Temporomandibular DisorderNCT04495777
Prevalence of Temporomandibular Disorders and Its Association With Oral Parafunctions, Neck Pain and Function
An observational study of Temporomandibular Disorder and Neck Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To determine the prevalence of temporomandibular disorders (TMD) in female healthcare students and to assess its association with oral parafunctions, neck pain and function. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Neck Pain
- What is being tested?
- Fonseca Anamnestic Index
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Jun 2020
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: University students who are currently ongoing their education in healthcare department
Who may be able to join
- be Adnan Menderes University student
- female gender
- express consent to participate voluntarily in the study
Who cannot join
- with recent trauma to head and face,
- history of systematic diseases and neurological disorders
- currently an ongoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Temporomandibular Disorders and Its Association With Oral Parafunctions, Neck Pain and Function in Female Turkish Healthcare Students: A Cross-Sectional Study
Purpose: To determine the prevalence of temporomandibular disorders (TMD) in female healthcare students and to assess its association with oral parafunctions, neck pain and function.
Methods: Female medical students will be included in the study on a voluntary basis using stratified sampling method according to the department they were being educated. The presence and severity of TMD will be assessed with the Fonseca's Anamnestic Index (FAI). The oral parafunctions will be self-reported with the Oral Behavior Checklist (OBC). The neck pain and function will be recorded with the Core Outcome Measure Index (COMI). A Chi-square test and Spearman correlation analysis will used for statistical analysis.
Read the detailed description
Temporomandibular disorder (TMD) has a multifactorial etiology related to parafunctional habits, emotional and psychological factors, trauma, posture, other musculoskeletal, or rheumatic disorders (1). Symptoms of TMD may include temporomandibular joint pain and clicks, headache, myofascial pain, decreased mandibular range of motion, masticatory muscle fatigue, limitation of mouth opening, pain when chewing, tinnitus, neuralgias, and bruxism (1,2). The severity of symptoms is related to the age and gender of the patients. Women showed a higher prevalence of TMD symptoms, with proportions varying from two to six women for each man, usually with ages between 20 and 40 years3. The distribution of age and gender in TMD, suggests a possible link between its pathogenesis and the female sex hormone, the estrogen, or between TMD and the mechanisms of pain modulation, as women show more sensitivity to most of the pain modalities (3,4) Epidemiologic studies showed that TMD prevalence in the students ranges from 50% to 77% (5-7). Several studies reported that a higher prevalence of TMD ranges from 47% to 81% in the Turkish student population (8-13). However, in some cases especially in students, the presence of TMD is asymptomatic. Therefore, the diagnosis of early symptoms and signs of TMD is crucial in preventing or minimizing TMD signs and symptoms (9).
Parafunctional habits such as bruxism, tooth clenching, gum chewing, biting foreign objects, and prolonged nail-biting might increase the risk of developing TMD (14). Even there are several studies examining the association of TMD and oral parafunctions in students (15-17); still, more studies are need to identify which oral behaviors cause TMD patients and healthy populations (18). Therefore, understanding the TMD symptoms in association with the oral parafunctions could provide different perspectives and an efficient treatment program (15).
To our knowledge, there is no study about TMD prevalence in female healthcare students and its association with oral parafunctions, neck pain, and function. The aims of this cross-sectional study were: (1) to evaluate the prevalence of TMD in female healthcare students and (2) to determine the association of TMD severity with oral parafunctional habits, neck pain and function.
- Conditions
- Temporomandibular Disorder, Neck Pain
- Being tested
- Fonseca Anamnestic Index
- Keywords
- temporomandibular, students, prevalence, parafunctional habit, neck pain
- Medical subject headings
- Temporomandibular Joint Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fonseca Anamnestic IndexOther
Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19).
| Study group | Role | What they receive |
|---|---|---|
| students | students were assessed in order to have a risk for TMD in order to their status of having parafunctional habits and neck pain Receives: Other: Fonseca Anamnestic Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fonseca Anamnestic Index
Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19).
Measured: baseline
Secondary outcomes (2)
Oral parafunction
Oral behaviors checklist is a self-report questionnaire for determining the frequency of oral parafunctional behaviors which are any abnormal behavior or functioning of the oral structures and associated muscles in the past one month. Original questionnaire consists of 21items, 2 items for oral behaviors during sleep, and 19 items for oral behaviors during waking hours. In this study the questionnaire was modified and two of the questions were exctracted due to study of Hayek et al25. Each item is scored from 0-4 based on the frequency of activity performed: a score of 0=none of the time; a score of 1=a little of the time; a score of 2=some of the time; a score of 3=most of the time and score of 4=all the time; with a range of 0-76 18.The sum of scoring had the following scheme: none = 0, low = 1-16, and high = 17-76 (20).
