Clinical Research Directory

Modulation of Periapical Inflammation Following Nano-sized Intracanal Medication. A Randomized Controlled Clinical Trial

The main cause of endodontic disorders is microbial infection. From the infected pulp tissue, microorganisms can penetrate into the deeper layers of root dentine and propagate a periapical tissue through the apical foramen and lateral canals causing apical periodontitis. Apical periodontitis is an inflammatory condition affecting the periapical area of teeth with a global prevalence of 52% among individuals and 5% at tooth level. At the periapical region, microbes and their products encounter the host immune defense. Innate immune cells combat bacteria through phagocytosis and release anti-microbial substances, while adaptive immune cells initiate both cell-mediated and humoral immune responses. This immune activation also stimulates osteoclasts, leading to bone resorption and creating space for the inflammatory cells' infiltration . During periapical inflammation, immune cells migrate to the periapical area, where they release pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), along with anti-inflammatory cytokines like interleukin-10 (IL-10). These cytokines play crucial roles in modulating inflammation and tissue repair. MicroRNAs (miRNAs) are evolutionarily conserved small (18-22 nucleotides) single-stranded, noncoding RNAs. It has been well acknowledged that miRNAs influence gene expression at the posttranscriptional level by targeting mRNA 3'-untranslated regions (3'-UTRs). Accumulating evidence has suggested that miRNA expression is related to the clinical and biological features of diverse diseases, and they can be potential biomarkers for diagnosis, treatment, and prognosis. miRNAs have revealed their critical roles in regulating various cellular functions, including proliferation, apoptosis, differentiation, metabolism, and tumorigenesis, by targeting specific mRNAs. MiR-146a regulates innate immunity, inflammatory responses, and the antiviral pathway. Changes in miR-146a expression have been noted in many human diseases, including autoimmune disorders and cancers. In addition, miR-146a is an important biomarker of disease diagnosis, prevention, and treatment. It is a negative regulator of inflammatory responses by suppressing target gene expression. However, limited data is available regarding the functional role of miR-146a in modulating the inflammatory response of periapical tissues following root canal disinfection in endodontic retreatment cases. Eliminating microorganisms is the primary objective of root canal therapy in order to create an environment as free of bacteria as possible. However, not all root canal treatments are completely successful, and in some cases, the infection persists leading to development of secondary apical periodontitis in previously treated teeth. Disinfecting the root canal during retreatment is significantly more challenging due to the presence of persistent microorganisms that have settled in the root canal system. These microbes are often resistant to standard irrigations and antimicrobial agents leading to the formation of periradicular lesions. Such bacteria can survive for extended periods around the previously filled root canals. Sodium hypochlorite (NaOCl) is the most widely used irrigant in root canal therapy due to its strong antibacterial effect and its ability to dissolve organic substances. Effective canal cleaning is difficult to achieve without the use of NaOCl at a sufficiently high concentration. However, NaOCl has several drawbacks, including its cytotoxicity which can lead to tissue damage and patient symptoms. Additionally, its strong oxidizing nature negatively affects the mechanical properties of dentin such as microhardness and elastic modulus. NaOCl should be used with caution in endodontic procedures to prevent hypochlorite accidents. Calcium hydroxide (Ca (OH)2) is the most widely utilized intracanal medication. It has the potential to dissolve tissue, acts as a physical barrier and generates hydroxyl ions, creating an extremely alkaline environment. It has been shown to be quite effective in the treatment of teeth with persistent periapical lesions. To provide optimal endodontic treatment, the root canal system should be thoroughly cleaned of soft-tissue debris, smear layer, and bacteria. Nanoparticles (NPs) have unique characteristics such as smaller sizes, increased surface area to volume ratio, and higher chemical reactivity and charge density leading to greater interaction with the environment and negatively charged bacterial cells, compared to their bulk counterparts. These advantages can be used to design highly anti-microbial agents with maximal therapeutic efficacy and minimal side effects.

