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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. 09-010-1 (Dr. Rajesh Lalla, PI): Oral Mucositis Research Registry/Repository

Oral Mucositis refers to mouth sores that occur in cancer patients due to the chemotherapy or radiation therapy that they receive. The Oral Mucositis Research studies related to oral mucositis or cancer and to identify potentially eligible subjects for future research. The Oral Mucositis Research Repository will hold in an identifiable format, any remaining tissue or blood samples or derivatives thereof for use in oral mucositis or cancer studies, at the conclusion of the study for which they were collected.

IRB No. 20-045-2 (Dr. Mark Litt, PI): Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism

The goal of this research is to determine which of the two treatments described below is more effective for helping patients manage their orofacial pain problem. Each treatment will involve 6 individual outpatient sessions with a pain therapist, each session being about one hour (except the first, which will take longer). About 160 participants will be recruited. Eligible persons will be those who have indicated they have a significant orofacial pain problem, such as pain in the area of the temporomandibular joint, that has lasted at least 3 months, and for which they wish to be treated. 160 patients with TMD-related orofacial pain of at least 3 mo duration will be assigned to 1 of 2 treatments. A highly individualized 6-session coping skills treatment based on Experience Sampling (ES) records of pain, thoughts, feelings and behaviors (Individualized Assessment and Treatment Program; IATP) will be compared to a 6-session conventional cognitive-behavioral coping skills training treatment (CBT) that does not involve close individualization of treatment. Patients in both treatments will participate in periods of experience sampling (ES) prior to and following treatment. For those in IATP, however, the ES records will help determine the patient's specific strengths, coping deficits, and situational triggers for pain to be examined in treatment. Those in CBT will receive training in a common set of skills considered important for pain control. Both treatments will be supported by Standard Care (STD: NSAIDs, soft diet, maxillary splint). Follow-ups will be administered out to 12 months post intake. Primary outcomes will be Pain, Depression symptoms, and Pain-related interference with functioning. Secondary outcomes will include physical and emotional functioning and ratings of improvement. Process or mediator variables will include within-day recordings of coping behavior and self-efficacy.

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.

IRB No. 24-204-2 (Dr. Niloufar Azami, PI): A novel approach to integrate 3D facial and intraoral scans and its potential application in investigating soft tissue response in orthodontic treatment.

Master Lay Summary: This research is being done to develop a new way to combine digital dental molds with 3D facial photos and therefore to investigate the facial soft tissue changes during orthodontic tooth movement at UConn Health/SODM. The digital dental molds will be obtained by providers using an intraoral scanner without ionizing radiation. At the same visit, the 3D facial photos will be taken by providers using a 3D camera system without radiation. The digital dental mold will be combined with 3D facial photos by two different methods: one method by using anterior dental landmarks as references, which is a published method; the other by using orthodontic arch wires as references, which is the one we proposed. Results from the two methods will be compared to test the reliability of the new method. To better understand how orthodontic tooth movement can affect the facial tissues (e.g., lips), researchers will repeat the same study procedures (both digital dental molds and 3D facial photos) at three consecutive orthodontic routine visits. After obtaining all the data, the researchers will combine all the images to investigate the relationship between tooth movement and soft tissue changes during these three orthodontic time points. Participants have braces fit to their teeth and anticipate some retraction of their front teeth as part of the orthodontic treatment plan. The only difference between the standard of care and this study is that participants will receive intraoral scans and facial scans during three orthodontic routine visits in addition to their regular treatment. The duration of the whole study for each participant can be up to 15-16 weeks. The study will begin from the time when participants receive retraction of their upper anterior teeth (front teeth) as part of their orthodontic treatment. Study visits will be scheduled on dates of routine orthodontic appointments with the addition of 15-20 minutes to each orthodontic appointment depending upon the sample collection procedures. The second study visit will be 4~7 weeks after the first study visit. The third study visit will be 12~15 weeks after the first one. The information to be collected by the researchers may lead to a better understanding of how orthodontic treatment can affect facial esthetics and therefore better esthetic results from orthodontic treatment in 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). Recording of the dental molds obtained with an intraoral digital scanner or recording of facial soft tissues with a hairband are slightly uncomfortable for some patients; 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. Hypotheses, Aims, and Objectives: Hypothesis: Null Hypothesis Primary Outcome: develop a new method of combining digital dental molds with 3D facial photos. We hypothesize that there is no significant difference between the new method and the published method of combining digital dental molds with 3D facial photos. Secondary Outcome: investigate the correlation between orthodontic tooth movement and facial soft tissue changes during orthodontic treatment. We hypothesize that there is no correlation between orthodontic tooth movement and facial soft tissue changes during the study visits. Alternative Hypothesis There is a significant difference between the two methods of combining digital dental molds and 3D facial photos. There is a relationship between orthodontic tooth movement and facial soft tissue changes during the study visits. Aims/objectives: To compare the two methods of combining dental molds with 3D facial photos. To investigate the relationship between orthodontic tooth movement and facial soft tissue changes during the treatment.

