Effects of Occlusal Splint and Therapeutic Home Exercises

NCT ID: NCT04116255

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-05
• Study Completion Date: 2020-04-20

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.

Conditions

Quality of Life; Neuropathic Pain; Somatic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exercises group

exercises group apply regular therapeutic home exercises programme

Group Type: EXPERIMENTAL

Temporomandibular joint Exercises

Intervention Type: OTHER

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.

splint group

splint group use mandibular oral occlusal splint

Group Type: EXPERIMENTAL

Mandibular oral occlusal splint

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seçil Vural

Instructor of Physical Medicine and Rehabilitation,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Secil Vural

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Research Hospital

Cagil Vural

Role: STUDY_DIRECTOR

Ankara University, faculty of dentistry

Ali Ekemen

Role: PRINCIPAL_INVESTIGATOR

Ankara University, faculty of dentistry

Locations

Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

14719

Identifier Type: -

Identifier Source: org_study_id