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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263053
Other study ID # UFCeara
Secondary ID
Status Completed
Phase N/A
First received September 26, 2014
Last updated September 5, 2016
Start date January 2014
Est. completion date December 2015

Study information

Verified date September 2016
Source Universidade Federal do Ceara
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is composed of the mandibular condyle is positioned within the glenoid fossa of the temporal bone, and the articular disk that separates these two bones. The normal biomechanics of the TMJ is the concave / convex relationship between the condyles and the articular disc. The movements of the TMJ joint are: mandibular depression and elevation (opening and closing of the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a musculoskeletal disorder of the masticatory system that affects over 25% of the population. Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain, reduce inflammation and restore normal motor functions. The physical therapy interventions taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall objective is to assess the immediate effects of previous mobilization versus flow amplitude of mandibular depression in patients with temporomandibular dysfunction. The type of study will be a randomized study of two parallel groups balanced distribution (1: 1) and double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to participate in the study due to symptoms of TMD. Data, anthropometry, application of Research Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist responsible for the assessment before and after the interventions will be blind with respect to the distribution of the treatment groups. The patient will also be blind, because you will not know whether or caudal anterior mobilization was performed. Randomization codes are generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by a researcher not involved in the data collection. These codes will be placed in sealed, opaque envelopes being numbered consecutively, which will ensure the covert allocation of study participants. Our data are considered confidential as joint property of the parties involved.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Individuals have not received the last 3 months treatment for TMD, who are not taking anti-inflammatory and / or analgesic for at least two weeks, you are not in the period of postoperative head and / or neck and to accept the participation in the study and signed the Instrument of Consent

Exclusion Criteria:

- Subjects with no teeth, history of metabolic diseases (such as hyper / hypothyroidism), neurological disorders, history of cancer in the last five years, active inflammatory arthritis, fractures, dislocations of the jaw or neck.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
POSTERIOR MOBILIZATION
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.
CAUDAL MOBILIZATION
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.

Locations

Country Name City State
Brazil Federal University of Ceara Fortaleza Ceará

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mandibular range of motion The caliper is a measuring instrument that inform the millimetric values of mandibular depression, as measured the distance between the edges of the incisors of the maxilla and mandible. Three measurements of the active mouth opening will be held, where the individual experiencing pain, the measurement will be the beginning of it, if he does not feel pain, be gauged from the maximum amplitude of movement. Soon after the arithmetic mean of the measurements will be made. Five minutes after mobilization Yes
Secondary Pain Intensity Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain) Five minutes after mobilization Yes
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