Dataset Information

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

ABSTRACT:

Background

This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD).

Methods

This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1-ILIB with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 2-Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 3-Control with no treatment (n = 15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ± 20%, wavelength 808 nm ± 10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures.

Discussion

Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.

SUBMITTER: Sertaje MRF

PROVIDER: S-EPMC9592260 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

Sertaje María Roxana Ferreira MRF Gonçalves Marcela Leticia Leal MLL Gomes Andréa Oliver AO Bruno Laura Hermida LH Fossati Ana Laura AL Viarengo Natalia Osorio NO Santos Elaine Marcilio EM Sobral Ana Paula Taboada APT Mesquita-Ferrari Raquel Agnelli RA Fernandes Kristianne Porta Santos KPS Horliana Anna Carolina Ratto Tempestini ACRT Motta Lara Jansiski LJ Bussadori Sandra Kalil SK

Medicine 20221001 42

<h4>Background</h4>This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD).<h4>Methods</h4>This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, ...[more]

PMID: 36281107

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Project description:BackgroundLoss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non-free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD.ObjectiveThis study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms.MethodsIn this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months.ResultsEthical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.ConclusionsThe purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management.Trial registrationClinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381.International registered report identifier (irrid)DERR1-10.2196/33104.

Project description:Dry needling (DN) is an invasive physiotherapy technique employed for reducing myofascial pain. To compare the effectiveness of dry needling (DN) versus manual therapy (MT) in improving pain, active maximal mouth opening (AMMO) and cervical disability in patients with myofascial pain from temporomandibular disorders (TMDs) were investigated against these treatments. A single-blind, randomized controlled trial was carried out. Individuals (n = 50) with TMDs were randomly allocated in a 1:1 ratio to the DN (n = 25) or MT group (n = 25). Each group received three sessions, separated by 4 days, of either DN or MT. Outcomes were assessed according to pain intensity (Numeric Pain Rating Scale), AMMO (cm), disability (Neck Disability Index), and pressure-pain threshold (PPT) (digital algometry) from the active myofascial trigger points. In both groups, pain and neck disability were significantly lower at the end of treatment compared with those measured at baseline (pain: -2.52 with 95% CI: -3.43 to -1.60 for DN group; pain: -2.92 with 95% CI: -3.77 to -2.07 for MT group; disability: -3.2 with 95% CI: -4.31 to -2.09 for DN group; disability: -2.68 with 95% CI: -3.56 to -1.79 for MT group), but not were not lower after the first session, without differences between the groups. AMMO was significantly higher after the first session (0.16 with 95% CI: 0.03 to 0.29 for DN group; 0.30 with 95% CI: 0.20 to 0.41 for MT group) and at the end of treatment in both groups (0.27 with 95% CI: 0.14 to 0.41 for DN group; 0.37 with 95% CI: 0.22 to 0.52 for MT group) compared with the baseline measurements. Finally, PPT results for the masseter and pterygoid muscles were significantly higher at the end of treatment in both groups (without statistically significant differences between groups), but not after the first session. The assessed therapies, DN and MT, are equally effective in improving pain, AMMO, cervical disability, and PPT in the muscles directly involved in the temporomandibular joint biomechanics of patients with myofascial TMDs.

Project description:IntroductionTemporomandibular disorder (TMD) is considered the main cause of orofacial pain of non-dental origin, and a public health problem. The symptomatology is muscular and/or articular pain, restriction of the mandibular range of motion, and changes in the mandibular movement pattern. Due to its complexity there are already treatments using various forms of therapy. Photobiomodulation using light sources, such as low-level laser or light emitting diodes (LED), with different wavelengths, in a single or combined form, allows one more therapeutic resource to be explored. The objective of this study is to evaluate the effects of photobiomodulation with the simultaneous use of red and infrared LEDs, on pain, range of mandibular movements, and on the electrical activity of masticatory muscles in individuals with TMD.MethodsA randomized, controlled, double-blind clinical trial is proposed, which will involve 33 individuals (n = 11 per group) of both sexes, ages 18 to 45 years in 3 groups: LED group; placebo group; and control group, submitted to 6 non-consecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders-RDC/TMD will be used to assess and determine the participants' TMD. The pain will be assessed using the Visual Analog Scale - VAS, the mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs-660 nm and 18 infrared LEDs-850 nm with power of 3.5 mW per LED, 4.45 mW/cm, radiant exposure of 5.35 J/cm, will be used for photobiomodulation. The irradiated area will be 14.13 cm, and energy of 75.6 J, in the TMJ region and in the bilateral masseter and temporal muscles. Participants from all groups will be reassessed after the first therapeutic intervention, and at the end of treatment.DiscussionWe expect the use of photobiomodulation with LEDs, infra and red, to reduce pain, improve temporomandibular joint function in patients with TMD, and thus improve the general conditions of the patient.

