Diabete Type 2NCT06188572
The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality
An observational study of Diabete Type 2, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 48 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Michigan Neuropathy Screening Instrument, Numeric Pain Scale and Mandibular Function Disorder Questionnaire
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 Nov 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 48 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group included individuals aged between 48-78 (min-max) years who were diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital, while the control group included age and gender homogeneous healthy individuals without a diagnosis of DM.
Who may be able to join
- Individuals diagnosed with type 2 DM
Who cannot join
- Having diabetic foot ulcer,
- Mini Mental Test score below 24,
- History of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic disease, facial paralysis, surgical operation related to spine, abdomen and/or TMJ problem
- Receiving any treatment related to spine and TMJ in less than 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University
Balıkesir, Bandirma
About this study
Official title: The Effect of Diabetic Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality in Patients With Type 2 Diabetes
The aim of this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes.
Read the detailed description
The number of participants planned to be included in the study was decided with the G-Power programme. While calculating the number of individuals to be included in the study, it was calculated that the sample size to obtain an effect size of 0.6 for the purpose of evaluation within the 95% confidence interval in a way to provide 80% study power at 5% Type 1 and 20% Type 2 error limits should be 74 (n=37) individuals. This study included 70 individuals (DM study group=40 individuals, control group=30 individuals).
Peripheral neuropathy symptoms of all participants were evaluated with the Michigan Neuropathy Screening Test. In the evaluation of TMJ functionality, the presence of pain, maximum pain-free mouth opening, mandibular dysfunction and dysfunction were assessed with the help of scales. Duration of diabetes mellitus was recorded and quality of life was evaluated with Ferran Powers Quality of Life Index.
- Conditions
- Diabete Type 2
- Being tested
- Michigan Neuropathy Screening Instrument, Numeric Pain Scale, Mandibular Function Disorder Questionnaire, Fonseca Anamnestic Index, Ferrans&Powers Quality of Life Index Diabetes Version
- Keywords
- diabetes mellitus, temporomandibular joint, neuropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Michigan Neuropathy Screening InstrumentOther
A two-step test consisting of symptom questionnaire and physical examination was used. The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests.
Numeric Pain ScaleOther
In this simple method, which is frequently used to measure pain intensity in the clinic and whose validity and reliability have been demonstrated, the participant is asked to mark a number on a 10 cm scale with numbers ranging from "0" (no pain) to "10" (unbearable pain) for the pain.
Mandibular Function Disorder QuestionnaireOther
This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function
Fonseca Anamnestic IndexOther
This scale, which is valid and reliable as a TMJ disorder assessment tool, includes 10 questions. The presence of TMD is accepted in those with a score of 25.
Ferrans&Powers Quality of Life Index Diabetes VersionOther
This index consists of two parts and a total of 68 items. A high score indicates a good quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus | The study group included individuals aged 48-78 (min-max) years, diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital. Receives: Other: Michigan Neuropathy Screening Instrument; Other: Numeric Pain Scale; Other: Mandibular Function Disorder Questionnaire; Other: Fonseca Anamnestic Index; Other: Ferrans&Powers Quality of Life Index Diabetes Version | |
| Healthy | Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group Receives: Other: Michigan Neuropathy Screening Instrument; Other: Numeric Pain Scale; Other: Mandibular Function Disorder Questionnaire; Other: Fonseca Anamnestic Index; Other: Ferrans&Powers Quality of Life Index Diabetes Version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Neuropathy Screening Instrument
The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests.
High score indicates increased neuropathy
Measured: May 2023- November 2023
Numeric Pain Scale
The participant is asked to mark a number on a 10 cm scale, on which numbers are shown in the range of "0" (no pain) to "10" (unbearable pain) for the pain. High score indicates increased pain
Measured: May 2023- November 2023
Maximum pain-free mouth opening
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Measured: May 2023- November 2023
Mandibular Function Disorder Questionnaire
This scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
Measured: May 2023- November 2023
Fonseca Anamnestic Index
This scale includes 10 questions. The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.
Measured: May 2023- November 2023
Ferrans&Powers Quality of Life Index Diabetes Version
The Quality of Life Assessment Index consists of two parts and a total of 68 items. A high score indicates a good quality of life
Measured: May 2023- November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 May 2023
- Primary completion1 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188572
- Sponsor's protocol ID
- HRU/23.04.15
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetic Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06188572
- Acronym / sponsor ID
- HRU/23.04.15
- Conditions
- Diabete Type 2
- Keywords
- diabetes mellitus, temporomandibular joint, neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 3 Jan 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 this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes.
