Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial.

BACKGROUND: Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal disorders, but a lack of well-designed randomised controlled trial s (RCTs) mean there is insufficient evidence to prove the efficacy of HPP. METHODS: This study is a two-arm parallel, assessor-blinded, multi-centre, randomised controlled trial. We will enrol 82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be four follow-up visits 6, 9, 13, and 25 weeks from baseline. The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6. Secondary outcomes will be Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck's Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment). DISCUSSION: This study will assess the efficacy and safety of HPP for chronic TMD compared with PT. This RCT will provide evidence for the efficacy, safety, and economics of HPP. TRIAL REGISTRATION: clinicaTrials.gov (NCT04087005) / Clinical Research Information Service (CRIS) (KCT0004437) / IRB (JASENG 2017-09-002-002, KHNMCOH 2019-08-002) / Ministry of Food and Drug Safety (No. 31886).

Outcome of three screening questions for temporomandibular disorders (3Q/TMD) on clinical decision-making.

Patients with temporomandibular disorders (TMD) seem to go undetected and not adequately managed within dentistry. To identify these patients, three screening questions (3Q/TMD) have been introduced within dentistry in parts of Sweden. It is not known whether 3Q/TMD affects the clinical decision-making for these patients. The aim of this study was to evaluate the outcome of 3Q/TMD on the clinical decision-making and to analyse whether gender, age and the fee system the individual was assigned to were related to prescribed TMD treatment. This cohort study was carried out within the Public Dental Health service in Västerbotten, Sweden. As part of the routine dental check-up, a health declaration including 3Q/TMD was completed. The study population was randomly selected based on their 3Q/TMD answers. In total, 300 individuals with an affirmative answer to any of the 3Q/TMD, and 500 individuals with all negative answers were selected. The 3Q/TMD includes questions on weekly jaw-face-temple pain (Q1), pain on function (Q2) and catching/locking of the jaw (Q3). The 3Q/TMD was analysed in relation to prescribed treatment assessed from dental records. There was significantly more treatment performed or recommended for 3Q-positives (21·5%), compared to 3Q-negatives (2·2%) (P < 0·001). The odds ratio for TMD-related treatment for 3Q-positives versus 3Q-negatives was 12·1 (95% CI: 6·3-23·4). Although affirmative answers to the 3Q/TMD was related to TMD treatment, the majority of individuals with a screen positive still did not, according to dental records, receive assessment or treatment. Further studies are needed to better understand the clinical decision-making process for patients with TMD.

Validity of three screening questions (3Q/TMD) in relation to the DC/TMD.

Temporomandibular disorders (TMD) are common but seem to be largely undetected within general dental care. To improve dentists' awareness of these symptoms, three screening questions (3Q/TMD) have been introduced. Our aim was to validate 3Q/TMD in relation to the diagnostic criteria for TMD (DC/TMD), while taking into account the severity level of the symptoms. The study population consisted of 7831 individuals 20-69 years old, who had their routine dental check-up at the Public Dental Health Service in Västerbotten, Sweden. All patients answered a health declaration, including the 3Q/TMD regarding frequent temporomandibular pain, pain on movement and catching/locking of the jaw. All 3Q-positives (at least one affirmative) were invited for examination in randomised order. For each 3Q-positive, a matched 3Q-negative was invited. In total, 152 3Q-positives and 148 3Q-negatives participated. At examination, participants answered 3Q/TMD a second time, before they were examined and diagnosed according to DC/TMD. To determine symptom's severity, the Graded Chronic Pain Scale and Jaw Functional Limitation Scale-20 (JFLS-20) were used. In total, 74% of 3Q-positives and 16% of 3Q-negatives met the criteria for DC/TMD pain or dysfunction (disc displacements with reduction and degenerative joint disorder were excluded). Fifty-five per cent of 3Q-positives had a TMD diagnosis and CPI score ≥3 or a JFLS-20 score ≥5, compared to 4% of 3Q-negatives. The results show that the 3Q/TMD is an applicable, cost-effective and valid tool for screening a general adult population to recognise patients in need of further TMD examination and management.

Temporomandibular disorders/myoarthropathy of the masticatory system. Costs of dental treatment and reimbursement by Swiss federal insurance agencies according to the Health Care Benefits Ordinance (KLV).