IRB No. 25-363-2 (Dr. Prazwala Chirravur, PI): The Effect of Dietary Xylooligosaccharides (XOS) on the Composition of the Human Oral Microbiome

SPECIFIC AIM: To assess the modulatory effect of dietary xylooligosaccharides (XOS) on the composition of the human oral microbiome .

IRB No. 26-046-2 (Dr. Flavio Uribe, PI): A Weekly Assessment of Canine Retraction with Elastomeric Chains and Nickel-Titanium Coil Springs Using Dental Monitoring Technology: A Split-Mouth Randomized Clinical Trial

Rationale for this study: The proposed study aims to fill a gap in the current literature by providing a high-resolution analysis of weekly canine retraction using dental monitoring technology. Conducting a study that directly measures tooth movement on a weekly basis would fill this critical gap by providing high-frequency data on the progression of space closure. Previous studies have evaluated the effectiveness of elastomeric chains and NiTi coil springs in space closure, but they have primarily relied on periodic in-office measurements, which may not capture the dynamic nature of tooth movement. By incorporating remote monitoring, this study will enable a more precise assessment in 3D of tooth displacement over time, offering insights into the behavior of tooth movement with different systems. Such an approach would allow for a more precise understanding of the short-term effects of different force delivery systems, force decay patterns, and biological variability, ultimately improving the evidence base for clinical decision-making in orthodontics. Canine retraction is a fundamental phase of orthodontic treatment, especially after premolar extraction. Two primary methods used are nickel-titanium (NiTi) coil springs and elastomeric chains, which differ in biomechanical efficiency and force degradation. Despite their widespread use, there is a lack of high-frequency clinical data describing the weekly pattern of tooth movement and molar anchorage loss using these systems. Study Design: This is a split-mouth randomized clinical trial. Each patient receives NiTi coil spring retraction on one side and elastomeric chain retraction on the other. Tooth movement is measured both in-clinic (iTero® Lumina™ scanner) and remotely (DM app) over 12-13 weeks. Study Population and Sample Size: A total of 20 orthodontic patients, aged 18-45 years, requiring bilateral maxillary first premolar extractions will be recruited from the UConn Health orthodontic clinic. Power analysis based on prior data supports this sample size. Major Study Interventions: All participants receive standard orthodontic treatment. At the start of the study (T0), retraction force of 150g is applied to the maxillary canines using NiTi coil springs on one side and elastomeric chains on the other (randomized). Intraoral digital scans are captured at T0, T1 (4-5 weeks), T2 (8-9 weeks), and T3 (12-13 weeks). Weekly at-home DM scans are also submitted by patients using the ScanBox and app. Hypotheses, Aims, and Objectives: Hypothesis: Null Hypothesis Primary Outcome: Weekly rate of canine retraction evaluated in 3D with 6 degrees of freedom. There is no significant difference in the weekly rate of canine retraction and in all 3 dimensions between nickel-titanium (NiTi) coil springs and elastomeric chains as measured using DM technology. Secondary Outcome: Weekly movement rate of maxillary molar displacement in 3D evaluated with 6 degrees of freedom, plaque accumulation and oral hygiene status. There is no significant difference in the magnitude of molar displacement in 3D evaluated with 6 degrees of freedom. There is no difference in plaque accumulation and oral hygiene status between NiTi coil springs and elastomeric chains. Alternative Hypothesis There is a significant difference in the weekly rate of canine retraction evaluated in 3D with 6 degrees of freedom between nickel-titanium (NiTi) coil springs and elastomeric chains as measured using Dental Monitoring technology. Aims/objectives: To compare the weekly rate of canine retraction evaluated in 3D with 6 degrees of freedom between NiTi coil springs and elastomeric chains using Dental Monitoring technology. To compare the weekly rate of molar displacement evaluated in 3D with 6 degrees of freedom between NiTi coil springs and elastomeric chains using Dental Monitoring technology. To compare plaque accumulation and oral hygiene status with NiTi coil springs versus elastomeric chains.