Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction

NCT05352438 | Completed

• 1 other identifier: 2019-67
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder; Myofascial Pain; Bruxism

Keywords

Temporomandibular Dysfunction; Bruxism; Manual Therapy; Splint

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in Pain severity at 4 weeks

  Pain severity was measured with a Visual Analogue Scale (VAS), marked from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. The patients were instructed to mark the scale corresponding to the severity of pain felt.

  Baseline, 4 weeks

• Change frim Baseline in Fatigue severity at 4 weeks

  Fatigue level was measured with the Fatigue Severity Scale, where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.

  Baseline, 4 weeks

• Change from Baseline in Sleep quality at 4 weeks

  The sleep quality of patients was analyzed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI includes 24 items related to both daytime and nocturnal sleep. The responses were scored from 0-3, as 7 subscores to give a global score of total points in the range of 0-21. A score of ≥5 indicated poor sleep quality.

  Baseline, 4 weeks

• Change from Baseline in Jaw Function limitation at 4 weeks

  Jaw function limitation was measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients asked for from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).

  Baseline, 4 weeks

• Change from Baseline in Neck Disability at 4 weeks

  Neck Disability Index, consists of 10 items. Individuals included in the study were asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).

  Baseline, 4 weeks

• Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.

  The Patient Satisfaction questionnaire was used to assess the patient's satisfaction with the treatment received. The patient satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.

  Baseline, 4 weeks

• Change from Baseline in Headache severity at 4 weeks

  The Headache Impact Test-6 (HIT-6) was used to assess the headache. The 6-item scale evaluates the frequency, the degree of restriction to daily life and social life, and changes in the mood. The total score of 50-59 reflects the important impact, and scores ≥60 indicate severe impact.

  Baseline, 4 weeks

Secondary Outcomes (4)

• Change from Baseline in Head Posture at 4 weeks

  Baseline, 4 weeks

• Change from Baseline in Cervical Range of Motion at 4 weeks

  Baseline, 4 weeks

• Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks

  Baseline, 4 weeks

• Change from Baseline in Trigger points at 4 weeks

  Baseline, 4 weeks

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

Manual Therapy combined with education and home exercises

Other: Manual Therapy Group

Splint Therapy Group

EXPERIMENTAL

Splint Therapy combined with education and home exercises

Other: Splint Therapy Group

Interventions

Manual Therapy Group 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.

Manual Therapy Group

Splint Therapy Group 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.

Splint Therapy Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turkoglu Dr. Kemal Beyazit State Hospital: lead

Study Sites (1)

Türkoğlu Dr. Kemal Beyazıt State Hospital

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior

Study Officials

• Aysenur Tuncer

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: January 21, 2019
• Primary Completion: February 28, 2020
• Study Completion: July 27, 2020
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

TU (1)