Myalgia of Mastication MuscleNCT04588636
Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain
A study testing behavioral and self-care therapy, rigid occlusal splint (ROS) and soft occlusal splint (SOS) in people with Myalgia of Mastication Muscle, run by Universidad Nacional Andres Bello at 1 site in Chile.
Trial summary
The objective of this study was to compare the clinical effectiveness of personalized thermoformed occlusal splints together with behavioral and self-care therapy in the management of myalgia of the masticatory muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myalgia of Mastication Muscle
- What is being tested?
- behavioral and self-care therapy, rigid occlusal splint (ROS) and soft occlusal splint (SOS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChile
- Study dates
- 16 Oct 2017to 16 Jan 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 40 years
- Presence of myalgia of the masticatory muscles with or without limitation of the mouth opening according to DC / TMD diagnostic criteria
Who cannot join
- Painful joint TMD
- History of treatment for TMD
- Recent history of facial or cervical trauma
- Current orthodontic treatment
- Tooth mobility secondary to periodontal disease
- Subjects with loss of more than two teeth other than third molars and / or premolars due to orthodontic indication
- Subjects with systemic musculoskeletal diseases or who are under analgesic treatment
- Subjects with a diagnosed intellectual disability who cannot express their will to participate in scientific research as established by law 20.584 of Chile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain: a Controlled Clinical Trial.
The objective of this study was to compare the clinical effectiveness of personalized thermoformed occlusal splints together with behavioral and self-care therapy in the management of myalgia of the masticatory muscles. A controlled clinical trial was carried out with a total of 46 subjects diagnosed with myalgia according to the diagnostic criteria for temporomandibular disorders (DC / TMD). All subjects were treated with behavioral and self-care therapy (BST) at the beginning of the study, and were then randomized into 4 groups: behavioral and self-care control group; rigid occlusal splint group; soft occlusal splint group and non-occlusive splint group. Follow-ups were carried out at 2, 6 and 10 weeks, where it was evaluated: pain in the masticatory muscles, mandibular range of motion, mandibular functional limitation and occlusal discomfort.
Read the detailed description
Materials and method This randomized controlled clinical trial was conducted between October 2017 and January 2018 at the Dental Clinic of the Andrés Bello University (Viña del Mar, Chile). The study subjects were recruited from the universe of patients seeking treatment for jaw pain at the School of Dentistry. All subjects were informed about the study by their operator and gave their written consent before starting the study. The protocol, design and implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry of the Andrés Bello University, Viña del Mar, Chile (Folio No. 033, October 2017). Which was in accordance with the latest version of the Declaration of Helsinki of the World Medical Association (World Medical Association Declaration of Helsinki, 2013).
Sample Size Calculation It was calculated according to a confidence level of 95% and a statistical power of 80%. Based on a previous study by Niemelä et al. (Niemelä et al., 2012) it was determined that the variance of the main variable (masticatory muscle pain) of the reference group is 2.6. In turn, the pain variable was measured on the visual analog scale (VAS), where a minimum clinically relevant difference was considered if a 3.5 point decrease was achieved on the VAS scale with respect to treatment, a reference that was also considered in this study.
Randomization and interventions. After meeting the inclusion and exclusion criteria, the subjects were randomly assigned to four groups through a computationally generated sequence "list randomizer" developed by random.org.
Evaluation methods The initial evaluation, to determine the degree of involvement of axis I, was carried out following the symptom questionnaire and clinical examination guidelines according to the DC / TMD protocol. Additionally, the questionnaire for the chronic pain degree scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC / TMD protocol were applied. In turn, an intraoral clinical examination was performed to exclude pain of dental origin. No subject was excluded for odontogenic pain.
Statistic analysis The demographic characteristics of the sample were reported descriptively. The data studied were tested to determine normality by using the Shapiro-Wilk and Doornik-Hansen tests, data that were parametric, so they were analyzed with a mixed ANOVA test, a factorial part and a repeated means part for the variables degree of chronic pain, masticatory muscle pain, mandibular range of motion, functional limitation and occlusal discomfort. The level of significance used was established at p 0.05. All statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 17 software (IBM, Chicago, USA).
- Conditions
- Myalgia of Mastication Muscle
- Being tested
- behavioral and self-care therapy, rigid occlusal splint (ROS), soft occlusal splint (SOS), non-occlusive splint (NOS)
- Keywords
- temporomandibular Joint Disorders, myalgia, occlusal splints, cognitive behavioral therapy, pain management
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral and self-care therapyBehavioural
Also called BST
It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state
rigid occlusal splint (ROS)Device
Also called ROS
Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).
soft occlusal splint (SOS)Device
Also called SOS
Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).
non-occlusive splint (NOS)Device
Also called NOS
non-occlusive splint formed under vacuum from individual sheets of rigid polyethylene terephthalate 2 mm thick (Biolon, Dreve, Unna, Germany), from which the occlusal surfaces were cut and incisal edges, allowing the usual occlusal contact of each subject.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral and self-care therapy control group | Active comparator | Subjects received verbal and written information on the etiology and prognosis of TMDs. In addition, advice on habits and behavior changes, relaxation techniques, sleep hygiene, diet modification, thermotherapy, encouragement to practice social and aerobic activities, and how to prevent risk factors and bad habits. Receives: Behavioral: behavioral and self-care therapy |
| Rigid occlusal splint group | Active comparator | Subjects in this group received behavioral and self-care therapy, in combination with a rigid occlusal splint Receives: Behavioral: behavioral and self-care therapy; Device: rigid occlusal splint (ROS) |
| Soft occlusal splint group | Active comparator | Subjects in this group received behavioral and self-care therapy, in combination with a soft occlusal splint Receives: Behavioral: behavioral and self-care therapy; Device: soft occlusal splint (SOS) |
| Non-occlusive splint group | Placebo comparator | Subjects in this group received behavioral and self-care therapy, in combination with a non-occlusive splint Receives: Behavioral: behavioral and self-care therapy; Device: non-occlusive splint (NOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory muscle pain initial evaluation
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Measured: It was applied in the initial evaluation
Masticatory muscle pain at 2 weeks
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Measured: It was applied in week 2 of intervention.
Masticatory muscle pain at 6 weeks
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Measured: It was applied in week 6 of intervention.
Masticatory muscle pain at 10 weeks
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Measured: It was applied in week 10 of intervention.
Secondary outcomes (10)
Mandibular range of movement initial evaluation
Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite
Measured: It was applied in the initial evaluation
Mandibular range of movement at 2 weeks
Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite
Measured: It was applied in week 2 of intervention.
Mandibular range of movement at 6 weeks
Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite
Measured: It was applied in week 6 of intervention.
Mandibular range of movement at 10 weeks
Maximum opening of the mouth in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge in the anterior teeth, compensating for the overbite
Measured: It was applied in week 10 of intervention.
Mandibular functional limitation initial
Scale in charge of globally assessing masticatory limitation, vertical mobility limitation, verbal and non-verbal communication limitation, included within a 20-item instrument thanks to the survey of mandibular functional limitation of the DC / TMD. This scale has a score of 0 to 10, with 10 being a severe limitation
Measured: It was applied in the initial evaluation
Mandibular functional limitation final
Scale in charge of globally assessing masticatory limitation, vertical mobility limitation, verbal and non-verbal communication limitation, included within a 20-item instrument thanks to the survey of mandibular functional limitation of the DC / TMD. This scale has a score of 0 to 10, with 10 being a severe limitation
Measured: It was applied in week 10 of intervention.
Grade of chronic pain
The evaluation of the chronicity of the painful clinical picture and the disability that it involves was measured using the Graded Chronic Pain Scale of the DC / TMD, where I = Low intensity pain , without disability; II = High intensity pain, without disability; III = Moderate disability; IV = Severe disability.
Measured: It was applied in the initial evaluation
Occlusal discomfort associated with an occlusal splint at 2 weeks
Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient.
Measured: It was applied in week 2 of intervention.
Occlusal discomfort associated with an occlusal splint at 6 weeks
Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient.
Measured: It was applied in week 6 of intervention.
Occlusal discomfort associated with an occlusal splint at 10 weeks
Scale responsible for evaluating adverse effects or discomfort of the subject to the occlusal splint during treatment, using a visual analog scale. This scale has a score of 0 to 10, with 10 being the greatest discomfort experienced by the patient.
Measured: It was applied in week 10 of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start16 Oct 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myalgia of Mastication MuscleStudies 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
- To protect the blinding of the study, it was carried out by two operators: A (examiner) and B (therapist). The treatment of the subjects consisted of 5 sessions: (1) evaluation and diagnosis of recruited subjects, and taking an impression of the upper jaw by operator A; (2) teaching BST and delivery of OS by operator B; (3) first treatment control and BST booster at 2 weeks; (4) second treatment control and BST booster at 6 weeks; (5) third control of treatment and removal of OS if it corresponds to 10 weeks. All controls were performed by operator A in order to use a blind design without the knowledge of the outcome assessor. To protect this, it is explained to the subject that operator A cannot know the treatment that was delivered. Operator B delivered the treatments at random among the subjects selected by operator A after the initial examination, being himself in charge of contacting them and delivering the corresponding treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Salinas Aguilar, Universidad Nacional Andres Bello
- Investigators
- Diego I De Nordenflycht, Principal investigator, Universidad Nacional Andrés Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588636
- Sponsor's protocol ID
- 10.17605/OSF.IO/9XTMD
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the collected individual participant data (IPD), study protocol, statistical analysis plan, informed consent form and a clinical study report will be shared, including results, discussion and bibliography studied.
