Clinical trial NCT04116255: Effects of Occlusal Splint and Therapeutic Home Exercises
Official title: Effects of Occlusal Splint and Therapeutic Home Exercises on Neuropathic Pain and Oral Health-related Quality of Life in Temporomandibular Disorders: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Neuropathic Pain
Somatic Pain
Keywords: Temporomandibular joint disorders
exercise therapy
occlusal splint
neuropathic pain
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized prospective study
Primary purpose: TREATMENT

Brief summary: In this randomized controlled study, investigators planned to investigate the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction, determine their effects on other clinical data, and report long-term outcomes

Detailed description: The aim of the present study to compare the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction and report long-term outcomes.

One hundred and one patients with temporomandibular joint dysfunction were included in the study. The patients were randomly divided into two groups: The first group received a mandibular oral occlusal splint and the second group was given a home exercise program for the temporomandibular joint. The patients were evaluated based on their maximum mouth opening, visual analog scale, short-form McGill pain questionnaire, painDETECT, oral health-related quality of health and hospital anxiety and depression scale scores at the beginning of treatment and at the end of the first and sixth months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of temporomandibular joint disorders for more than one month
* Being aged 18 to 60 years

Exclusion Criteria:

* History of trauma to temporomandibular joint or face
* History of an inflammatory joint disease
* Chronic analgesic use lasting more than six months
* Previous treatment for temporomandibular joint disorders
* History of a major psychiatric, neurological or neuromuscular disease (Lambert-Eaton syndrome, orofacial or tardive dyskinesia, myasthenia gravis)
* Migraine diagnosis
* Chronic headache or neck pain
* Chronic pain syndrome
* Pregnancy
* Disc displacement with or without reduction

Primary outcomes:
measure: Pain-free maximum mouth opening
timeFrame: six months
measure: Visual analog scale
timeFrame: six months
measure: painDETECT
timeFrame: six months
measure: Oral health-related quality of health
timeFrame: six months
Secondary outcomes:
measure: Short-form McGill pain questionnaire
timeFrame: six months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
affiliation: Ankara Training and Research Hospital
name: Secil Vural
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University, faculty of dentistry
name: Cagil Vural
role: STUDY_DIRECTOR
affiliation: Ankara University, faculty of dentistry
name: Ali Ekemen
role: PRINCIPAL_INVESTIGATOR
References: