Clinical trial NCT05352438: Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction
Official title: Investigation of the Effectiveness of Manual Therapy and Splint Therapy in Patients With Myofascial Temporomandibular Dysfunction Combined With Bruxism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Myofascial Pain
Bruxism
Keywords: Temporomandibular Dysfunction
Bruxism
Manual Therapy
Splint
Lead sponsor: Turkoglu Dr. Kemal Beyazit State Hospital
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Pain severity at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change frim Baseline in Fatigue severity at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Sleep quality at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Jaw Function limitation at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Neck Disability at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Headache severity at 4 weeks
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change from Baseline in Head Posture at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Cervical Range of Motion at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks
timeFrame: Baseline, 4 weeks
measure: Change from Baseline in Trigger points at 4 weeks
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Türkoğlu Dr. Kemal Beyazıt State Hospital
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer
role: STUDY_DIRECTOR
References: