NCT04116255

Effects of Occlusal Splint and Therapeutic Home Exercises

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Ankara Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Quality of Life
• Neuropathic Pain
• Somatic Pain

Interventions

Type	Name	Description
OTHER	Mandibular oral occlusal splint	The panoramic open-mouth and close-mouth radiographs of the first group(splint group) were taken, and intraoral and extraoral examinations were performed by an experienced dentist that also examined the radiographs. The upper jaw of the patients was measured with an alginate impression material, to obtain a hard plaster model. Then, using these models, a vacuum plate machine made a customized mandibular oral occlusal splint suitable for each patient's teeth. The suitability of the splints was checked and confirmed by the dentist on the first and seventh days of use. The patients were asked to use these splints at night (for at least six hours) throughout the study.
OTHER	Temporomandibular joint Exercises	This program was created by combining patient training and a home exercise program. The exercise program consisted of slow passive and active mouth opening and closing exercises, isometric masseter exercises, mouth stretching exercises, and resistant mouth opening and closing exercises. Each exercise set was administered twice a day, and each movement was undertaken for 10 seconds and repeated 15 times. The training was given by an experienced physical medicine and rehabilitation expert over approximately 45 minutes. The exercise program was demonstrated for the patients in front of a mirror, and each exercise was performed by a set of patients under the supervision of a doctor. A training document including the written exercise program was to the patients in the exercises group.

Timeline

• Start date: 2019-10-05
• Primary completion: 2020-04-05
• Completion: 2020-04-20
• First posted: 2019-10-04
• Last updated: 2020-07-28

Locations

1 site across 1 country: Turkey (Türkiye)