21 Clinical Trials for Various Conditions
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective. It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.
The goal of this study is to conduct a feasibility open pilot study (N=Up to 20) with exit interviews to assess the feasibility, acceptability, and credibility of the study protocol and Face-Forward-Web; a web-based mind-body intervention for adult patients with COP. Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention methodology in preparation for a future efficacy study. This research leverages mixed methods information to evaluate the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention and study methodology in preparation for the subsequent pilot study and again later, for a pilot feasibility randomized control trial (RCT).
This clinical study aims to compare the efficacy of two brief psychological interventions: Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions (local myalgia, myofascial pain, centrally mediated myalgia) in a tertiary orofacial pain clinic. It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome.
Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls.
Purpose: Primary: To evaluate the efficacy of extended-release (ER) propranolol compared to placebo in the reduction of a pain index in patients with temporomandibular disorder (TMD). Secondary: To determine if extended-release propranolol efficacy varies according to participants' catechol-O-methyltransferase (COMT) genetic polymorphisms and to investigate the efficacy of extended-release propranolol compared with placebo using secondary endpoints. Exploratory: To investigate whether the efficacy of extended-release propranolol in the reduction of the pain index varies according to participants' polymorphisms in 3 other genetic regions and according to various phenotypic characteristics. Participants: 200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind fashion, to receive either extended-release propranolol or placebo at one of three study sites: University of North Carolina-Chapel Hill School of Dentistry; University of Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo School of Dental Medicine. Procedures (methods): Randomization will be to either propranolol or placebo. The 10-week study treatment period is divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits over 12-15 weeks as follows: screening and baseline visit (Visit \[V\] 0, 7-21 days prior to V1); randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2 (V2, 1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization, study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after drug tapering ends, study day 77 +/- 7). Depending on the visit, procedures will include: reviews of medical history, weekly alcohol consumption, concomitant therapies and medications, adverse events, compliance, and eligibility; administration/review of questionnaires; blood draw; pregnancy test in women of childbearing potential; and dispensing of study drug.
The purpose of this study is to examine the effects of a hope-based intervention on clinical and experimental pain in individuals with temporomandibular disorder (TMD). To examine the effectiveness of this intervention, a two-arm randomized trial will be conducted with 50 individuals, between the ages of 18 and 65, who have TMD.
Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.
This is a proposal for an administrative supplement to the parent study, "Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism" (U01 DE028520). The parent study is currently engaged in exploring the extent to which the training of coping skills per se is an important mechanism of psychosocial treatment. The current project seeks to lay the groundwork for expanding the range of treatment mechanisms examined to include therapeutic relationship factors (therapist support, empathy, acknowledgment). The present supplemental study will provide instruction for individual patient pain management via an online application, with no therapist or counselor assistance. The aim is to determine the extent to which treatment-related outcomes (including adherence and pain) may be influenced by therapist support factors.
This description observational research is comparative in design, that is comparing existing standard clinical dental images, not obtained in this study, to test (i.e., ddMRI) images. The standard clinical dental images consist of radiographs, such as bitewings, periapical, panoramic, cone-beam CT, and medical CT, as well medical MRIs of the temporomandibular joints (TMJ).The conceptualization of research questions, study designing, and interpretation of imaging data has and will involve content expertise in all ddMRI research.
Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants.This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. TMD patients (N=160) will be randomized to receive standard care (STD) + an individualized assessment and treatment program (IATP) or to standard care + conventional cognitive-behavioral treatment (STD+CBT). It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes.
The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research project targets patients with chronic constant facial pain and excludes patients with primarily paroxysmal pain.
Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.
The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.
Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who seek care for one of these conditions, will go on to develop chronic pain. The two most common TMD conditions include myofascial pain disorder and internal derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam or test to differentiate between these two conditions. Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting for the majority of the patients afflicted, with a small minority progressing to advanced joint destruction, disability and chronic pain.18 Currently there are no prognostic indicators to identify these individuals. There are three hypothesis of degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching or grinding by the patient and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as recently demonstrated in several pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique advantage of showing active disease before anatomic damage is evident. Our hypothesis is that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.
This is a case control study of the association between burning mouth syndrome and sleep dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible. Each case and control subject will be administered the following 4 questionnaires by interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of oral symptoms. Cases (BMS patients) will be followed in the clinic or by telephone contact once per month for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be administered by interview.
This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain and spinal nerve cells that may cause the cells to produce electrical discharges and pain. Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and psychiatric evaluation. These results will serve as baseline values for participants. Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows: Dextromethorphan In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety drug) separately in two 6-week periods. (Lorazepam is used in this study as an "active placebo" for comparison with dextromethorphan. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug.) They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest dose that does not cause troubling side effects) and will stay on that dose for the remaining 2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either drug may continue with Part 2 of the study, which compares these two drugs four more times to confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks. This procedure will be repeated eight times. Throughout the study, patients will keep a daily pain diary. They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who live more than a few hours' drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits. Topiramate Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan, with the following exceptions. They will take topiramate and an inactive placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods. Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period. Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased. Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years. Those who continue for this phase will take topiramate for the 2-year period. They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit.
This study provides a mechanism for evaluating patients for possible participation in NIDCR clinical research studies. NIDCR studies involve three major areas-pain, neurosensory mechanisms, and pain-relieving drugs-all of which have specific requirements and patient characteristics. No treatment is offered under this protocol; it is intended to facilitate patient recruitment into NIDCR studies. Patients with unusual or unknown conditions that have or have not been diagnosed may be eligible for this screening study. Specific medical criteria for enrollment vary with the particular protocol for which the individual is being screened. Medical and dental histories will be obtained and participants will have a dental examination. Diagnostic procedures will be done in accord with standard medical and dental practice and may include X-rays, blood tests, and routine urinalysis, as appropriate. Participants found eligible for an active study may enroll in that study. Those who are not eligible for a current study may be re-evaluated for future studies within a year if they wish. After 1 year, participants for whom no appropriate studies are identified will be referred back to their primary doctor or referring physician or dentist.
Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.
This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.