Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction
- Conditions
- BruxismTemporomandibular DisorderMyofascial Pain
- Interventions
- Other: Manual Therapy GroupOther: Splint Therapy Group
- Registration Number
- NCT05352438
- Lead Sponsor
- Turkoglu Dr. Kemal Beyazit State Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Therapy Group Manual Therapy Group Manual Therapy combined with education and home exercises Splint Therapy Group Splint Therapy Group Splint Therapy combined with education and home exercises
- Primary Outcome Measures
Name Time Method Change from Baseline in Pain severity at 4 weeks Baseline, 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.
Change from Baseline in Jaw Function limitation at 4 weeks Baseline, 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).
Change from Baseline in Headache severity at 4 weeks Baseline, 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.
Change frim Baseline in Fatigue severity at 4 weeks Baseline, 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.
Change from Baseline in Sleep quality at 4 weeks Baseline, 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.
Change from Baseline in Neck Disability at 4 weeks Baseline, 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).
Change from Baseline in Patient Satisfaction questionnaire at 4 weeks. Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Head Posture at 4 weeks Baseline, 4 weeks Head posture is defined as the craniovertebral angle. It is the angle formed by the intersection of a horizontal line along the spinous process of C7 and the line drawn towards the ear tragus. A craniovertebral angle of \<48-50° is accepted as an anterior tilt of the head.
Change from Baseline in Trigger points at 4 weeks Baseline, 4 weeks While the participants were in the supine position the masseter, temporalis, pyterigoideus lateralis, pyterigoideus medialis, and digastric muscles were evaluated. In the sitting position, the sternoclavicular, suboccipital, and upper trapezius muscles were palpated, and the trigger points in these muscles and their number were evaluated.
Change from Baseline in Cervical Range of Motion at 4 weeks Baseline, 4 weeks A goniometer was used to measure the cervical region's range of motion (ROM). Cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees were measured and recorded.
Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks Baseline, 4 weeks For maximal mouth opening, the distance between the upper and lower incisors was measured and recorded. For protrusion, the distance between the lower and upper incisors was measured horizontally by asking the patient to bring the lower jaw forward as far as possible while the posterior teeth were in contact with each other. For right and left lateral shifts, the distance between the upper and lower incisors was measured by asking the patient to slide it to the right and left separately as much as possible.
Trial Locations
- Locations (1)
Türkoğlu Dr. Kemal Beyazıt State Hospital
🇹🇷Kahramanmaraş, Turkey