The goal of the study was to calculate the direct costs of therapy for patients with MAP. This retrospective study included 242 MAP patients treated at the Department of Prosthodontics of the University of Bern between 2003 and 2006. The following parameters were collected from the clinical charts: chief complaint, diagnosis, treatment modalities, total costs, costs of the dental technician, number of appointments, average cost per appointment, length of treatment, and services reimbursed by health insurance agencies. The average age of the patients was 40.4 ± 17.3 years (76.4% women, 23.6% men). The chief complaint was pain in 91.3% of the cases, TMJ noises (61.2%) or limitation of mandibular mobility (53.3%). Tendomyopathy (22.3%), disc displacement (22.4%), or a combination of the two (37.6%) were more often diagnosed than arthropathy alone (7.4%). Furthermore, 10.3% of the MAP patients had another primary diagnosis (tumor, trauma, etc.). Patients were treated with counseling and exercises (36.0%), physiotherapy (23.6%), or occlusal splints (32.6%). The cost of treatment reached 644 Swiss francs for four appointments spread over an average of 21 weeks. In the great majority of cases, patients can be treated with inexpensive modalities. 99.9% of the MAP cases submitted to the insurance agencies were reimbursed by them, in accordance with Article 17d1-3 of the Swiss Health Care Benefits Ordinance (KLV) and Article 25 of the Federal Health Insurance Act (KVG). The costs of treatment performed by dentists remain modest. The more time-consuming services, such as providing information, counseling and instructions, are poorly remunerated. This aspect should be re-evaluated in a future revision of the tariff schedule.

Study methods, recruitment, sociodemographic findings, and demographic representativeness in the OPPERA study.

UNLABELLED: This paper describes methods used in the project "Orofacial Pain Prospective Evaluation and Risk Assessment" (OPPERA) and evaluates sociodemographic characteristics associated with temporomandibular disorders (TMD) in the OPPERA case-control study. Representativeness was investigated by comparing sociodemographic profiles of OPPERA participants with population census profiles of counties near study sites and by comparing age and gender associations with TMD in OPPERA and the 2007 to 2009 US National Health Interview Survey. Volunteers aged 18 to 44 years were recruited at 4 US study sites: 3,263 people without TMD were enrolled into the prospective cohort study; 1,633 of them were selected as controls for the baseline case-control study. Cases were 185 volunteers with examiner-classified TMD. Distributions of some demographic characteristics among OPPERA participants differed from census profiles, although there was less difference in socioeconomic profiles. Odds of TMD was associated with greater age in this 18 to 44 year range; females had 3 times the odds of TMD as males; and relative to non-Hispanic-Whites, other racial groups had one-fifth the odds of TMD. Age and gender associations with chronic TMD were strikingly similar to associations observed in the US population. Assessments of representativeness in this demographically diverse group of community volunteers suggest that OPPERA case-control findings have good internal validity. PERSPECTIVE: Demographic associations with TMD were consistent with population benchmarks and with other studies, suggesting broad applicability of these OPPERA findings. Greater occurrence of TMD in non-Hispanic-Whites than in other racial/ethnic groups and the lack of a socioeconomic gradient contradicts the disparities seen in many other health conditions.

Occlusion and temporomandibular disorders: a malpractice case with medical legal considerations.

Occlusion and temporomandibular The issue of temporomandibular disorders (TMD) diagnosis and treatment has become a matter of increasing interest in the medical legal field in recent years. The old-fashioned theories based on the occlusal paradigm was proven to be erroneous, and clinicians who still provide irreversible treatments to TMD patients have to be conscious of the potential legal consequences of their behavior. The present paper described an illustrative case report of a patient to whom extensive and irreversible occlusal therapies were performed with the unique aim to provide relief from TMD symptoms. The treatment was unsuccessful and the dental practitioner was called into cause for a professional liability claim. The clinician was judged guilty of malpractice on the basis of the lack of scientific evidence of the irreversible occlusal approaches to TMD, which were erroneously used and did not give the patient any benefit, thus forcing him to a non necessary financial and biological cost. The failure to satisfy the contract with the patient, which is usually not covered by any insurance company, forced the practitioner to give the money back to the patient. The ethical and legal implications of such case were discussed, with particular focus on the concept that medical legal advices need to satisfy the highest standards of evidence and have to be strictly based on scientific knowledge.

