C05.500.607.221.897NCT06041633
Preliminary Assessment of the Psycho-emotional State of Patients With TMD
An observational study of C05.500.607.221.897 and C05.550.905, run by Jagiellonian University at 1 site in Poland.
Trial summary
TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that includes abnormal function of the muscles of mastication, the temporomandibular joints and surrounding structures. It is one of the most significant causes of orofacial pain, along with dental pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- C05.500.607.221.897, C05.550.905
- What is being tested?
- Clinical
- How many people
- 260 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2021to 30 Oct 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Population of Patients of University Clinic
Who may be able to join
- good general health, with no craniofacial trauma in the last 5 years and without severe mental conditions (ii) the presence of TMD symptoms (pain in the masticatory muscles, limitation of mouth opening range, clicking or popping in the temporomandibular joints. For control group there was absences of these symptoms.
- consent of the patient to participate in the research project
- The exclusion criteria for the study were:
- -
Who cannot join
- (i). willingness to resign out of the study.
- -
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecka Klinika Stomatologiczna
Krakow, 31-155
Andrzej Gala, Dr, +48124245555 ext. 230, andrzej.gala@uj.edu.pl
About this study
TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that includes abnormal function of the muscles of mastication, the temporomandibular joints and surrounding structures. It is one of the most significant causes of orofacial pain, along with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the masticatory muscles rather than primary changes in the joints themselves.
Nowadays, doctors who treat patients with TMD have no doubt that one of the very important etiological factors of this condition is psycho-emotional disorders (excessive nervous excitability, anxiety, depression), which has been confirmed by numerous authors of studies on this subject [4-11].
Read more
The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to the development of the disorder. An important factor affecting the state of masticatory function is an increase in stress levels (psycho-emotional tension). Structures such as the hypothalamus, reticular formation and limbic system have a decisive influence on the emotional state of each patient The activity of the limbic system, which governs the emotions of adults, and the additional connections of the gamma loops to the masticatory muscles, determine that increased emotional tension translates into a significant increase in the "contractile" activity of the masticatory muscles.
TMD and functional disorder of the masticatory muscles are the most common complaint of the patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is related to vasocontraction of relevant arteries and accumulation of metabolic waste product in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on the masticatory muscles and temporomandibular joints.
- Conditions
- C05.500.607.221.897, C05.550.905
- Being tested
- Clinical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinicalDiagnostic test
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Clinical | One hundred and thirty patients diagnosed with TMD constituted the study group (group I) Receives: Diagnostic Test: Clinical | |
| Control | One hundred and thirty patients were excluded from having TMD based on the RDC/ TMD questionnaire, and these patients constituted the control group (group II). Receives: Diagnostic Test: Clinical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionanire
The questionnaire survey includes a total of 30 questions, regarding the emotional state of the of the respondents over the past 4 weeks such as lowered mood, states of emotional irritability, feelings of sadness, lack of desire for daily activities, lack of concentration, or desire for self-isolation and critical thoughts toward one's own person person, or nervousness, fearfulness. Responses in each question included: * no, * a few times in the past 4 weeks, *a few times during the week, and *continuously/continually. The scores for each question were: 0 points for most favorable response and 4 points for the most unfavorable patient response. The result of the questionnaire was divided into four sections; A, B, C,D.
Measured: 2021-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Oct 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
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 C05.500.607.221.897Studies 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
- Retrospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malgorzata Pihut, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041633
- Sponsor's protocol ID
- 1072.6120.312.2021-15.12.2
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pihut ME, Kostrzewa-Janicka J, Orczykowska M, Bieganska-Banas J, Gibas-Stanek M, Gala A. Initial assessment of the psycho-emotional state of patients with temporomandibular disorders: A pilot study. Dent Med Probl. 2024 Jan-Feb;61(1):153-159. doi: 10.17219/dmp/178325.
PubMed 38441313
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Psycho-emotional State of Patients With TMD
- ClinicalTrials.gov ID
- NCT06041633
- Acronym / sponsor ID
- 1072.6120.312.2021-15.12.2
- Conditions
- C05.500.607.221.897, C05.550.905
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 18 Sep 2023 (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.
TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that includes abnormal function of the muscles of mastication, the temporomandibular joints and surrounding structures. It is one of the most significant causes of orofacial pain, along with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the masticatory muscles rather than primary changes in the joints themselves.
Nowadays, doctors who treat patients with TMD have no doubt that one of the very important etiological factors of this condition is psycho-emotional disorders (excessive nervous excitability, anxiety, depression), which has been confirmed by numerous authors of studies on this subject [4-11].
The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to the development of the disorder. An important factor affecting the state of masticatory function is an increase in stress levels (psycho-emotional tension). Structures such as the hypothalamus, reticular formation and limbic system have a decisive influence on the emotional state of each patient The activity of the limbic system, which governs the emotions of adults, and the additional connections of the gamma loops to the masticatory muscles, determine that increased emotional tension translates into a significant increase in the "contractile" activity of the masticatory muscles.
TMD and functional disorder of the masticatory muscles are the most common complaint of the patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is related to vasocontraction of relevant arteries and accumulation of metabolic waste product in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on the masticatory muscles and temporomandibular joints.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical | – | Diagnostic Test: ClinicalOne hundred and thirty patients diagnosed with TMD constituted the study group (group I) |
| Control | – | Diagnostic Test: ClinicalOne hundred and thirty patients were excluded from having TMD based on the RDC/ TMD questionnaire, and these patients constituted the control group (group II). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Population of Patients of University Clinic
Key inclusion criteria (4 listed)
- good general health, with no craniofacial trauma in the last 5 years and without severe mental conditions (ii) the presence of TMD symptoms (pain in the masticatory muscles, limitation of mouth opening range, clicking or popping in the temporomandibular joints. For control group there was absences of these symptoms.
- consent of the patient to participate in the research project
- -
Key exclusion criteria (2 listed)
- (i). willingness to resign out of the study.
- -
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 |
|---|---|---|
| ClinicalQuestionnaire | Diagnostic test | Clinical, Control |
Primary outcome
Questionanire
Time frame: 2021-2023
The questionnaire survey includes a total of 30 questions, regarding the emotional state of the of the respondents over the past 4 weeks such as lowered mood, states of emotional irritability, feelings of sadness, lack of desire for daily activities, lack of concentration, or desire for self-isolation and critical thoughts toward one's own person person, or nervousness, fearfulness. Responses in each question included: * no, * a few times in the past 4 weeks, *a few times during the week, and *continuously/continually. The scores for each question were: 0 points for most favorable response and 4 points for the most unfavorable patient response. The result of the questionnaire was divided into four sections; A, B, C,D.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 38441313Pihut ME, Kostrzewa-Janicka J, Orczykowska M, Bieganska-Banas J, Gibas-Stanek M, Gala A. Initial assessment of the psycho-emotional state of patients with temporomandibular disorders: A pilot study. Dent Med Probl. 2024 Jan-Feb;61(1):153-159. doi: 10.17219/dmp/178325.
- Individual participant dataSharing planned: No
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.
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 C05.500.607.221.897 and C05.550.905, run by Jagiellonian University at 1 site in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Gala, Dr (48124245555 ext. 230, andrzej.gala@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionanire (time frame: 2021-2023). 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 NCT06041633, 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 18 Sep 2023.