Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

Official title:

Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726060
• Other study ID #: 47/2018/SPER/AUSLBO
• Status: Completed
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.

They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).

The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale

• HADS questionnaire).

Description:

Randomized controlled clinical trial with randomization according to a multi-phase design.

Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.

Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.

Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.

The 2 therapeutic protocols are:

• gnathological therapy (splint) associated with education and physiotherapy (test group);

• gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.

The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).

Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.

Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.

Both types of treatment will be performed by a single operator respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;

• patients older than 18 years;

• good knowledge of Italian language;

• patients who have signed informed consent

Exclusion Criteria:

• edentulism which makes it impossible to apply gnathological bite;

• patients with psychiatric problems;

• patients included in other experimental protocols;

• patients already undergoing surgical and / or radial therapy of the cervical and facial areas;

• other temporomandibular disorders without a myogenic component;

• treatment of the cervical and TMJ district in the previous 3 months;

• history of drug abuse.

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• control group
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
• test group
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy

Locations

Country	Name	City	State
Italy	University of Bologna	Bologna	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Pillastrini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain	The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing	Change from initial VAS at 3 and 6 months from the beginning of the treatment
Secondary	ROM (range of motion)	The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups.; It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite.; It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)	The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment