Temporomandibular DisorderNCT03726060
Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
A study testing test group in people with Temporomandibular Disorder, run by Paolo Pillastrini at 1 site in Italy.
Trial summary
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders. They will enrolled 100 patient which will be divided into two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- test group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2018to 31 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
- patients older than 18 years;
- good knowledge of Italian language;
- patients who have signed informed consent
Who cannot join
- edentulism which makes it impossible to apply gnathological bite;
- patients with psychiatric problems;
- patients included in other experimental protocols;
- patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
- other temporomandibular disorders without a myogenic component;
- treatment of the cervical and TMJ district in the previous 3 months;
- history of drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.
They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).
The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
Read the detailed description
Randomized controlled clinical trial with randomization according to a multi-phase design.
Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.
Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.
Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.
The 2 therapeutic protocols are:
- gnathological therapy (splint) associated with education and physiotherapy (test group);
- gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.
The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).
Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.
Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.
Both types of treatment will be performed by a single operator respectively.
- Conditions
- Temporomandibular Disorder
- Being tested
- control group, test group
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
Also called splint therapy
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
test groupOther
Also called splint therapy with physical therapy
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
| Study group | Role | What they receive |
|---|---|---|
| splint therapy | Other | Alginate impressions will be taken and the plaster models of the dental arches will be made.
The splint will be subsequently delivered to the patient with the relative indications of use.
The splint therapy consist in the use of neuromuscoral splint every the night for 6 months. Receives: Other: control group |
| physical therapy with splint therapy | Other | The treatment consists of a series of interventions: advice on self-treatment techniques to be performed at home and administering manual therapy techniques addressed to: temporomandibular district, cervical and cervico-thoracic junction.
Each session will be carried out individually and will last for 45 minutes. This duration will be divided as follows: 25 minutes dedicated to the temporomandibular district, 15 minutes to the cervical and cervico-thoracic junction, 5 minutes to teaching self-treatment techniques to be carried out at home and to verify the correct way of performing them.
The cycle will consist of 10 sessions distributed over 3 months. Receives: Other: test group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
Measured: Change from initial VAS at 3 and 6 months from the beginning of the treatment
Secondary outcomes (1)
ROM (range of motion)
The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups.
It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite.
It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)
Measured: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start31 Oct 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Pillastrini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Pillastrini, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726060
- Sponsor's protocol ID
- 47/2018/SPER/AUSLBO
- Status last verified
- May 2022
- First submitted
- 24 Oct 2018
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romeo A, Incorvati C, Vanti C, Turolla A, Marinelli F, Defila L, Gulotta C, Marchetti C, Pillastrini P. Physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: A randomised controlled trial. J Oral Rehabil. 2024 Aug;51(8):1566-1578. doi: 10.1111/joor.13729. Epub 2024 May 17.
PubMed 38757854Incorvati C, Romeo A, Fabrizi A, Defila L, Vanti C, Gatto MRA, Marchetti C, Pillastrini P. Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e038438. doi: 10.1136/bmjopen-2020-038438.
PubMed 32792449
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT03726060
- Acronym / sponsor ID
- 47/2018/SPER/AUSLBO
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Paolo PillastriniUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 31 Oct 2018 (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 aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.
They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).
The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
Detailed description
Randomized controlled clinical trial with randomization according to a multi-phase design.
Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.
Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.
Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.
The 2 therapeutic protocols are:
- gnathological therapy (splint) associated with education and physiotherapy (test group);
- gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.
The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).
Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.
Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.
Both types of treatment will be performed by a single operator respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| splint therapy | Other | Other: control groupAlginate impressions will be taken and the plaster models of the dental arches will be made. The splint will be subsequently delivered to the patient with the relative indications of use. The splint therapy consist in the use of neuromuscoral splint every the night for 6 months. |
| physical therapy with splint therapy | Other | Other: test groupThe treatment consists of a series of interventions: advice on self-treatment techniques to be performed at home and administering manual therapy techniques addressed to: temporomandibular district, cervical and cervico-thoracic junction. Each session will be carried out individually and will last for 45 minutes. This duration will be divided as follows: 25 minutes dedicated to the temporomandibular district, 15 minutes to the cervical and cervico-thoracic junction, 5 minutes to teaching self-treatment techniques to be carried out at home and to verify the correct way of performing them. The cycle will consist of 10 sessions distributed over 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
- patients older than 18 years;
- good knowledge of Italian language;
- patients who have signed informed consent
Key exclusion criteria (7 listed)
- edentulism which makes it impossible to apply gnathological bite;
- patients with psychiatric problems;
- patients included in other experimental protocols;
- patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
- other temporomandibular disorders without a myogenic component;
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 |
|---|---|---|
| control groupAlso: splint therapyIn the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months | Other | splint therapy |
| test groupAlso: splint therapy with physical therapyIn the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy | Other | physical therapy with splint therapy |
Primary outcome
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
Time frame: Change from initial VAS at 3 and 6 months from the beginning of the treatment
The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
1 secondary outcome
ROM (range of motion)
Time frame: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
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 31 May 2022.
- Derived from this study: PubMed 38757854Romeo A, Incorvati C, Vanti C, Turolla A, Marinelli F, Defila L, Gulotta C, Marchetti C, Pillastrini P. Physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: A randomised controlled trial. J Oral Rehabil. 2024 Aug;51(8):1566-1578. doi: 10.1111/joor.13729. Epub 2024 May 17.
- Derived from this study: PubMed 32792449Incorvati C, Romeo A, Fabrizi A, Defila L, Vanti C, Gatto MRA, Marchetti C, Pillastrini P. Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e038438. doi: 10.1136/bmjopen-2020-038438.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test group in people with Temporomandibular Disorder, run by Paolo Pillastrini at 1 site in Italy.
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 4 inclusion and 7 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 31 May 2022. 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 Italy. 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?
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain (time frame: Change from initial VAS at 3 and 6 months from the beginning of the treatment). 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 NCT03726060, which also lists 2 linked publications.
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 31 May 2022.