Publications
Niemela K, Korpela M, Raustia A, Ylostalo P, Sipila K. Efficacy of stabilisation splint treatment on temporomandibular disorders. J Oral Rehabil. 2012 Nov;39(11):799-804. doi: 10.1111/j.1365-2842.2012.02335.x. Epub 2012 Jul 19.
PubMed 22809314
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain: a Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04588636
- Acronym / sponsor ID
- 10.17605/OSF.IO/9XTMD
- Conditions
- Myalgia of Mastication Muscle
- Keywords
- temporomandibular Joint Disorders, myalgia, occlusal splints, cognitive behavioral therapy, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 19 Oct 2020 (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.
The objective of this study was to compare the clinical effectiveness of personalized thermoformed occlusal splints together with behavioral and self-care therapy in the management of myalgia of the masticatory muscles. A controlled clinical trial was carried out with a total of 46 subjects diagnosed with myalgia according to the diagnostic criteria for temporomandibular disorders (DC / TMD). All subjects were treated with behavioral and self-care therapy (BST) at the beginning of the study, and were then randomized into 4 groups: behavioral and self-care control group; rigid occlusal splint group; soft occlusal splint group and non-occlusive splint group. Follow-ups were carried out at 2, 6 and 10 weeks, where it was evaluated: pain in the masticatory muscles, mandibular range of motion, mandibular functional limitation and occlusal discomfort.
Detailed description
Materials and method This randomized controlled clinical trial was conducted between October 2017 and January 2018 at the Dental Clinic of the Andrés Bello University (Viña del Mar, Chile). The study subjects were recruited from the universe of patients seeking treatment for jaw pain at the School of Dentistry. All subjects were informed about the study by their operator and gave their written consent before starting the study. The protocol, design and implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry of the Andrés Bello University, Viña del Mar, Chile (Folio No. 033, October 2017). Which was in accordance with the latest version of the Declaration of Helsinki of the World Medical Association (World Medical Association Declaration of Helsinki, 2013).
Sample Size Calculation It was calculated according to a confidence level of 95% and a statistical power of 80%. Based on a previous study by Niemelä et al. (Niemelä et al., 2012) it was determined that the variance of the main variable (masticatory muscle pain) of the reference group is 2.6. In turn, the pain variable was measured on the visual analog scale (VAS), where a minimum clinically relevant difference was considered if a 3.5 point decrease was achieved on the VAS scale with respect to treatment, a reference that was also considered in this study.
Randomization and interventions. After meeting the inclusion and exclusion criteria, the subjects were randomly assigned to four groups through a computationally generated sequence "list randomizer" developed by random.org.
Evaluation methods The initial evaluation, to determine the degree of involvement of axis I, was carried out following the symptom questionnaire and clinical examination guidelines according to the DC / TMD protocol. Additionally, the questionnaire for the chronic pain degree scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC / TMD protocol were applied. In turn, an intraoral clinical examination was performed to exclude pain of dental origin. No subject was excluded for odontogenic pain.
Statistic analysis The demographic characteristics of the sample were reported descriptively. The data studied were tested to determine normality by using the Shapiro-Wilk and Doornik-Hansen tests, data that were parametric, so they were analyzed with a mixed ANOVA test, a factorial part and a repeated means part for the variables degree of chronic pain, masticatory muscle pain, mandibular range of motion, functional limitation and occlusal discomfort. The level of significance used was established at p 0.05. All statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 17 software (IBM, Chicago, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- To protect the blinding of the study, it was carried out by two operators: A (examiner) and B (therapist). The treatment of the subjects consisted of 5 sessions: (1) evaluation and diagnosis of recruited subjects, and taking an impression of the upper jaw by operator A; (2) teaching BST and delivery of OS by operator B; (3) first treatment control and BST booster at 2 weeks; (4) second treatment control and BST booster at 6 weeks; (5) third control of treatment and removal of OS if it corresponds to 10 weeks. All controls were performed by operator A in order to use a blind design without the knowledge of the outcome assessor. To protect this, it is explained to the subject that operator A cannot know the treatment that was delivered. Operator B delivered the treatments at random among the subjects selected by operator A after the initial examination, being himself in charge of contacting them and delivering the corresponding treatment.
