Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02880774 |
| Other study ID # |
Uninove_Reabilitação |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
February 2022 |
| Source |
University of Nove de Julho |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex
and multifactorial pathology, where functional and pathological changes commit
temporomandibuar articulation, masticatory muscles, and other associated structures. In the
light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment,
including physical therapy with the use of manual features, has been excelling. Objective:
The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on
the mandibular movement and lateralidades, through the three-dimensional kinematics in
subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and
functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment
sessions. Method: This is a clinical trial randomised, placebo-controlled and blind, designed
to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned ultrasound).
Individuals will be randomised controlled trials and allocated into two groups: Group A
(intervention) and Group B (placebo) and evaluated by the Research Diagnostic Criteria for
Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale of Pain
(END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional Scale and
Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will be the
primary outcome and will be quantified by three-dimensional kinematic analysis. The pain,
Functionality and quality of life will be the secondary outcomes. Initially the distribution
of data will be checked by the Shapiro-Wilk test. In comparisons between the groups, if the
data present normal distribution will be used a repeated measures ANOVA to two factors, being
these: Group (intervention and placebo) and treatment (pre and post-intervention), with
Bonferrone correction. If the data do not show normal distribution, a logarithmic function is
used to correct striping. As level of significance will be used p < 0.05.
Description:
Contextualization:Temporomandibular joint dysfunction (TMD) is defined as a group of
heterogeneous changes affect a temporomandibular joint (TMJ), affecting anatomical and
functional elements, is characterized as a complex and multifactorial disease. The most
common signs are joint noises and limitations on the extent of the mandibular movements,
associated or not to the articular disc displacement during a mandibular function and
predominant symptoms are pain pre-Auricular, on ATM and/or masticatory muscles. A study of an
urban brazilian population shows that 39.2% of evaluated feature at least one sign or symptom
of TMD.
Its development can be related to the traumatic acometimentos of the jaw or occlusal
interference or TMJ, malocclusion, changes in masticatory muscles, microtrauma caused by
parafunctional habits, rheumatic diseases, emotional stress, anxiety and postural
abnormalities, thus creating a major impact on quality of life and sleep of patients with
this disease.
When there is a breakdown between anatomical condyle and articular eminence, disk, drift to
occur for the most part, are characterized as previous joint disc displacement, with or
without reduction. In both cases, the disk is presented prior to the mandibular condyle with
mouth closed, and can resume his position, featuring a disc displacement with reduction
(DDCR), having as main feature the snap during an opening. The disc may get introduced before
the condyle during the entire opening movement, made a previous offset oral disc without
reduction (DDSR), characterized by the presence of clicks, including, in the most serious
cases, cause a limitation of motion and functional changes of the mandible, the adaptation of
the retrodiscais tissue.
In the light of the whole complexity of the DTM it is necessary the involvement of a
multidisciplinary team, including physiotherapy, with the use of manual features, have been
highlighting. Manual therapy has been shown to be an important method for pain reduction,
disabled and local ischemia, promoting the breakup of fibrous adhesions, improving
extensibility of contractile structures, increasing range of motion. Notes that the use of
Manual therapy favours the transmission of afferent information for the mecanoceptores
stimulating a proprioception and a production of synovial fluid. Studies that have applied
manual therapy, electing as mandibular mobilization technique in subjects with TMD, pain
reduction and improvement of mandibular range. FELÍCIO et al. (2008), observed increase in
WMD and pain reduction in patients treated with Orofacial Miofuncional Therapy in association
with techniques such as massage therapy and a joint mobilization.
Knowledge of the movement of the jaw is important for a better understanding of the normal
function of the temporomandibular joint (TMJ) and for the study of etiology, diagnosis and
subsequent treatment of temporomandibular disorders. The mandibular movement also exerts
influence on the joint development of the masticatory system. Therefore, knowing the
three-dimensional movement of the jaw (3D) in relation to jaw is essential for clinical
applications. A literature provides information on a range of motion measured by the distance
between incisal edges of teeth like upper and lower incisors through digital central
pachymetry and the average value of opening mouth of UM adult is approximately 50 mm. In
patients with TMD buccal opening average is 32 mm and 44 mm to maximum opening without pain.
In this way, pick up tools can exploit better a movement evaluation, will contribute without
therapeutic success. The kinematics has been increasingly diffused in different areas of
knowledge, as in gait analysis of adolescents, children, biomechanical related changes of the
feet and Musculoskeletal changes related to patellofemoral syndrome, being useful also in the
qualitative evaluation of the ATM graduates movements.
So, based on previous studies of our research group (AMARAL et al. 2013) (EL HAGE et al.
2013) the hypothesis of this study, on the basis of physiological changes promoted by
mandibular nonspecific mobilization is a change to occur without mandibular movement and
consequent reduction of signs and symptoms in patients with temporomandibular joint
dysfunction.
Justification: Currently, the literature has been investigating various methods of evaluation
and the possibilities of treatment of TMD. These findings highlight the current scientific
clinical needs of health professionals, according to be a multifactorial origin dysfunction,
with complex diagnostic and pathological mechanism which may involve several structures of
the Stomatognathic system, so the more show themselves effective therapeutic resources
scientifically, better treatment strategies for DTM.
Thus, this study proposes a treatment with physical therapy manual therapy technique known as
Mandibular Nonspecific Mobilization, followed by the analysis of jaw movements in functional
activities, carried out pre-and post-intervention physiotherapist. Their results can be of
great significance and clinical trial for understanding the mandibular movement especially
when the individual presents any signs and/or symptoms of TMD and there is need to perform
some type of treatment and subsequent evaluation of mandibular movement. In spite of the work
found in the literature with analysis of mandibular movements in patients with TMD no studies
that evaluate and compare these findings after physiotherapeutic treatment, stimulating us to
pick up as a manual therapy intervention can interfere with movement, through kinematic
analysis.
