Anxiety DisordersNCT04274855
Effect of Trait Anxiety in Women on Oral Health Status and Oral Health Care-Seeking Behavior
An observational study of Anxiety Disorders and Oral Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
Trait anxiety is the tendency of an individual to perceive environmental stimuli such as different events and situations as threatening; it's stable and reflects how an individual generally feels. In 2015, it was estimated that 3.6% of the population lived with anxiety disorders globally, i.e. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Oral Disease, Periodontal Diseases
- How many people
- 451 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2020to 30 Dec 2021
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A convenient sample of Egyptian women attending Faculty of Dentistry, Ain Shams University for reasons other than seeking dental treatment (e.g. accompanying other patients) will be recruited and enrolled in the study.
Who may be able to join
- Egyptian women
- Age range: From late adolescence to early elderly (20-55 years of age)
Who cannot join
- Women who do not consent to participate in the study.
- Women who have any diagnosed medical disorders that directly affect their oral health (e.g. Diabetes).
- Women with any diagnosed mental disorders. (Due to the increased incidence of dental caries and gingival disease in addition to the side effects of psychotropic drugs).
- Pregnant women. (Due to the affection of gingival and periodontal condition).
- Women seeking dental treatment.(Otherwise, oral health care-seeking behavior will be biased).
- Their number will be reported by a flow chart.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Ain Shams University
Cairo
Mariam Sharaf, Masters, +2 01068022877, mariamayman@dent.asu.edu.eg
About this study
Official title: Effect of Trait Anxiety in Women on Oral Health Status and Oral Health Care-Seeking Behavior: A Cross-Sectional Study
Trait anxiety is the tendency of an individual to perceive environmental stimuli such as different events and situations as threatening; it's stable and reflects how an individual generally feels.
In 2015, it was estimated that 3.6% of the population lived with anxiety disorders globally, i.e. approximately 264 million people lived with anxiety disorders worldwide of which 31.36 million resided in the Eastern Mediterranean region, that's to say, 10% of the global number of anxiety cases. Moreover, females were more affected than males in a proportion of 4.6% as opposed to 2.6% respectively. The prevalence of anxiety has increased by 14.9% from 2005 to 2015. In addition, in 2017, approximately 42 million new cases were recorded globally.
Read more
In Egypt, the total number of anxiety cases were more than 3 million in 2015 thus indicating that 4.2% of the total population lived with anxiety.
Anxiety may affect the individual's utilization of dental services and predispose to a delay in seeking dental treatment and thus might compromise the overall oral health.
Accordingly, this study aims to investigate the effect of trait anxiety on the oral health status of women and determine their behavior towards the utilization of dental services.
To our knowledge, no previous research has been conducted to assess such relationship in Egypt.
Read the detailed description
Trait anxiety is a major risk factor for developing anxiety disorders and major depressive disorder, all sharing the same genetic and environmental etiological factors. Another hypothesis is that the etiological factors predispose first to the occurrence of trait anxiety which afterwards, develops into anxiety disorders and clinical depression. Based on this, it's of great importance to be attentive to trait anxiety in clinical practice and research. It's also important to investigate how trait anxiety leads to poorer health outcomes in order to lower its burden and consequences.
Years lived with disability (YLD) is one component that assists in measuring the burden of disease. YLD is the number of years that a person lives with disease. Globally, 24.6 million years lived with disability was due to anxiety disorders. 354 YLD per 100,000 populations were recorded in the Eastern Mediterranean region. Moreover, anxiety ranked the seventh cause of YLD in the Eastern Mediterranean region.
Oral disorders (e.g. periodontal disease and dental caries) collectively have been the most prevalent conditions from 1990 to 2017. Globally, 3.4 billion people lived with oral disorders in 2017.
Bruxism by definition is an activity that involves clenching and grinding of the teeth during sleep(nocturnal bruxism) or when awake(diurnal bruxism). Dentists regard bruxism as a major issue due to its consequences, which range from the destruction of the tooth structure and dental restorations to tempro-mandibular joint (TMJ) manifestations as well as temporal headaches reported by the patients. Psychological disorders such as stress and anxiety are risk factors for the development of bruxism in individuals. Results from previous studies on the relationship between anxiety and bruxism were contradictory; while some studies reported an association between anxiety in different age groups and bruxism, other studies denied such relationship. It's important to study the association between common mental disorders and the occurrence of bruxism activity.
High frequency of sugar consumption in food and beverages has been linked to several common mental disorders. Individuals with mood disorders usually follow a diet that has high amounts of sugar and fats and low amount of fibers. Dental caries is majorly dependent on the frequency of sugar intake, in addition to its form and amount. Therefore individuals with common mental disorders are at an increased risk of developing 'rampant caries'. Rampant caries by definition is a progressive and rapidly appearing dental caries with acute onset, which leads to early pulp involvement, and affects a large number of erupted teeth. Therefore it is of great importance for dental practitioners not only to treat the disease outcome, but also to identify the different phases of the disease. According to this, assessing the risk of developing dental caries in mentally vulnerable patients has been of great importance to tailor a preventive approach specially designed for each patient.
