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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. 07-016-1 (Dr. Martin Freilich, PI): Osteoporosis and bone augmentation/implant outcomes: An observational study
The objective of this study is to utilize a clinical study model to collect descriptive data needed to support the development of future studies that will test the association between specific measures of bone health and the successful integration of new bone from bone augmentation procedures. Postmenopausal women with a wide range of bone health and reduced jaw bone thickness will receive bone augmentation therapy followed by implant and restoration placement, with the specific treatment based upon best clinical judgment. Throughout initial diagnosis, treatment and follow-up, blood makrers will be drawn to assess bone health and its possible association with treatment outcomes. Outcomes will be based upon clinical and radiographic examination, bone health markers and patient interviews.
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. 22-314-2 (Dr. Flavio Uribe, PI): A Randomized Clinical Trial Comparing the Effect of Force Magnitude on the Rate of Canine Retraction and Gingival Crevicular Fluid Proteome Profile
lay Summary:. This research is being done to examine the effect of force level in orthodontic treatment plans here at UConn Health/SODM. Force level is the amount of force the orthodontic devices are putting on your teeth for movement. To better understand the effects of force levels, information is collected. Researchers will also collect the fluid that naturally releases from your gums, dental molds obtained with an intraoral digital scanner, picture (x-ray) of specific teeth to evaluate the eye tooth region on the upper jaw on both sides, during orthodontic treatment. Participants are having teeth removed and braces fit to their teeth for orthodontic treatment. The only difference bewtween standard of care and this study is that when the remaining teeth are pushed together to fill the space left by removing some teeth the braces will put about two and one half times as much pressure on half of their teeth as is usually used. This pressure will be applied with the braces remaining on for up to 17 weeks. Treatment will be starting from pulling back your eye teeth for 16-17 weeks to close the space of the pulled out upper premolars. The premolars are the teeth behind to the eye teeth. The space provided by the pulled out premolars will be closed by the pressure behind the back of the eye teeth in the upper jaw. Study visits will be scheduled on dates of routine orthodontic appointments with the addition of 20- 45 minutes to each orthodontic appointment depending upon the sample collection procedures. Only one appointment will be scheduled 1-2 weeks after the first appointment, and the other four appointments will be four weeks apart. The right and left sides will be randomly selected for high or low pulling forces. A high force is considered when an orthodontic force of more than 200 grams is being used to move an eye tooth back. Low pulling forces, or conventional force level is approximately 150 grams to move an eye tooth back. The researchers will decide this after you (your child) decide to join. You (your child) choose from a bunch of closed envelopes assigning one side for the light pulling force and the opposite side for the heavy force. The fluid that naturally releases from your gums and dental molds obtained with an intraoral digital scanner, and periapical radiographs of upper jaw eye teeth (x-rays) are obtained. The information to be collected by the researchers may lead to better and/or quicker treatment results for others in the future. All those who participate in this study will receive standard care in the UConn Health/School of Dental Medicine Orthodontic clinic, which they may benefit from Because of the research activities, there is a slight risk to you (your child) from participating in this research study- (slightly more than braces treatment). Giving the collection of the fluid that naturally releases from your gums or recording of the dental molds obtained with an intraoral digital scanner are slightly uncomfortable for some; you (your child) can take as much time as needed to complete these tasks on research visits. Research procedures will be conducted on the same day and place as your regular care for orthodontic treatment. We will also be taking two periapical radiographs of the eye teeth (two time-points) of the upper jaw region at T0 (The first visit of the study) and T5 (after 16-17 weeks) to better understand the changes in the root length following the course of treatment. This amount of extra x-ray exposure is minimal. Hypotheses, Aims, and Objectives: Hypothesis: Null Hypothesis Primary Outcome: Rate of canine retraction. We hypothesize that there is no significant difference in the rate of canine movement between the light force and the heavy force levels. Secondary Outcome: external apical root resorption (EARR), movement of the anchorage teeth (maxillary first molar), type of canine movement (rotation, extrusion, and tipping), and biomarkers evaluated through GCF. We hypothesize that there is no difference in magnitude of anchorage loss, root length of canines, the type of canine movement, and the expression of biomarkers between light and heavy force levels. Alternative Hypothesis There is a significant difference in the primary outcome (rate of canine retraction) and the supportive outcomes (cytokines and the amount of particular protein/polypeptides/antibody extracted from GCF). Aims/objectives: To compare the effect of light force and heavy force on the rate of orthodontic tooth movement (retraction of maxillary canines). To evaluate the effect of force magnitude on the root length of maxillary canines. To compare the effect of light force versus heavy force on the rate of anchorage teeth movement. To describe the type of canine displacement (degree of tipping, rotation, and extrusion) during space closure with light versus heavy force. To compare the expression of biomarkers with heavy force versus light force.