Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction

NCT ID: NCT05352438

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2020-07-27

Brief Summary

The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.

Detailed Description

A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.

The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.

Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).

After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.

Conditions

Temporomandibular Disorder; Myofascial Pain; Bruxism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy Group

Manual Therapy combined with education and home exercises

Group Type: EXPERIMENTAL

Manual Therapy Group

Intervention Type: OTHER

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Manual Therapy group received a manual therapy program applied as 2 sessions of 45 mins each week for 4 weeks (total 8 sessions) by an investigator. Soft tissue and joint mobilizations were applied to the TMJ and surrounding structures and to cervical segments, trigger point treatment was applied to trigger points, and myofascial loosening was performed. Patients were instructed to perform the exercises learned in the home exercise program in 3 sets of 10 repetitions every day.

Splint Therapy Group

Splint Therapy combined with education and home exercises

Group Type: EXPERIMENTAL

Splint Therapy Group

Intervention Type: OTHER

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Splint Therapy group was given a static occlusal splint, and adjustments were made as necessary. All the patients in this group were instructed to use the splint when sleeping for a period of one month.

Interventions

Manual Therapy Group

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Manual Therapy group received a manual therapy program applied as 2 sessions of 45 mins each week for 4 weeks (total 8 sessions) by an investigator. Soft tissue and joint mobilizations were applied to the TMJ and surrounding structures and to cervical segments, trigger point treatment was applied to trigger points, and myofascial loosening was performed. Patients were instructed to perform the exercises learned in the home exercise program in 3 sets of 10 repetitions every day.

Intervention Type: OTHER

Splint Therapy Group

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Splint Therapy group was given a static occlusal splint, and adjustments were made as necessary. All the patients in this group were instructed to use the splint when sleeping for a period of one month.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages between 18 and 50 years old,
• Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
• Having pain severity ≥3 according to the Visual analogue scale (VAS),
• Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.

Exclusion Criteria

• Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
• a history of surgery associated with cervical and/or TMJ problems,
• a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
• a history of facial paralysis, a diagnosed psychiatric disease,
• if they were undergoing orthodontic treatment,
• had received physiotherapy within the last 3 months,
• or could not be co-operative.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Turkoglu Dr. Kemal Beyazit State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Süreyya DAMAR ÖRENLER

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysenur Tuncer

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

Türkoğlu Dr. Kemal Beyazıt State Hospital

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019-67

Identifier Type: -

Identifier Source: org_study_id