Oral splint and counselling for the treatment of chronic facial pain

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-795k8m
• Date of registration: 31/03/2012
• Primary sponsor: Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil
• Public title: Oral splint and counselling for the treatment of chronic facial pain
• Scientific title: 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
• Date of first enrolment: 05/03/2012
• Target sample size: 40
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-795k8m/
• Study design: Randomized double-blind controlled study,two treatment arms

Countries of recruitment

Brazil

Contacts

• Name: Patrícia Coelho
• Affiliation: Universidade Federal de Juiz de Fora

• Name: Patrícia Coelho
• Affiliation: Universidade Federal de Juiz de Fora

Key inclusion & exclusion 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: 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.

Age minimum: 20Y
Age maximum: 55Y
Gender: F

Health Condition(s) or Problem(s) studied

Temporomandibular disorder, stress psychological
C05.500.607.221.897
F01.145.126.990
F01.145.126.350
I01.800

Intervention(s)

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, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.

Control Group Intervention
The non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the plate.

In this study, all patients (study and control group) will undergo a counseling approach / self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the

Primary Outcome(s)

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).

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.

Secondary Outcome(s)

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).

Secondary ID(s)

0183.0.180.000-11

199/2011

Source(s) of Monetary Support

Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil

Secondary Sponsor(s)

Josemar Parreira Guimarães - Juiz de Fora, MG, Brazil

Patrícia Rocha Coelho - Juiz de Fora, MG, Brazil

Thais Vidal Soares - Juiz de Fora, MG, Brazil