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Clinical Trials: Dental, Including Mouth
IRB No. 02-288-2 (Dr. Anna Dongari-Bagtzoglou, PI): Oral Epithelial Cell Cytokines Candida and PMN Activation
This is a research study that examines the ways by which human blood cells fight yeast infections of the mouth. More specifically, we are interested in the activation of human cells in response to mucosal cell products called cytokines.
IRB No. 14-056-6 (Dr. Pamela Taxel, PI): Investigation of the Ability of the UCONNS (University of Connecticut OsteoNecrosis Numerical Scale) to Predict the Risk for the Developing Osteonecrosis of the Jaw in Women Receiving Bone-Modifying Therapies for Cancer
The purpose of this proposal is to investigate the risk factors for osteonecrosis of the jaw (ONJ), a known complication of several bone-modifying therapies used in the treatment of advanced cancers. When this complication occurs, it can lead to the discontinuation of important therapy that often impacts the quality of life in skeletal-related events in this population. With the use of a weighted scale that we have devised, the University of Connecticut OsteoNecrosis Numerical Scale (UCONNS), based on known risk factors for ONJ, we aim to validate this scale as a potential predictor of patients at risk, so they may be appropriately monitored and preventative treatment can be initiated. As the medical community has limited guidelines regarding ONJ, we anticipate that this scale, if validated, will foster better communication among providers, as well as improve patient outcomes. This proposal represents a unique collaboration between two investigators in the dental and medical schools at the University of Connecticut Health Center. We hypothesize that the UCONNS can aid in the identification of cancer patients who may be at increased risk for the development of ONJ associated with the use of bisphosphonates and the newer bone modifying therapy, denosumab.
IRB No. 14-057-6 (Dr. Pamela Taxel, PI): Investigation of the Ability of the UCONNS (University of Connecticut OsteoNecrosis Numerical Scale) to Predict the Risk for the Developing Osteonecrosis of the Jaw in Women Receiving Bone-Modifying Therapies for Breast Cancer
The aim of this proprosal is to investigate the risk factors for Osteonecrosis of the Jaws (ONJ), a known complication of several bone-modifying therapies including bisphosphonates and denosumab, a human monoclonal antibody. ONJ is most commonly seen with the use of these medications in the treatment of skeletal related events in cancer patients with metastatic bone disease, and less frequently seen in the treatment of osteoporosis. This complication often causes significant effects on quality of life that may lead to the discontinuation of important disease-modifying therapy. We have recently developed the UCONNS (University of Connecticut OsteoNecrosis Scale) a weighted scale based on known medical and dental risk factors for ONJ that we are currently validating both retrospectively and prospectively for use as a potential predictor of patients at risk, so they may be appropriately monitored and preventative treatment can be initiated. The current proposal aims to add to the UCONNS by prospectively measuring serum bone markers that may prove valuable in predicting patients that are at increased risk for developing ONJ. We will follow patients who are being treated with bone modifying agents in order to prospectively measure and evaluate a panel of unique parameters of bone metabolism to identify potentially predictive serum biomarkers for the development of ONJ. We hypothesize that the UCONNS can aid in the identification of breast cancer patients who may be at increased risk for the development of ONJ associated with the use of bisphosphonates and the newer bone modifying therapy, denosumab.
IRB No. 14-179-1 (Dr. Rajesh Lalla, PI): Oral Microbiome in Head and Neck Cancer Patients
This research study is about the community of germs that live in the mouth (the oral microbiome) and its relationship to oral complications of radiation therapy such as dryness, mouth sores, tooth loss, cavities, gum disease or poor healing of bone. The purpose of this study is to look at changes in the oral microbiome from before radiation therapy until 18 months after radiation therapy to see if certain characteristics of the oral microbiome relate to mouth problems that may occur after radiation therapy. An optional sub-study is about future genetic testing of saliva samples to look for genes that may affect the risk of oral complications of radiation therapy..
