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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. 15-186-1 (Dr. Efthimia Ioannidou, PI): A PILOT STUDY TO INVESTIGATE THE EFFECT OF VARIOUS CPC CONCENTRATIONS ON GINGIVITIS IN A SPLIT-MOUTH DESIGN
The purpose of this randomized, controlled, parallel arm clinical research study is to assess the effect of anti-plaque mouth rinses on gum disease. To achieve this goal, the study will compare two mouth rinses with different Cetylpyridnicium Chloride (CPC) dose to a negative control (water). CPC is an antiseptic that kills bacteria in the dental plaque. This study will also be evaluating the effect of dental cleaning in combination with CPC.
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.
IRB No. 17-005-3.2 (Dr. Sejal Thacker, PI): IMMEDIATE VERSUS DELAYED LOADING OF TWO IMPLANTS SUPPORTING A LOCATOR RETAINED MANDIBULAR OVERDENTURE – A RANDOMIZED CONTROLLED CLINICAL TRIAL, FOLLOW UP
A RCT was conducted in UCHC from 2009 to 2013, to evaluate the performance of 2 implants that were placed in the lower jaw of completely edentulous subjects to retain a complete mandibular denture. The two implants in the lower jaw were connected to the dentures immediately (on the day of the surgery - immediate loading group) or in a delayed manner (3 months after surgery - delayed loading group). The original trial concluded that Immediate loading of two unsplinted implants supporting a Locator-retained mandibular overdenture seems to be a suitable treatment option. Significantly less radiographic bone loss was observed after 1 year of loading around immediately loaded implants than around delayed loaded implants. The aim of the present study is to evaluate clinically and radiographically the performance of OsseoSpeedTM implants, post-loading supporting a locator retained mandibular overdenture, using either an immediate or delayed loading protocol. Our Hypothesis is that: There is no difference in the evaluated clinical or radiographic parameters on the immediate or delayed loaded implants supporting a locator retained mandibular overdenture at follow up. The primary objective of this study is to evaluate the radiographic bone level change from baseline to follow up between the immediate and delayed loaded implants The secondary objectives of this study are 1. To evaluate cumulative implant survival rate at follow up between immediate and delayed loaded groups 2. To evaluate the condition of the peri-implant mucosa by assessing bleeding on probing, probing depth, and plaque score around the implants 3. To measure the amount of keratinized tissue surrounding the implants and its influence on peri-implant mucosal condition like recession, probing depth, and bleeding on probing 4. To document the nature and frequency of prosthetic complications like chipping of a tooth, fracture of a tooth, or fracture of the denture