Study procedures:
- A comprehensive literature review was conducted using electronic databases to identify relevant tools (questionnaires and clinical examination tools) to be used in the present study.
- Data about socio-demographic characteristics, severity of trait anxiety(assessed by Egyptian version of State-Trait Anxiety Inventory (STAI Y2 form), presence of bruxism activity, self-perceived dental health status and oral health care-seeking behavior will be collected by means of questionnaires.
- Clinical examination to assess periodontal health condition and caries risk assessment will be conducted.
- All data, as well as, clinical examination will be conducted via one well-trained investigator.
- Conditions
- Anxiety Disorders, Oral Disease, Periodontal Diseases, Periodontal Attachment Loss, Periodontal Pocket, Periodontal Inflammation
- Keywords
- Trait anxiety, Oral health, Oral health status, Oral health outcomes, Periodontal, Gingival, Caries risk assessment, Bruxism, Healthcare utilization, Health care-seeking behavior, Perceived oral health
- Medical subject headings
- Anxiety Disorders, Mouth Diseases, Periodontal Diseases, Periodontal Attachment Loss, Periodontal Pocket, Gingival Recession, Gingival Hemorrhage, Gingival Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of gingival and periodontal disease
Community Periodontal Index(CPI) on a scale that ranges from 0 to 4, where 0 indicates healthy gingival condition and 4 indicates unhealthy gingival condition (periodontitis)
Measured: February 2020-November 2020
Risk of developing dental caries
American Dental Association (ADA) caries risk assessment tool adult form
Measured: February 2020-November 2020
Reports of bruxism activity
Self-reported questionnaire which includes six questions with good content and face validity to assess bruxism activity on a 4-point Likert scale.
This questionnaire was translated into Arabic language in the current study. This questionnaire is conducted in the form of an interview.
Measured: February 2020-November 2020
Secondary outcomes (2)
Oral health care-seeking behavior
Five self-reported English questions adopted from previous studies for the same purpose. Those questions were translated into Arabic language in the current study.
This questionnaire is conducted in the form of an interview.
Measured: February 2020-December 2020
Self-perceived dental health status
Participants are asked to rate their dental health status on 6-point scale from 'excellent' to 'very poor'.
Measured: February 2020-December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start5 Feb 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 451 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ayman Amin Sharaf, Ain Shams University
- Investigators
- Mariam Sharaf, Masters, Principal investigator, Ain Shams UniversityAmira Badran, PhD, Study director, Ain Shams UniversityReham Abou ElFadl, PhD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274855
- Sponsor's protocol ID
- 830
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Kesim S, Unalan D, Esen C, Ozturk A. The relationship between periodontal disease severity and state-trait anxiety level. J Pak Med Assoc. 2012 Dec;62(12):1304-8.
PubMed 23866479Kisely S, Sawyer E, Siskind D, Lalloo R. The oral health of people with anxiety and depressive disorders - a systematic review and meta-analysis. J Affect Disord. 2016 Aug;200:119-32. doi: 10.1016/j.jad.2016.04.040. Epub 2016 Apr 21.
PubMed 27130961Sandi C, Richter-Levin G. From high anxiety trait to depression: a neurocognitive hypothesis. Trends Neurosci. 2009 Jun;32(6):312-20. doi: 10.1016/j.tins.2009.02.004. Epub 2009 May 4.
PubMed 19409624Winocur E, Uziel N, Lisha T, Goldsmith C, Eli I. Self-reported bruxism - associations with perceived stress, motivation for control, dental anxiety and gagging. J Oral Rehabil. 2011 Jan;38(1):3-11. doi: 10.1111/j.1365-2842.2010.02118.x.
PubMed 20557433Restrepo CC, Vasquez LM, Alvarez M, Valencia I. Personality traits and temporomandibular disorders in a group of children with bruxing behaviour. J Oral Rehabil. 2008 Aug;35(8):585-93. doi: 10.1111/j.1365-2842.2007.01838.x. Epub 2008 Apr 15.
PubMed 18422509Parish CL, Feaster DJ, Pereyra MR, Alcaide M, Cohen M, Levin S, Gustafson D, Merenstein D, Aouizerat B, Donohue J, Webster-Cyriaque J, Wingood G, Kempf M, Metsch LR. Dental insurance, dental care utilization, and perceived unmet dental needs in women living with HIV: Results from the Women's Interagency HIV Study. J Public Health Dent. 2019 Dec;79(4):343-351. doi: 10.1111/jphd.12336. Epub 2019 Aug 16.
PubMed 31418877Ainamo J, Barmes D, Beagrie G, Cutress T, Martin J, Sardo-Infirri J. Development of the World Health Organization (WHO) community periodontal index of treatment needs (CPITN). Int Dent J. 1982 Sep;32(3):281-91. No abstract available.
