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Effects of Occlusal Splint and Therapeutic Home Exercises

Primary Purpose

Quality of Life, Neuropathic Pain, Somatic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandibular oral occlusal splint
Temporomandibular joint Exercises
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Temporomandibular joint disorders, exercise therapy, occlusal splint, neuropathic pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

exercises group

splint group

Arm Description

exercises group apply regular therapeutic home exercises programme

splint group use mandibular oral occlusal splint

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Short-form McGill pain questionnaire
This is a multidimensional scale containing items that investigate the sensory and perceptual dimension of pain and examines the relationship between pain and anxiety, as well as pain intensity over time. The questionnaire is completed by patients.The main component of the short form McGill pain questionnaire consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1= mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. From this assessment scale, patients can score a minimum of 0 and a maximum of 112.

Full Information

First Posted
September 30, 2019
Last Updated
July 25, 2020
Sponsor
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04116255
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 5, 2019 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Neuropathic Pain, Somatic Pain
Keywords
Temporomandibular joint disorders, exercise therapy, occlusal splint, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomized prospective study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercises group
Arm Type
Experimental
Arm Description
exercises group apply regular therapeutic home exercises programme
Arm Title
splint group
Arm Type
Experimental
Arm Description
splint group use mandibular oral occlusal splint
Intervention Type
Other
Intervention Name(s)
Mandibular oral occlusal splint
Intervention Description
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
Intervention Name(s)
Temporomandibular joint Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain-free maximum mouth opening
Description
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
Time Frame
six months
Title
Visual analog scale
Description
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.
Time Frame
six months
Title
painDETECT
Description
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.
Time Frame
six months
Title
Oral health-related quality of health
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Short-form McGill pain questionnaire
Description
This is a multidimensional scale containing items that investigate the sensory and perceptual dimension of pain and examines the relationship between pain and anxiety, as well as pain intensity over time. The questionnaire is completed by patients.The main component of the short form McGill pain questionnaire consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1= mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. From this assessment scale, patients can score a minimum of 0 and a maximum of 112.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Secil Vural
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cagil Vural
Organizational Affiliation
Ankara University, faculty of dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Ekemen
Organizational Affiliation
Ankara University, faculty of dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Occlusal Splint and Therapeutic Home Exercises

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