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Oral splint and counselling for the treatment of chronic facial pain

The efficacy of occlusal stabilization appliance associated to counselling in the management of myofascial pain chronic and in the improvement of the quality of life of patients with temporomandibular disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-795k8m
Enrollment
Unknown
Registered
2012-03-31
Start date
2012-03-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular disorder, stress psychological

Interventions

Study Group Intervention The reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist,
device
behavioural
other
F02.784.176

Sponsors

Universidade Federal de Juiz de Fora
Lead Sponsor
Patrícia Rocha Coelho
Collaborator
Josemar Parreira Guimarães
Collaborator
Thais Vidal Soares
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: All subjects participated in this study volunteers by signing the consent form. Inclusion criteria are as follows: female subjects; aged 20 to 55 years; irrespective of race, social status or religion; presence of pain intensity of at least moderate (at least 4.0 on VAS), shown in the first clinical assessment; diagnosis of myofascial pain persisting for a minimum period of six months.

Exclusion criteria

Exclusion criteria: history of psychiatric disorders or treatment for neurological or psychological disorders; volunteers with severe intellectual or physical disability that would hinder the collection of data; history of systemic diseases that generate joint symptoms, muscle or rheumatologic, such as rheumatoid arthritis and fibromyalgia; pain attributed to a well-defined local cause, such as pulpitis, trigeminal neuralgia and cancer pain; attributable to migraine pain or infection; report of any previous treatment for TMD; treatment with drugs affecting the central nervous system (muscle relaxants, anticonvulsants, opioids, and antidepressants) and treatment with analgesics and anti-inflammatory drugs, with or without prescription, concomitant therapies to be instituted in this research; report of facial trauma as a possible etiology of TMD; subject denture wearers an upper or lower; volunteers aged under 20 or over 55 years; male individuals.

Design outcomes

Primary

MeasureTime frame
Evaluation of physical symptoms before intervention and after 1, 2 and 3 months of intervention. The measurement of spontaneous orofacial pain intensity is obtained by means of Visual Analogue Scale (VAS). Evaluated at all times, will be obtained the average of pain intensity experienced by each group. The evolution of physical symptoms reported in each group will verify the effectiveness of interventions instituted in each group.;Evaluation of psycho-emotional aspects related to the TMD through the Diagnostic Criteria for Research of temporomandibular disorders (RDC / TMD, Axis II). To assess the impact of psycho TMD, we investigate measures of depression and nonspecific physical symptoms accompanied by pain (somatization). This measurement will be obtained before the intervention (T0) and at the end of the treatment period (T4). Calculation of the scores will be made by the instrument Symptom Check List (SCL-90R), which integrates the protocol score of RDC / TMD. From the comparison of levels of depression and somatization in the two periods may be identified changes in these symptoms, starting from the null hypothesis that there would be no changes in psychosocial symptoms of depression and somatization resulting from the prescribed therapies.;Assessment of Quality of Life related to TMD, which will be investigated before and after institution of therapy in each group. The comparison of scores in the two periods indicate a possible change in the index of quality of life. The instrument used for this will be the profile of the Oral Health Impact (OHIP-14).

Secondary

MeasureTime frame
Evaluation of physical symptoms return every biweekly of patients, which will verify oscillations of physical symptoms that would not be featured in the principal moments of estudo.A measuring the intensity of spontaneous orofacial pain is obtained by means of Visual Analogue Scale (VAS).

Countries

Brazil

Contacts

Public ContactPatrícia Coelho

Universidade Federal de Juiz de Fora

patriciacoelho.odonto@gmail.com(32) 99321100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)