Cost-effectiveness of treatments for temporomandibular disorders: biopsychosocial intervention versus treatment as usual.

BACKGROUND: The authors conducted a randomized clinical trial to evaluate the cost-effectiveness of a biopsychosocial intervention with patients who are at high risk (HR) of progressing from acute to chronic TMD-related pain. METHODS: The authors classified 96 patients with acute TMD (less than six months' duration) as HR according to a predictive algorithm and randomized them into an early intervention (EI) or a nonintervention (NI) group. The NI group received a biopsychosocial treatment that included cognitive behavioral skills training and biofeedback. Both groups were followed up for one year. The authors collected TMD cost data throughout the year. RESULTS: The authors found that the EI group spent significantly fewer jaw-related health care dollars, relative to the NI group, from intake to the one-year follow-up. CONCLUSION AND CLINICAL IMPLICATIONS: The reduced jaw-related health care expenditures for patients in the EI group compared with expenditures for patients in the NI group at one year suggest that an early biopsychosocial intervention is a cost-effective measure in dealing with often unnecessarily costly TMD-related pain.

The efficacy of traditional, low-cost and nonsplint therapies for temporomandibular disorder: a randomized controlled trial.

BACKGROUND: Treatment recommendations for patients with painful temporomandibular disorders (TMDs) range from conservative treatments such as physiotherapy to aggressive and irreversible treatments such as restorative reconstruction and joint surgery. METHODS: The authors randomized 200 subjects diagnosed with TMD into three groups: usual conservative, dentist-prescribed self-care treatment without any intraoral splint appliance (UT); UT plus a conventional flat-plane hard acrylic splint (HS); and UT plus a soft vinyl (a low-cost athletic mouth guard) splint (SS). Subjects completed questionnaires and clinical examinations at three, six and 12 months. RESULTS: The authors observed no significant differences among the groups in TMD-related pain levels or other common signs and symptoms of TMD at baseline (BL) or at any follow-up. The changes from BL were comparable for all three groups. The authors did not note any significant differences at any follow-up for compliance with study protocols or for occurrences of adverse effects from either splint type. For HS versus SS, there were significant differences in rates of splint use, but these differences were not accompanied by differences in either self-reported symptoms or in clinical findings. CONCLUSIONS: All patients improved over time, and traditional splint therapy offered no benefit over the SS splint therapy. Neither splint therapy provided a greater benefit than did self-care treatment without splint therapy. CLINICAL IMPLICATIONS: These findings suggest that clinicians who treat patients with TMD should consider prescribing low-cost nonsplint self-care therapy for most patients.

Reduction in sick leave and costs to society of patients with Meniere's disease after treatment of temporomandibular and cervical spine disorders: a controlled six-year cost-benefit study.

This study compares the frequency of sick leave between the three-year period after and the three-year period before coordinated treatment of temporomandibular and cervical spine disorders in 24 patients (ten males and 14 females) diagnosed with Meniere's disease. The frequency of sick leave for the patients was also compared with the frequency of sick leave in a control group from the population. A cost-benefit analysis was made regarding the costs to society of sick leave related to the treatment costs of the patients. In a previous study the same patients were treated for their severe signs and symptoms of temporomandibular and cervical spine disorders, and they reported a substantial reduction in their vertigo, non-whirling dizziness, tinnitus, feeling of fullness in the ear, pain in the face and jaws, pain in the neck and shoulders, and headache. The number of days of sick leave and the year the patient began to receive disability pension due to the symptoms of Meniere's disease were obtained from the National Health Insurance Service in Sweden. Two of the patients received disability pension benefits due to Meniere's disease 17 years prior to their normal retirement pension. A third patient received disability pension for another reason and two were receiving a retirement pension. Data on the remaining 19 patients showed a considerable reduction in number of days of sick leave during the three-year period after coordinated treatment (270 days) compared with the three-year period before the treatment (1,536 days). The control subjects used a total of 14 days sick leave for the same symptoms during the same six-year period. Vertigo (nine days) was the dominant cause followed by pain in the neck and shoulders, and headache. The reduction in sick leave for the 19 nonretired patients and the treatment costs for the 24 patients can be used for a simple cost-benefit calculation for the subgroup of nonretired patients. During the first three years after treatment the reduction in sick leave was on average 66.6 days for each of the 19 nonretired patients. Within the limits of this study, it can be concluded that the costs to society for sick leave and disability pension due to Meniere's disease are substantial. A coordinated treatment of temporomandibular and cervical spine disorders appears to substantially reduce these costs.

