATED
Wear Characteristics of Denture Teeth
Description

The majority of teeth utilized in the fabrication of conventional complete dentures are made of acrylic resins. These acrylic teeth provide increased bond strength to the denture base and are much easier to adjust for correct denture occlusion compared to teeth made of harder materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain teeth, leading to alterations in how the teeth contact each other if the denture is not replaced periodically (typically every 5-8 years). With the increase in biting and chewing forces that can be achieved during function with dentures supported by dental implants, the rate of tooth wear may be increased, leading to more frequent need for replacement of the prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of fillers, including highly cross-linked organic macrofillers, high-density inorganic microfillers and silanized silica based nanofillers. The macrofillers are, to a large part, responsible for the adequate strength and color-stability of the teeth, whereas the microfillers improve the wear resistance. The nanofillers offer fundamentally different optical behaviour from those of larger fillers, improving light reflection without lowering the translucency. This offers additional opportunities in the development of composite teeth, which have to exhibit lifelike aesthetics and translucency. These teeth made of nano-particles and hybrid composites can be made with two different techniques, one where the materials are pressed together and another using an injection technique. The injection method has been found to have better aesthetic results, but resistance to wear in clinical use has not been established. The purpose of this study is to evaluate the wear characteristics of new resin denture teeth (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous subjects will be enrolled who have completed implant placement for mandibular implant overdentures opposing a maxillary complete denture or implant overdenture, or patients that have previously received these dentures and are interested in having new dentures. Both maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic recordings at baseline, 6, 12, 18 and 24 months after denture treatment.

Conditions
ACTIVE_NOT_RECRUITING
Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement
Description

The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system

COMPLETED
REFRAME RPD Post-Market Clinical Study
Description

To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM polymer Removable Partial Denture (RPD) for 8 weeks.