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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. 14-179-1 (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.