Quality of LifeNCT04116255
Effects of Occlusal Splint and Therapeutic Home Exercises
A study testing Mandibular oral occlusal splint and Temporomandibular joint Exercises in people with Quality of Life and Neuropathic Pain, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Quality of Life, Neuropathic Pain, Somatic Pain
- What is being tested?
- Mandibular oral occlusal splint and Temporomandibular joint Exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2019to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of temporomandibular joint disorders for more than one month
- Being aged 18 to 60 years
Who cannot join
- 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
Show all 10Show fewer
- Chronic headache or neck pain
- Chronic pain syndrome
- Pregnancy
- Disc displacement with or without reduction
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Mandibular oral occlusal splint, Temporomandibular joint Exercises
- Keywords
- Temporomandibular joint disorders, exercise therapy, occlusal splint, neuropathic pain
- Medical subject headings
- Neuralgia, Nociceptive Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular oral occlusal splintOther
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.
Temporomandibular joint ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| exercises group | Experimental | exercises group apply regular therapeutic home exercises programme Receives: Other: Temporomandibular joint Exercises |
| splint group | Experimental | splint group use mandibular oral occlusal splint Receives: Other: Mandibular oral occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six months
Secondary outcomes (1)
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start5 Oct 2019
- Primary completion5 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized prospective study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Vural, Ankara Training and Research Hospital
- Investigators
- Secil Vural, Principal investigator, Ankara Training and Research HospitalCagil Vural, Study director, Ankara University, faculty of dentistryAli Ekemen, Principal investigator, Ankara University, faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116255
- Sponsor's protocol ID
- 14719
- Status last verified
- Jul 2020
- First submitted
- 30 Sep 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04116255
- Acronym / sponsor ID
- 14719
- Conditions
- Quality of Life, Neuropathic Pain, Somatic Pain
- Keywords
- Temporomandibular joint disorders, exercise therapy, occlusal splint, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| exercises group | Experimental | Other: Temporomandibular joint Exercisesexercises group apply regular therapeutic home exercises programme |
| splint group | Experimental | Other: Mandibular oral occlusal splintsplint group use mandibular oral occlusal splint |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of temporomandibular joint disorders for more than one month
- Being aged 18 to 60 years
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular oral occlusal splintThe 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 | splint group |
| Temporomandibular joint ExercisesThis 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. | Other | exercises group |
Primary outcome
Pain-free maximum mouth opening
Time frame: six months
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
Time frame: six months
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
Time frame: six months
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
Time frame: six months
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.
1 secondary outcome
Short-form McGill pain questionnaire
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secil Vural principal investigator
Ankara Training and Research Hospital
Cagil Vural study director
Ankara University, faculty of dentistry
Ali Ekemen principal investigator
Ankara University, faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular oral occlusal splint and Temporomandibular joint Exercises in people with Quality of Life and Neuropathic Pain, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-free maximum mouth opening (time frame: six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.