As a result, and for reasons mentioned above, the investigators need to continue and deepen
the various studies related to the treatment and evaluation of DTM (FAPESP 2013
processes/23955-6; 13/3-18354; 12/16093-5; 12/07759-0; 11/13397-0; 11/12537-3; 11/04748-4;
10/17801-8; 08/05980-5; 08/05888-1). It is known that 39.2% of the brazilian population,
presents at least a sign or symptom of DTM second epidemiology study. Therefore, showing this
as a national reference, and knowing that the TMD is multifactorial, the more therapeutic
resources may be effective scientifically, better treatment strategies for TMD and can
contribute to the public health by helping the reduction of rates of incidence, in research
and in practice.
Research hypothesis: the mandibular nonspecific mobilization changes the mandibular movement
and increases joint mobility in patients with TMD pre, immediately after and 30 days after 12
treatment sessions.
Null hypothesis: the mandibular nonspecific mobilization does not change the mandibular
movement and does not increase joint mobility in patients with TMD pre, immediately after and
30 days after 12 treatment sessions.
General objective: The objective of this study is to evaluate the influence of mandibular
nonspecific mobilization on the mandibular movement and lateralidades, in individuals with
diagnosis of TMD pre, immediately after and 30 days after 12 treatment sessions.
Specific objectives: to analyse the intensity of the pain by means of numerical scale of Pain
(END), immediately after and 30 days after 12 treatment sessions, analyze the quality of life
through the WHOQOL-BREF questionnaire of individuals with DTM pre, immediately after and 30
days after 12 treatment sessions, analyze the functionality through the Functional Range
Specifies the Patient pre, immediately after and 30 days after 12 treatment sessions.
Methodology:
It is a randomised clinical trial, placebo, controlled and blind, designed to study the
effects of Mandibular Mobilization technique x Nonspecific Placebo (detuned Ultrasound).
Individuals will be allocated into two groups by a randomization process in blocks (will be
two blocks of 24 envelopes in total), using opaque and sealed envelopes containing: Group A =
n12 (intervention) and Group B = n12 (placebo).
The evaluations will be carried out using: Research Diagnosis Criteria for Temporomandibular
joint Disorders (RDC/TMD), END, WHOQOL-BREF, Functional Range Specifies the Patient, Central
pachymetry and Kinematic Analysis.
The study will be divided into four phases:
Pre-intervention phase: individuals shall be recruited in accordance with the criteria for
inclusion and assessed by the RDC/TMD for diagnosis of TMD. The evaluation of quality of life
will be held through the WHOQOL-BREF, the intensity of the pain will be mesurada by the END,
the functionality will be evaluated through Functional range Specifies the patient and
mandibular movements will be captured and analyzed by Kinematic motion Analysis.
Intervention phase: individuals are randomised controlled trials in 2 groups: Group A
(intervention): Mandibular Nonspecific and Mobilization Group B (placebo): using an
ultrasound device detuned. The treatment will take place three times a week for 12 sessions
of approximately 30 minutes each. Before and at the end of each session, the individuals will
be evaluated by the END and will be held the Central pachymetry to measure the opening and
lateralidades.
Post-intervention phase: in this phase will be carried out the same reviews of
pre-intervention phase, which occurs immediately after the intervention phase.
Follow-up phase: one month after the last session will be held again the same pre and pos
phase ratings.
Blinding: Four physiotherapists and a dentist will be part of the Protocol. One will be
responsible for the evaluations. The second physical therapist will be responsible for the
intervention phase, which is blind to the assessments and allocation of participants in the
groups. Other physical therapist will be responsible for the performance of the kinematic
analysis (a dentist will monitor the collections and will carry out the placement and removal
of the brackets in the participants) and a quarter will do the processing and analysis of the
data collected. The randomization and concealment of allocation will be carried out by an
external developer, non-participant of the research, that will organize in opaque envelopes
the individual patients and their interventions (Group A) and placebo (Group B) previously
allocated. With this process, participants will have the same probability of being in one of
the two treatment groups. The blinding of the evaluator and the patients will be held until
the end of the research and data tabulation.
SAMPLE CALCULATION: The sample size was set from a pilot study with 8 individuals with DTM,
with an average age of 28.6 ± 3.1 years and average height of 168.2 ± 10.8 cm. The average
value of the oral opening movement pre (43.31 ± 5.69 mm) and post (50.83 ± 4.97) 12 sessions
of mandibular nonspecific mobilization were used for this estimate. For the calculation were
considered the values α = 0.05 (5% chance of type I error) and 1-β = 0.95 (% of the sample).
The estimated number was of 9 individuals. Considering the possibility of a sampling of 20%
loss were considered for this study 11 individuals. However, to increase the statistical
power, 15 individuals per group will be used. The calculation was carried out by means of
software G * Power.
STATISTICAL ANALYSIS: The mandibular movement is the primary outcome and will be for the
three-dimensional kinematics analysis quantified. A pain, functionality and quality of life
will be the secondary outcomes. Initially a distribution of data will be checked by the
Shapiro-Wilk test. In comparisons between the groups, if the data present normal distribution
is a repeated measures ANOVA notes of two factors, being these: Group (experimental and
control) and treatment (pre and post-intervention), with Bonferrone correction. If the data
do not show normal distribution, a logarithmic function is used to correct striping. As level
of significance will be used p < 0.05. All comparisons and statistical analyses are performed
using the SPSS program, version 20.0 (Chicago, IL, USA).
