Effects of Occlusal Splint and Therapeutic Home Exercises

NCT04116255 | Completed

• 1 other identifier: 14719
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Quality of Life; Neuropathic Pain; Somatic Pain

Keywords

Temporomandibular joint disorders; exercise therapy; occlusal splint; neuropathic pain

Outcome Measures

Primary Outcomes (4)

• Pain-free maximum mouth opening

  This was measured in millimeters at the baseline and at each follow-up visit. The patients were asked to open their mouths as much as they could without having pain. Central incisors were measured in millimeters three times consecutively, and the highest measurement was recorded

  six months

• Visual analog scale

  The visual analogue scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Ranges from 0 to 10 points, where the former indicates 'no pain' and the latter 'worst pain ever'. The patients were asked to mark the point that best represented the level of pain they experienced.

  six months

• painDETECT

  This scale is to evaluate the presence of neuropathic pain. PainDETECT incorporated an easy to use, patient- base questionnaire with nine items that do not require a clinical examination. There are seven weighted sensory descriptor items (''never'' to ''very strongly'') and two items relating to the spatial and temporal characteristics of the individual pain pattern. minimum score is 0 points and maximum score is 30 points. Patients with a total score of 12 or less are considered to have no neuropathic pain component. If the total score is between 13 and 18, it is assumed that a neuropathic component may be present although the result is not certain, and scores of 19 and above indicate the presence of a neuropathic pain component.

  six months

• Oral health-related quality of health

  This scale measures how an individual's oral health affects their quality of life and overall health, and how that they personally perceive this situation. A scoring known as oral health impact profile-14 is used, in which functional disability, physical pain, psychological disability, physical, psychological and social disability, and handicap measures are evaluated using two questions each. As the total score increases, the severity of the problem increases and the quality of life decreases.The minimum and maximum scores of this assessment tool is 0 and 56, respectively.

  six months

Secondary Outcomes (1)

• Short-form McGill pain questionnaire

  six months

Study Arms (2)

exercises group

EXPERIMENTAL

exercises group apply regular therapeutic home exercises programme

Other: Temporomandibular joint Exercises

splint group

EXPERIMENTAL

splint group use mandibular oral occlusal splint

Other: Mandibular oral occlusal splint

Interventions

Mandibular oral occlusal splint 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.

splint group

Temporomandibular joint Exercises 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.

exercises group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuralgia; Nociceptive Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Secil Vural

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Cagil Vural

  Ankara University, faculty of dentistry

  STUDY DIRECTOR

• Ali Ekemen

  Ankara University, faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Physical Medicine and Rehabilitation,

Model Details: a randomized prospective study

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 4, 2019
• Study Start: October 5, 2019
• Primary Completion: April 5, 2020
• Study Completion: April 20, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)