| Arm | Type | Receives |
|---|---|---|
| Behavioral and self-care therapy control group | Active comparator | Behavioral: behavioral and self-care therapySubjects received verbal and written information on the etiology and prognosis of TMDs. In addition, advice on habits and behavior changes, relaxation techniques, sleep hygiene, diet modification, thermotherapy, encouragement to practice social and aerobic activities, and how to prevent risk factors and bad habits. |
| Rigid occlusal splint group | Active comparator | Behavioral: behavioral and self-care therapy, Device: rigid occlusal splint (ROS)Subjects in this group received behavioral and self-care therapy, in combination with a rigid occlusal splint |
| Soft occlusal splint group | Active comparator | Behavioral: behavioral and self-care therapy, Device: soft occlusal splint (SOS)Subjects in this group received behavioral and self-care therapy, in combination with a soft occlusal splint |
| Non-occlusive splint group | Placebo comparator | Behavioral: behavioral and self-care therapy, Device: non-occlusive splint (NOS)Subjects in this group received behavioral and self-care therapy, in combination with a non-occlusive splint |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 40 years
- Presence of myalgia of the masticatory muscles with or without limitation of the mouth opening according to DC / TMD diagnostic criteria
Key exclusion criteria (8 listed)
- Painful joint TMD
- History of treatment for TMD
- Recent history of facial or cervical trauma
- Current orthodontic treatment
- Tooth mobility secondary to periodontal disease
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 |
|---|---|---|
| behavioral and self-care therapyAlso: BSTIt is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state | Behavioural | Behavioral and self-care therapy control group, Non-occlusive splint group, Rigid occlusal splint group, Soft occlusal splint group |
| rigid occlusal splint (ROS)Also: ROSOcclusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany). | Device | Rigid occlusal splint group |
| soft occlusal splint (SOS)Also: SOSOcclusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany). | Device | Soft occlusal splint group |
| non-occlusive splint (NOS)Also: NOSnon-occlusive splint formed under vacuum from individual sheets of rigid polyethylene terephthalate 2 mm thick (Biolon, Dreve, Unna, Germany), from which the occlusal surfaces were cut and incisal edges, allowing the usual occlusal contact of each subject. | Device | Non-occlusive splint group |
Primary outcome
Masticatory muscle pain initial evaluation
Time frame: It was applied in the initial evaluation
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Masticatory muscle pain at 2 weeks
Time frame: It was applied in week 2 of intervention.
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Masticatory muscle pain at 6 weeks
Time frame: It was applied in week 6 of intervention.
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
Masticatory muscle pain at 10 weeks
Time frame: It was applied in week 10 of intervention.
Pain intensity was measured using a visual analog scale. Subjects were asked to mark the intensity of pain perceived at the time of examination. This scale has a score from 0 to 10, with 10 being the greatest pain experienced by the patient
10 secondary outcomes
Mandibular range of movement initial evaluation
Time frame: It was applied in the initial evaluation
Mandibular range of movement at 2 weeks
Time frame: It was applied in week 2 of intervention.
Mandibular range of movement at 6 weeks
Time frame: It was applied in week 6 of intervention.
Mandibular range of movement at 10 weeks
Time frame: It was applied in week 10 of intervention.
Mandibular functional limitation initial
Time frame: It was applied in the initial evaluation
Mandibular functional limitation final
Time frame: It was applied in week 10 of intervention.
Grade of chronic pain
Time frame: It was applied in the initial evaluation
Occlusal discomfort associated with an occlusal splint at 2 weeks
Time frame: It was applied in week 2 of intervention.
Occlusal discomfort associated with an occlusal splint at 6 weeks
Time frame: It was applied in week 6 of intervention.
Occlusal discomfort associated with an occlusal splint at 10 weeks
Time frame: It was applied in week 10 of intervention.
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 19 Oct 2020.
- Background: PubMed 22809314Niemela K, Korpela M, Raustia A, Ylostalo P, Sipila K. Efficacy of stabilisation splint treatment on temporomandibular disorders. J Oral Rehabil. 2012 Nov;39(11):799-804. doi: 10.1111/j.1365-2842.2012.02335.x. Epub 2012 Jul 19.
- The DC/TMD is intended for use in both clinical settings and applied research settings.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All the collected individual participant data (IPD), study protocol, statistical analysis plan, informed consent form and a clinical study report will be shared, including results, discussion and bibliography studied.
Related trials for Myalgia of Mastication Muscle
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Enrolling by invitationObservational study
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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.
Diego I De Nordenflycht principal investigator
Universidad Nacional Andrés Bello
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral and self-care therapy, rigid occlusal splint (ROS) and soft occlusal splint (SOS) in people with Myalgia of Mastication Muscle, run by Universidad Nacional Andres Bello at 1 site in Chile.
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 8 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 19 Oct 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Masticatory muscle pain initial evaluation (time frame: It was applied in the initial evaluation). 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?
On the ClinicalTrials.gov record for NCT04588636, which also lists 1 linked publication.
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 19 Oct 2020.