Health care utilization and cost among health maintenance organization members with temporomandibular disorders.

AIMS: Little has been reported on the use of health care services and consequent costs among persons with temporomandibular disorders (TMD). This project compared the use and cost of medical and dental care services for TMD patients and matched comparison subjects. METHODS: Patients were continuously enrolled members of Kaiser Permanente Northwest Division who had at least 1 TMD Clinic visit or TMD-related procedure between January 1990 and December 1995 (n = 8,801). An equal number of comparison subjects were identified electronically and matched on 14 variables, including age and gender. Utilization and cost estimates were determined and compared for selected medical and dental services. RESULTS: For both groups, the mean age was about 40.5 years, and approximately 80% were female. The TMD subjects used significantly more services than did comparison subjects and had mean costs that were 1.6 times higher for all services. Outpatient visits accounted for about 40% of the difference in mean costs. About 10% of TMD subjects and comparison subjects accounted for about 40% and 47% of the costs in each group, respectively. Female TMD subjects and comparison subjects had higher costs than their male counterparts, and male TMD subjects had higher costs than female comparison subjects. CONCLUSION: Patients with TMD used more of all types of services and had higher costs. A small proportion of the subjects accounted for a large proportion of the costs. Gender was an important factor in utilization and cost. Utilization and cost differences were consistent over a wide range of service categories and could not be explained by TMD alone.

Prediction of treatment-seeking behavior in acute TMD patients: practical application in clinical settings.

AIMS: To determine potential differences in predictive models of acute temporomandibular disorder (TMD) patients divided into groups based on the physiologic characteristics of their TMD. METHODS: One hundred seventy-seven acute TMD patients were evaluated with an extensive battery that included biologic and psychosocial measures. Subjects were separated into 3 groups based on a physical exam using the Research Diagnostic Criteria for TMD (RDC): those with a myofascial pain diagnosis, those with either a disc displacement or other joint condition, and those who reported pain but did not receive an RDC Axis I diagnosis. Six months later, it was determined whether patients had sought additional treatment for relief of their symptoms. Treatment-seeking and non-treatment-seeking groups were compared for significant differences, and predictive models were generated to determine the array of variables that best predicted treatment-seeking behavior among each of the 3 classifications of TMD patients used in this study. RESULTS: Among patients with a diagnosis of myofascial pain, gender, Multidimensional Pain Inventory (MPI) interference score, and MPI affective distress score accurately predicted treatment-seeking behavior in 76.1% of the sample. For patients with a diagnosis of disc displacement, arthralgia, arthritis, or arthrosis, the following variables predicted treatment utilization behavior in 93.6% of the sample: race, RDC graded chronic pain, and the introversion scale of the Minnesota Multiphasic Personality Inventory-2. For patients with no RDC Axis I disorder, 80.5% of the sample was accurately classified with regard to treatment-seeking behavior through the use of only the characteristic pain intensity score (i.e., mean of visual analog scale scores for "pain right now," "worst pain," and "average pain"). CONCLUSION: The factors that predict which acute TMD patients are most likely to seek additional treatment vary depending on the physiologic basis of their TMD. This suggests that acute TMD patients may benefit from different modalities of treatment, depending on the type of TMD with which they present.

Rising costs lead to DM program aimed at TMD.

Pain and other symptoms associated with the jaw are nothing new, but some health care organizations have noticed that costs and complaints related to these problems are on the rise, and there continues to be controversy over where such problems belong: in the hands of a dentist or a physician. Further, many experts believe patients with TMD are too often treated more aggressively than need be, and that a step-by-step approach, emphasizing conservative strategies first, is long overdue.