Detailed description
The number of participants planned to be included in the study was decided with the G-Power programme. While calculating the number of individuals to be included in the study, it was calculated that the sample size to obtain an effect size of 0.6 for the purpose of evaluation within the 95% confidence interval in a way to provide 80% study power at 5% Type 1 and 20% Type 2 error limits should be 74 (n=37) individuals. This study included 70 individuals (DM study group=40 individuals, control group=30 individuals).
Peripheral neuropathy symptoms of all participants were evaluated with the Michigan Neuropathy Screening Test. In the evaluation of TMJ functionality, the presence of pain, maximum pain-free mouth opening, mandibular dysfunction and dysfunction were assessed with the help of scales. Duration of diabetes mellitus was recorded and quality of life was evaluated with Ferran Powers Quality of Life Index.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus | – | Other: Michigan Neuropathy Screening Instrument, Other: Numeric Pain Scale, Other: Mandibular Function Disorder Questionnaire, Other: Fonseca Anamnestic Index, Other: Ferrans&Powers Quality of Life Index Diabetes VersionThe study group included individuals aged 48-78 (min-max) years, diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital. |
| Healthy | – | Other: Michigan Neuropathy Screening Instrument, Other: Numeric Pain Scale, Other: Mandibular Function Disorder Questionnaire, Other: Fonseca Anamnestic Index, Other: Ferrans&Powers Quality of Life Index Diabetes VersionAge and sex homogenous healthy individuals without a diagnosis of DM were included in the control group |
Who may qualify
- Ages
- 48 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group included individuals aged between 48-78 (min-max) years who were diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital, while the control group included age and gender homogeneous healthy individuals without a diagnosis of DM.
Key inclusion criteria (1 listed)
- Individuals diagnosed with type 2 DM
Key exclusion criteria (4 listed)
- Having diabetic foot ulcer,
- Mini Mental Test score below 24,
- History of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic disease, facial paralysis, surgical operation related to spine, abdomen and/or TMJ problem
- Receiving any treatment related to spine and TMJ in less than 6 months
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 |
|---|---|---|
| Michigan Neuropathy Screening InstrumentA two-step test consisting of symptom questionnaire and physical examination was used. The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests. | Other | Diabetes Mellitus, Healthy |
| Numeric Pain ScaleIn this simple method, which is frequently used to measure pain intensity in the clinic and whose validity and reliability have been demonstrated, the participant is asked to mark a number on a 10 cm scale with numbers ranging from "0" (no pain) to "10" (unbearable pain) for the pain. | Other | Diabetes Mellitus, Healthy |
| Mandibular Function Disorder QuestionnaireThis valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function | Other | Diabetes Mellitus, Healthy |
| Fonseca Anamnestic IndexThis scale, which is valid and reliable as a TMJ disorder assessment tool, includes 10 questions. The presence of TMD is accepted in those with a score of 25. | Other | Diabetes Mellitus, Healthy |
| Ferrans&Powers Quality of Life Index Diabetes VersionThis index consists of two parts and a total of 68 items. A high score indicates a good quality of life. | Other | Diabetes Mellitus, Healthy |
Primary outcome
Michigan Neuropathy Screening Instrument
Time frame: May 2023- November 2023
The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests. High score indicates increased neuropathy
Numeric Pain Scale
Time frame: May 2023- November 2023
The participant is asked to mark a number on a 10 cm scale, on which numbers are shown in the range of "0" (no pain) to "10" (unbearable pain) for the pain. High score indicates increased pain
Maximum pain-free mouth opening
Time frame: May 2023- November 2023
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Mandibular Function Disorder Questionnaire
Time frame: May 2023- November 2023
This scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
Fonseca Anamnestic Index
Time frame: May 2023- November 2023
This scale includes 10 questions. The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.
Ferrans&Powers Quality of Life Index Diabetes Version
Time frame: May 2023- November 2023
The Quality of Life Assessment Index consists of two parts and a total of 68 items. A high score indicates a good quality of life
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 5 Jan 2024.
- 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 Diabete Type 2, run by Bandırma Onyedi Eylül University 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 1 inclusion and 4 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 5 Jan 2024. 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?
Michigan Neuropathy Screening Instrument (time frame: May 2023- November 2023). The study lists 6 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 5 Jan 2024.