Project description:BackgroundTemporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactorial and there are several types of treatment, with the conservative types being indicated more often as they are less aggressive and reversible. The main aim of these treatments is to relieve symptoms, reduce of pain, and restore orofacial and cervical skull functions. Photobiomodulation therapy (PBMT), a noninvasive therapy, is an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects.MethodsThe aim of the proposed study is to verify whether PBMT is effective for use in palliative care of TMD and orofacial and cervical skull pain. A randomized, triple-blinded, placebo-controlled clinical trial is proposed. This study will involve 200 adult participants (over 18 years of age) who will be randomly divided into two groups (n = 100): Group 1, active treatment (PBMT); and Group 2, placebo. Participants will be subjected to three sessions of PBMT or placebo and will be evaluated using the research diagnostic criteria (RDC) for TMD. Pain level (measured by a visual analog scale (VAS)), mandibular movements (measured by ruler and caliper), quality of life (measured by the Oral Health Impact Profile (OHIP)-14), and quality of sleep (measured by the Epworth scale) will be recorded. This study is being conducted at the Special Laboratory of Lasers in Dentistry (LELO) of the School of Dentistry of the University of Sao Paulo (USP).DiscussionThis study will verify whether PBMT is effective in reducing TMD and orofacial and cervical skull pain. PBMT may be an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects, in addition to being a noninvasive technique.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-9b6mnj . Registered on 27 March 2018. Trial registry name: Laser de baixa potência no cuidado paliativo da disfunção temporomandibular e dor crânio orofacial e cervical. Ethics committee: #1774930 approved on 14 October 2016.

Project description:IntroductionGenitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM.ObjectiveThe goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region.MethodIn this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one.Trial registrationThis protocol is registered at ClinicalTrials.gov under the number NCT05557799.

Project description:To evaluate the effect of photobiomodulation therapy (PBMT) on painful temporomandibular disorders (TMD) patients in a randomized, double-blinded, placebo-controlled manner. Participants were divided into a masseter myalgia group (n = 88) and a temporomandibular joint (TMJ) arthralgia group (n = 87) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups randomly received PBMT or placebo treatment once a day for 7 consecutive days, one session. The PBMT was applied with a gallium-aluminum-arsenide (GaAlAs) laser (wavelength = 810 nm) at pre-determined points in the masseter muscle (6 J/cm2, 3 regions, 60 s) or TMJ region (6 J/cm2, 5 points, 30 s) according to their most painful site. Pain intensity was rated on a 0-10 numerical rating scale (NRS) and pressure pain thresholds (PPT) and mechanical sensitivity mapping were recorded before and after the treatment on day 1 and day 7. Jaw function was assessed by pain free jaw opening, maximum unassisted jaw opening, maximum assisted jaw opening, maximum protrusion and right and left excursion. Data were analyzed with a mixed model analysis of variance (ANOVA). Pain intensity in arthralgia patients decreased over time (P < 0.001) for both types of interventions, however, PBMT caused greater reduction in pain scores than placebo (P = 0.014). For myalgia patients, pain intensity decreased over time (P < 0.001) but without difference between interventions (P = 0.074). PPTs increased in both myalgia (P < 0.001) and TMJ arthralgia patients over time (P < 0.001) but without difference between interventions (P ≥ 0.614). Overall, PBMT was associated with marginally better improvements in range of motion compared to placebo in both myalgia and arthralgia patients. Pain intensity, sensory function and jaw movements improve after both PBMT and placebo treatments in myalgia and arthralgia patients indicating a substantial non-specific effect of PBMT.

Project description:BackgroundFibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin.Methods/designA randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay.DiscussionThis is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures.Trial registrationClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.

Dataset Information

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

Background

Methods

Discussion

Publications

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

Similar Datasets

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