IRB No. 14-221-3 (Dr. Martin Freilich, PI): Two-implant supported maxillary overdentures: Clinical and patient reported outcomes.
PROJECT SUMMARY Maxillary overdentures supported by four implants have clearly shown to be effective and provide improved function as compared to conventional dentures, particularly when alveolar ridges are resorbed and when palate form is shallow. This preliminary, descriptive study aims to prospectively study the efficacy of only 2 implants to support maxillary complete dentures. The specific aims of this study are: 1) To generate an estimate of three-year implant and prosthesis success for two implant-retained maxillary complete denture prostheses; and 2) To better understand patient reported outcomes across time. Upon IRB approval and patient recruitment into the trial using pre-determined inclusion and exclusion criteria, 20 maxillary edentulous patients will be provided with two implants to support their existing denture. Each patient will receive two dental implants bilaterallly in the maxillary anterior region at the lateral incisor/canine regions. After successful osseointegration, two “Locator” abutments will be inserted over the implants and the patient’s existing denture will be attached to the abutments through a laboratory reline of the denture and thus converted to a two-implant retained maxillary overdenture. Thereafter follow-up exams will be performed and clinical outcomes and patient-reported outcomes will be studied at baseline (conventional complete dentures); 1 week post-insertion of relined maxillary overdenture; 6-months; 1 year post-insertion; 2 years post-insertion; and 3 years post-insertion (all two-implant supported maxillary overdenture). The clinical outcomes will be recorded in a descriptive manner for variables including implant survival, surgical complications, radiographic bone levels, plaque index/bleeding index around the implants, prosthetic complication, wear or loosening of the abutments, replacement of the nylon inserts and other descriptive variables. The patient-reported outcomes will be recorded at follow-up appointments using a visual analog scale (VAS) and a modified oral health impact profile (OHIP-14). Additional follow-ups as required by each patient for any adverse outcomes related to treatment will also be documented. Those variables that allow comparison to conventional denture will be compared using statistical measures. SPECIFIC AIMS This descriptive, patient based study is designed to determine implant survival for dental implants and the success of implant retained complete removable prostheses when only two implants are utilized. It is well known that there is a projected increase in the number of edentulous patients in the United States. It is also known that maxillary edentulism is more common than mandibular edentulism. While the general standard of care for complete tooth replacement in the maxillary arch is the “conventional” complete denture, it is well established that maxillary implant overdenture supported by four implants generally outperforms the conventional denture. The objective of this study is to determine whether placement of a minimal number (2) of implants supporting a maxillary overdenture can result in good implant / prosthesis survival and satisfactory patient satisfaction and quality of life. Positive results from this pilot study can be used to generate hypotheses supporting a larger clinical study that may have an impact in re-defining the minimal intervention necessary for rehabilitation of the edentulous maxilla. We plan to accomplish our objectives by the pursuing the following two specific aims: To generate an estimate of three-year implant and prosthesis success for two-implant retained maxillary complete denture prostheses. The clinical outcomes will be recorded in a descriptive manner for variables including implant survival, surgical complications, radiographic bone levels, plaque index/bleeding index around the im
IRB No. 16-111-1 (Dr. Efthimia Ioannidou, PI): Novel Paradigm to Improve Inflammatory Burden in ERSD
The study proposes to examine, for the first time in dialysis patients, the short and long-term effect of systemic and repeated oral health interventions on inflammation and clinical oral parameters. The ultimate goal of this proposal is to improve access to oral care and quality of life by implementing continuous and repeated in-center oral health programs in dialysis populations.
IRB No. 14-041HO-1 (Dr. Rajesh Lalla, PI): Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)
The ORARAD study is a prospective cohort study to document dental and other oral outcomes in patients who receive radiation therapy as part of treatment for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled nationally over a three year period. Of these, 135 will be enrolled at UCHC. All participants will be seen for the study before starting radiation therapy then at six-month intervals for up to two years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss after radiation therapy. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.