TMDNCT06339736
Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
An observational study of TMD and TMD/Orofacial Pain, run by University of Pisa at 1 site in Italy.
Trial summary
The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TMD, TMD/Orofacial Pain
- What is being tested?
- Questionnaires administered to all study participants
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 28 Mar 2025
- Phase
- Observational
- 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
Study population: Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD
Who may be able to join
- males or females >18 years of age
- systemically healthy patients
- clinical examination revealing a diagnosis of muscular temporo-mandibular joint disorder (TMD) and/or positive history of muscular TMD
- patients willing to give informed consent, and v) compliance to the study follow-up.
Who cannot join
- articular TMDs
- chronic diseases
- any psychiatric diagnosis under medication
- pregnant or lactating females
- not willing to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.
Read the detailed description
Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD between January 2022 and December 2022 were enrolled. All the study participants signed an informed consent form to be included in the study.
Two study groups were identified:
- M-TMD group, including patients with a diagnosis of muscular TMDs;
- A control group of subjects with a negative history for TMDs. The inclusion criteria for patients in the M-TMD group were i) males or females \>18 years, ii) systemically healthy patients, iii) clinical examination revealing a diagnosis of muscular TMD and/or positive history of muscular TMD, iv) patients willing to give informed consent, and v) compliance to the study follow-up. Patients with i) articular TMDs, ii) chronic diseases, iii) any psychiatric diagnosis under medication, iv) pregnant or lactating, and v) not willing to comply with the study protocol were excluded.
The subjects included in the control group were enrolled among the patients referred to the Unit of Oral Surgery of the Unit of Dentistry and Oral Surgery. The patients in the control group were i) males or females of age \> 18 years, ii) systemically healthy patients, iii) clinical examination negative for pain in the masticatory muscles and negative for history of TMDs, and iv) patients willing to give informed consent and to be administered the study questionnaires.
After diagnosis confirmation of M-TMD according to the DC/TMD criteria, the patients were treated with the application of an oral splint on the upper dental arch associated with physio-kinesiotherapy.
The patients were administered OHIP-14, PHQ-9, and GAD-7 questionnaires to compare scores in the M-TMD patients versus healthy subjects
- Conditions
- TMD, TMD/Orofacial Pain
- Being tested
- Questionnaires administered to all study participants
- Keywords
- Temporomandibular Joint Disorders, Quality of Life, Oral Health, Oral Health-Related Quality of Life
- 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.
Questionnaires administered to all study participantsOther
Ten treatment sessions were performed, which initially involved muscular stretching and relaxation exercises and then strengthening and endurance exercises to achieve stabilization. An oral splint was applied to he upper dental arch.
| Study group | Role | What they receive |
|---|---|---|
| M-TMD group | Patients with a diagnosis of muscular TMDs performed according to DC/TMD criteria Receives: Other: Questionnaires administered to all study participants | |
| CTRL group | A control group of subjects with a negative history for TMDs Receives: Other: Questionnaires administered to all study participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of muscular pain on oral health
Assessment of Oral Health Impact Profile -14 (OHIP-14) questionnaire scores following treatment. Scores range between 0 (absence of oral health impairment) and 56 (severe oral health impact)
Measured: 6 months
Evaluation of the impact of muscular pain on anxiety
Assessment of General Anxiety Disorder-7 (GAD-7) questionnaire scores following treatment. Scores range from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Measured: 6 months
Evaluation of the impact of muscular pain on depression
Assessment of Patient Health Questionnaire-9 (PHQ-9) questionnaire scores following treatment. score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)
Measured: 6 months
Secondary outcomes (1)
Changes in muscular pain
Changes in muscular pain following treatment assessed through pressure pain threshold
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start10 Jan 2022
- Primary completion28 Feb 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Izzetti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339736
- Sponsor's protocol ID
- 23815
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT06339736
- Acronym / sponsor ID
- 23815
- Conditions
- TMD, TMD/Orofacial Pain
- Keywords
- Temporomandibular Joint Disorders, Quality of Life, Oral Health, Oral Health-Related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 1 Apr 2024 (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 the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.
Detailed description
Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD between January 2022 and December 2022 were enrolled. All the study participants signed an informed consent form to be included in the study.
Two study groups were identified:
- M-TMD group, including patients with a diagnosis of muscular TMDs;
- A control group of subjects with a negative history for TMDs. The inclusion criteria for patients in the M-TMD group were i) males or females \>18 years, ii) systemically healthy patients, iii) clinical examination revealing a diagnosis of muscular TMD and/or positive history of muscular TMD, iv) patients willing to give informed consent, and v) compliance to the study follow-up. Patients with i) articular TMDs, ii) chronic diseases, iii) any psychiatric diagnosis under medication, iv) pregnant or lactating, and v) not willing to comply with the study protocol were excluded.
The subjects included in the control group were enrolled among the patients referred to the Unit of Oral Surgery of the Unit of Dentistry and Oral Surgery. The patients in the control group were i) males or females of age \> 18 years, ii) systemically healthy patients, iii) clinical examination negative for pain in the masticatory muscles and negative for history of TMDs, and iv) patients willing to give informed consent and to be administered the study questionnaires.
After diagnosis confirmation of M-TMD according to the DC/TMD criteria, the patients were treated with the application of an oral splint on the upper dental arch associated with physio-kinesiotherapy.
The patients were administered OHIP-14, PHQ-9, and GAD-7 questionnaires to compare scores in the M-TMD patients versus healthy subjects
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TMD group | – | Other: Questionnaires administered to all study participantsPatients with a diagnosis of muscular TMDs performed according to DC/TMD criteria |
| CTRL group | – | Other: Questionnaires administered to all study participantsA control group of subjects with a negative history for TMDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD
Key inclusion criteria (4 listed)
- males or females >18 years of age
- systemically healthy patients
- clinical examination revealing a diagnosis of muscular temporo-mandibular joint disorder (TMD) and/or positive history of muscular TMD
- patients willing to give informed consent, and v) compliance to the study follow-up.
Key exclusion criteria (5 listed)
- articular TMDs
- chronic diseases
- any psychiatric diagnosis under medication
- pregnant or lactating females
- not willing to comply with the study protocol
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 |
|---|---|---|
| Questionnaires administered to all study participantsTen treatment sessions were performed, which initially involved muscular stretching and relaxation exercises and then strengthening and endurance exercises to achieve stabilization. An oral splint was applied to he upper dental arch. | Other | CTRL group, M-TMD group |
Primary outcome
Evaluation of the impact of muscular pain on oral health
Time frame: 6 months
Assessment of Oral Health Impact Profile -14 (OHIP-14) questionnaire scores following treatment. Scores range between 0 (absence of oral health impairment) and 56 (severe oral health impact)
Evaluation of the impact of muscular pain on anxiety
Time frame: 6 months
Assessment of General Anxiety Disorder-7 (GAD-7) questionnaire scores following treatment. Scores range from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Evaluation of the impact of muscular pain on depression
Time frame: 6 months
Assessment of Patient Health Questionnaire-9 (PHQ-9) questionnaire scores following treatment. score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)
1 secondary outcome
Changes in muscular pain
Time frame: 6 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 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of TMD and TMD/Orofacial Pain, run by University of Pisa 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 5 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 3 Apr 2025. 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?
Evaluation of the impact of muscular pain on oral health (time frame: 6 months). The study lists 3 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 3 Apr 2025.