CBD Knee Scope Study

This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

Suzetrigine Post DIEP

This research study is being conducted to see whether adding suzetrigine (Journavx), an FDA-approved non-opioid pain medication, to the standard Enhanced Recovery After Surgery (ERAS) pain management protocol can improve pain after surgery. This is to see if we can decrease the use of opioids, since Journavx works on nerve cells outside of the brain to block pain signals and has no addictive potential. Patients will be provided suzetrigine at a pre-operative clinic visit before you come for surgery so they will have it available during your hospital stay. Oral morphine equivalents will be calculated during the inpatient and outpatient duration to assess if individuals who are assigned to the suzetrigine group have decreased use of opioids compared to the non-suzetrigine patient groups. The hypothesis is that suzetrigine will allow for decreased opioid usage.

A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery

The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent clinical and/or demographic factors. No control group is necessary.

Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.

Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth.

The aim of the present study will compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?

Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy

This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

The main question this randomized control trial aims to answer is: • Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery. Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.

Dextenza in the Post-op Management of Vitreoretinal Surgeries

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

QL vs LAI for Palatoplasty

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

TAP Block: Does Volume Make a Difference?

Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis

The aim of this study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and Methods:A total of 99 mandibular premolar and molar teeth will be included in this study. The teeth will be randomly allocated into three groups (n = 33 per group): total pulpotomy, radicular pulpotomy, and root canal treatment.Root canal treatment will be performed using standardized endodontic protocols.Total pulpotomy will be carried out to the level of the canal orifices, followed by hemostasis achieved with 2.5% sodium hypochlorite (NaOCl). A 3-mm-thick layer of mineral trioxide aggregate (MTA) will be placed as the pulpotomy material.Radicular pulpotomy will be performed by removing the pulp tissue a few millimeters apical to the canal orifices. Hemostasis will be achieved using 2.5% NaOCl, and a 3-mm-thick layer of MTA will be placed as the pulpotomy agent.All treated teeth will be restored with glass ionomer cement, followed by a composite resin restoration.Postoperative pain intensity will be assessed using a visual analog scale (VAS) at the following time points: preoperatively, and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success and periapical health.

Opioid Use After Laparoscopic Salpingectomy

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.

Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery

This is prospective, randomized study. The purpose of this study is to evaluate whether the addition of Suzetrigine to well established multimodal pain regimen for participants undergoing bariatric patients undergoing weight-loss surgery and cardiac patients undergoing sternotomy will reduce post-operative opioid consumption and pain scores.

PAIN OUT: Improvement in Postoperative PAIN OUTcome

PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

CPL-01 in the Management of Postoperative Pain After Bunionectomy

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.

Dextromethorphan for Treatment of Postoperative Pain

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

Force Sensor Study

This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries. For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively. For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.

Post-operative Cesarean Trial of Pain Control

This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.

Temperature Rise Caused by Short or Long-wavelengths

Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. This study aims to specifically measure the in vivo temperature rise in simulated restorative procedures using blue light (standard) and red light and its post-operative sensitivity rates.

Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia

The goal of this observational study is to learn about the long-term effects of microvascular decompression (MVD) in patients with trigeminal neuralgia (TN). The main question it aims to answer is: Does undergoing post-operative dental treatment or other orofacial stimulation increase the likelihood of pain relapse after MVD for TN? Participants who have previously undergone MVD for TN as part of their standard medical care will be asked to complete surveys over phone call. These surveys will focus on their pain experiences, timing, anxiety attacks and nature of any pain relapses, and whether they have received dental treatments or other orofacial interventions during follow-up.

Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy

Minimally invasive applications are seen as the gold standard in today's gynecology practice and are frequently preferred by both patients and physicians. Less pain, shorter hospital stays, and better cosmetic results brought about by minimally invasive applications further increase their preference. One of these approaches is hysteroscopic interventions. Although hysteroscopy is a well-defined method, current research has focused on further reduction of pain. One of these methods is to warm the distention media at body temperature. theTaim of this study was to examine the effect of distention medium temperature on image quality, hyponatremia risk, and post-operative pain in operative hysteroscopy.