Measured: baseline
Neck pain and function
The COMI-neck is a short, self-administered outcome instrument consisting of just seven items to evaluate the five dimensions pain, neck-related function, symptom-specific well-being, general quality of life, and disability (social and work) (21,22). The two pain items use a 0-10 graphic rating scale; all other items use a 5-point adjective scale. For COMI summary score, each of the domain scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status (23).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GulOznur KARABICAK, Aydin Adnan Menderes University
- Investigators
- Gul Oznur KARABICAK, Phd, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495777
- Sponsor's protocol ID
- tmd_101
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedroni CR, De Oliveira AS, Guaratini MI. Prevalence study of signs and symptoms of temporomandibular disorders in university students. J Oral Rehabil. 2003 Mar;30(3):283-9. doi: 10.1046/j.1365-2842.2003.01010.x.
PubMed 12588501Kuc J, Szarejko KD, Sierpinska T. Evaluation of Orofacial and General Pain Location in Patients With Temporomandibular Joint Disorder-Myofascial Pain With Referral. Front Neurol. 2019 May 29;10:546. doi: 10.3389/fneur.2019.00546. eCollection 2019.
PubMed 31191438Schmid-Schwap M, Bristela M, Kundi M, Piehslinger E. Sex-specific differences in patients with temporomandibular disorders. J Orofac Pain. 2013 Winter;27(1):42-50. doi: 10.11607/jop.970.
PubMed 23424719Nekora-Azak A, Evlioglu G, Ceyhan A, Keskin H, Berkman S, Issever H. Estrogen replacement therapy among postmenopausal women and its effects on signs and symptoms of temporomandibular disorders. Cranio. 2008 Jul;26(3):211-5. doi: 10.1179/crn.2008.028.
PubMed 18686498Nomura K, Vitti M, Oliveira AS, Chaves TC, Semprini M, Siessere S, Hallak JE, Regalo SC. Use of the Fonseca's questionnaire to assess the prevalence and severity of temporomandibular disorders in Brazilian dental undergraduates. Braz Dent J. 2007;18(2):163-7. doi: 10.1590/s0103-64402007000200015.
PubMed 17982559Karthik R, Hafila MIF, Saravanan C, Vivek N, Priyadarsini P, Ashwath B. Assessing Prevalence of Temporomandibular Disorders among University Students: A Questionnaire Study. J Int Soc Prev Community Dent. 2017 Jun;7(Suppl 1):S24-S29. doi: 10.4103/jispcd.JISPCD_146_17. Epub 2017 Jun 20.
PubMed 28713764Lung J, Bell L, Heslop M, Cuming S, Ariyawardana A. Prevalence of temporomandibular disorders among a cohort of university undergraduates in Australia. J Investig Clin Dent. 2018 Aug;9(3):e12341. doi: 10.1111/jicd.12341. Epub 2018 Mar 31.
PubMed 29604182Emel Dervis N. Prevalence of Temporomandibular Disorder in Turkish University Students: a Questionnaire Study. Balk J Dent Med. 2019; 23 (2): 80-87 doi:10.2478/bjdm-2019-0015
Türken R, Büyük SK, Yaşa Y. Diş Hekimliği Fakültesi Öğrencilerinde Temporomandibular Eklem Rahatsızlıklarının ve Ağız Sağlığı Alışkanlıklarının Değerlendirilmesi. Acıbadem Üniversitesi Sağlık Bilim Derg. 2020;11(2):208-213. https://doi.org/10.31067/0.2018.83.
Tanhan A, Yıldız A, Demirbüken İ, Polat MG. Sağlık Bilimleri Öğrencilerinde Temporomandibular Eklem Disfonksiyon Riskinin Araştırılması. Sak Med J. 2019. doi:10.31832/smj.490740
Yalcin Yeler D, Yilmaz N, Koraltan M, Aydin E. A survey on the potential relationships between TMD, possible sleep bruxism, unilateral chewing, and occlusal factors in Turkish university students. Cranio. 2017 Sep;35(5):308-314. doi: 10.1080/08869634.2016.1239851. Epub 2016 Oct 6.
PubMed 27707365Ozdinc S PhD, Ata H MSc, Selcuk H MSc, Can HB MSc, Sermenli N MSc, Turan FN PhD. Temporomandibular joint disorder determined by Fonseca anamnestic index and associated factors in 18- to 27-year-old university students. Cranio. 2020 Sep;38(5):327-332. doi: 10.1080/08869634.2018.1513442. Epub 2018 Sep 8.
PubMed 30198391Ayalı A, Ramoğlu S. KUZEY KIBRIS'TA DİŞ HEKİMLİĞİ FAKÜLTESİ ÖĞRENCİLERİNDE TEMPOROMANDİBULER EKLEM DİSFONKSİYONU'NUN PREVALANSI. Atatürk Üniversitesi Diş Hekim Fakültesi Derg. 2015;24(3). doi:10.17567/dfd.91850
Oliveira LK, Almeida Gde A, Lelis ER, Tavares M, Fernandes Neto AJ. Temporomandibular disorder and anxiety, quality of sleep, and quality of life in nursing professionals. Braz Oral Res. 2015;29:S1806-83242015000100265. doi: 10.1590/1807-3107BOR-2015.vol29.0070.
PubMed 26039910Chatzopoulos GS, Sanchez M, Cisneros A, Wolff LF. Prevalence of temporomandibular symptoms and parafunctional habits in a university dental clinic and association with gender, age, and missing teeth. Cranio. 2019 May;37(3):159-167. doi: 10.1080/08869634.2017.1399649. Epub 2017 Nov 16.
PubMed 29143569
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Temporomandibular Disorders and Its Association With Oral Parafunctions, Neck Pain and Function in Female Turkish Healthcare Students: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04495777
- Acronym / sponsor ID
- tmd_101
- Conditions
- Temporomandibular Disorder, Neck Pain
- Keywords
- temporomandibular, students, prevalence, parafunctional habit, neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 3 Aug 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.
Purpose: To determine the prevalence of temporomandibular disorders (TMD) in female healthcare students and to assess its association with oral parafunctions, neck pain and function.
Methods: Female medical students will be included in the study on a voluntary basis using stratified sampling method according to the department they were being educated. The presence and severity of TMD will be assessed with the Fonseca's Anamnestic Index (FAI). The oral parafunctions will be self-reported with the Oral Behavior Checklist (OBC). The neck pain and function will be recorded with the Core Outcome Measure Index (COMI). A Chi-square test and Spearman correlation analysis will used for statistical analysis.
Detailed description
Temporomandibular disorder (TMD) has a multifactorial etiology related to parafunctional habits, emotional and psychological factors, trauma, posture, other musculoskeletal, or rheumatic disorders (1). Symptoms of TMD may include temporomandibular joint pain and clicks, headache, myofascial pain, decreased mandibular range of motion, masticatory muscle fatigue, limitation of mouth opening, pain when chewing, tinnitus, neuralgias, and bruxism (1,2). The severity of symptoms is related to the age and gender of the patients. Women showed a higher prevalence of TMD symptoms, with proportions varying from two to six women for each man, usually with ages between 20 and 40 years3. The distribution of age and gender in TMD, suggests a possible link between its pathogenesis and the female sex hormone, the estrogen, or between TMD and the mechanisms of pain modulation, as women show more sensitivity to most of the pain modalities (3,4) Epidemiologic studies showed that TMD prevalence in the students ranges from 50% to 77% (5-7). Several studies reported that a higher prevalence of TMD ranges from 47% to 81% in the Turkish student population (8-13). However, in some cases especially in students, the presence of TMD is asymptomatic. Therefore, the diagnosis of early symptoms and signs of TMD is crucial in preventing or minimizing TMD signs and symptoms (9).
Parafunctional habits such as bruxism, tooth clenching, gum chewing, biting foreign objects, and prolonged nail-biting might increase the risk of developing TMD (14). Even there are several studies examining the association of TMD and oral parafunctions in students (15-17); still, more studies are need to identify which oral behaviors cause TMD patients and healthy populations (18). Therefore, understanding the TMD symptoms in association with the oral parafunctions could provide different perspectives and an efficient treatment program (15).
To our knowledge, there is no study about TMD prevalence in female healthcare students and its association with oral parafunctions, neck pain, and function. The aims of this cross-sectional study were: (1) to evaluate the prevalence of TMD in female healthcare students and (2) to determine the association of TMD severity with oral parafunctional habits, neck pain and function.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| students | – | Other: Fonseca Anamnestic Indexstudents were assessed in order to have a risk for TMD in order to their status of having parafunctional habits and neck pain |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students who are currently ongoing their education in healthcare department
Key inclusion criteria (3 listed)
- be Adnan Menderes University student
- female gender
- express consent to participate voluntarily in the study
Key exclusion criteria (3 listed)
- with recent trauma to head and face,
- history of systematic diseases and neurological disorders
- currently an ongoing orthodontic treatment
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 |
|---|---|---|
| Fonseca Anamnestic IndexFonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19). | Other | students |
Primary outcome
Fonseca Anamnestic Index
Time frame: baseline
Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19).
2 secondary outcomes
Oral parafunction
Time frame: baseline
Neck pain and function
Time frame: baseline
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 Aug 2022.
- Background: PubMed 12588501Pedroni CR, De Oliveira AS, Guaratini MI. Prevalence study of signs and symptoms of temporomandibular disorders in university students. J Oral Rehabil. 2003 Mar;30(3):283-9. doi: 10.1046/j.1365-2842.2003.01010.x.
- Background: PubMed 31191438Kuc J, Szarejko KD, Sierpinska T. Evaluation of Orofacial and General Pain Location in Patients With Temporomandibular Joint Disorder-Myofascial Pain With Referral. Front Neurol. 2019 May 29;10:546. doi: 10.3389/fneur.2019.00546. eCollection 2019.
- Background: PubMed 23424719Schmid-Schwap M, Bristela M, Kundi M, Piehslinger E. Sex-specific differences in patients with temporomandibular disorders. J Orofac Pain. 2013 Winter;27(1):42-50. doi: 10.11607/jop.970.
- Background: PubMed 18686498Nekora-Azak A, Evlioglu G, Ceyhan A, Keskin H, Berkman S, Issever H. Estrogen replacement therapy among postmenopausal women and its effects on signs and symptoms of temporomandibular disorders. Cranio. 2008 Jul;26(3):211-5. doi: 10.1179/crn.2008.028.
- Background: PubMed 17982559Nomura K, Vitti M, Oliveira AS, Chaves TC, Semprini M, Siessere S, Hallak JE, Regalo SC. Use of the Fonseca's questionnaire to assess the prevalence and severity of temporomandibular disorders in Brazilian dental undergraduates. Braz Dent J. 2007;18(2):163-7. doi: 10.1590/s0103-64402007000200015.
- Background: PubMed 28713764Karthik R, Hafila MIF, Saravanan C, Vivek N, Priyadarsini P, Ashwath B. Assessing Prevalence of Temporomandibular Disorders among University Students: A Questionnaire Study. J Int Soc Prev Community Dent. 2017 Jun;7(Suppl 1):S24-S29. doi: 10.4103/jispcd.JISPCD_146_17. Epub 2017 Jun 20.
- Background: PubMed 29604182Lung J, Bell L, Heslop M, Cuming S, Ariyawardana A. Prevalence of temporomandibular disorders among a cohort of university undergraduates in Australia. J Investig Clin Dent. 2018 Aug;9(3):e12341. doi: 10.1111/jicd.12341. Epub 2018 Mar 31.
- BackgroundEmel Dervis N. Prevalence of Temporomandibular Disorder in Turkish University Students: a Questionnaire Study. Balk J Dent Med. 2019; 23 (2): 80-87 doi:10.2478/bjdm-2019-0015
- BackgroundTürken R, Büyük SK, Yaşa Y. Diş Hekimliği Fakültesi Öğrencilerinde Temporomandibular Eklem Rahatsızlıklarının ve Ağız Sağlığı Alışkanlıklarının Değerlendirilmesi. Acıbadem Üniversitesi Sağlık Bilim Derg. 2020;11(2):208-213. https://doi.org/10.31067/0.2018.83.
- BackgroundTanhan A, Yıldız A, Demirbüken İ, Polat MG. Sağlık Bilimleri Öğrencilerinde Temporomandibular Eklem Disfonksiyon Riskinin Araştırılması. Sak Med J. 2019. doi:10.31832/smj.490740
- Background: PubMed 27707365Yalcin Yeler D, Yilmaz N, Koraltan M, Aydin E. A survey on the potential relationships between TMD, possible sleep bruxism, unilateral chewing, and occlusal factors in Turkish university students. Cranio. 2017 Sep;35(5):308-314. doi: 10.1080/08869634.2016.1239851. Epub 2016 Oct 6.
- Background: PubMed 30198391Ozdinc S PhD, Ata H MSc, Selcuk H MSc, Can HB MSc, Sermenli N MSc, Turan FN PhD. Temporomandibular joint disorder determined by Fonseca anamnestic index and associated factors in 18- to 27-year-old university students. Cranio. 2020 Sep;38(5):327-332. doi: 10.1080/08869634.2018.1513442. Epub 2018 Sep 8.
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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.
Gul Oznur KARABICAK, Phd principal investigator
Aydin Adnan Menderes University
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 Temporomandibular Disorder and Neck Pain, run by Aydin Adnan Menderes 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 3 inclusion and 3 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 Aug 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 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?
Fonseca Anamnestic Index (time frame: baseline). 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 NCT04495777, which also lists 23 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 19 Aug 2022.