PubMed 6958657
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trait Anxiety in Women on Oral Health Status and Oral Health Care-Seeking Behavior: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04274855
- Acronym / sponsor ID
- 830
- Conditions
- Anxiety Disorders, Oral Disease, Periodontal Diseases, Periodontal Attachment Loss, Periodontal Pocket, Periodontal Inflammation
- Keywords
- Trait anxiety, Oral health, Oral health status, Oral health outcomes, Periodontal, Gingival, Caries risk assessment, Bruxism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 451 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Feb 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.
Trait anxiety is the tendency of an individual to perceive environmental stimuli such as different events and situations as threatening; it's stable and reflects how an individual generally feels.
In 2015, it was estimated that 3.6% of the population lived with anxiety disorders globally, i.e. approximately 264 million people lived with anxiety disorders worldwide of which 31.36 million resided in the Eastern Mediterranean region, that's to say, 10% of the global number of anxiety cases. Moreover, females were more affected than males in a proportion of 4.6% as opposed to 2.6% respectively. The prevalence of anxiety has increased by 14.9% from 2005 to 2015. In addition, in 2017, approximately 42 million new cases were recorded globally.
In Egypt, the total number of anxiety cases were more than 3 million in 2015 thus indicating that 4.2% of the total population lived with anxiety.
Anxiety may affect the individual's utilization of dental services and predispose to a delay in seeking dental treatment and thus might compromise the overall oral health.
Accordingly, this study aims to investigate the effect of trait anxiety on the oral health status of women and determine their behavior towards the utilization of dental services.
To our knowledge, no previous research has been conducted to assess such relationship in Egypt.
Detailed description
Trait anxiety is a major risk factor for developing anxiety disorders and major depressive disorder, all sharing the same genetic and environmental etiological factors. Another hypothesis is that the etiological factors predispose first to the occurrence of trait anxiety which afterwards, develops into anxiety disorders and clinical depression. Based on this, it's of great importance to be attentive to trait anxiety in clinical practice and research. It's also important to investigate how trait anxiety leads to poorer health outcomes in order to lower its burden and consequences.
Years lived with disability (YLD) is one component that assists in measuring the burden of disease. YLD is the number of years that a person lives with disease. Globally, 24.6 million years lived with disability was due to anxiety disorders. 354 YLD per 100,000 populations were recorded in the Eastern Mediterranean region. Moreover, anxiety ranked the seventh cause of YLD in the Eastern Mediterranean region.
Oral disorders (e.g. periodontal disease and dental caries) collectively have been the most prevalent conditions from 1990 to 2017. Globally, 3.4 billion people lived with oral disorders in 2017.
Bruxism by definition is an activity that involves clenching and grinding of the teeth during sleep(nocturnal bruxism) or when awake(diurnal bruxism). Dentists regard bruxism as a major issue due to its consequences, which range from the destruction of the tooth structure and dental restorations to tempro-mandibular joint (TMJ) manifestations as well as temporal headaches reported by the patients. Psychological disorders such as stress and anxiety are risk factors for the development of bruxism in individuals. Results from previous studies on the relationship between anxiety and bruxism were contradictory; while some studies reported an association between anxiety in different age groups and bruxism, other studies denied such relationship. It's important to study the association between common mental disorders and the occurrence of bruxism activity.
High frequency of sugar consumption in food and beverages has been linked to several common mental disorders. Individuals with mood disorders usually follow a diet that has high amounts of sugar and fats and low amount of fibers. Dental caries is majorly dependent on the frequency of sugar intake, in addition to its form and amount. Therefore individuals with common mental disorders are at an increased risk of developing 'rampant caries'. Rampant caries by definition is a progressive and rapidly appearing dental caries with acute onset, which leads to early pulp involvement, and affects a large number of erupted teeth. Therefore it is of great importance for dental practitioners not only to treat the disease outcome, but also to identify the different phases of the disease. According to this, assessing the risk of developing dental caries in mentally vulnerable patients has been of great importance to tailor a preventive approach specially designed for each patient.
Study procedures:
- A comprehensive literature review was conducted using electronic databases to identify relevant tools (questionnaires and clinical examination tools) to be used in the present study.
- Data about socio-demographic characteristics, severity of trait anxiety(assessed by Egyptian version of State-Trait Anxiety Inventory (STAI Y2 form), presence of bruxism activity, self-perceived dental health status and oral health care-seeking behavior will be collected by means of questionnaires.
- Clinical examination to assess periodontal health condition and caries risk assessment will be conducted.
- All data, as well as, clinical examination will be conducted via one well-trained investigator.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A convenient sample of Egyptian women attending Faculty of Dentistry, Ain Shams University for reasons other than seeking dental treatment (e.g. accompanying other patients) will be recruited and enrolled in the study.
Key inclusion criteria (2 listed)
- Egyptian women
- Age range: From late adolescence to early elderly (20-55 years of age)
Key exclusion criteria (6 listed)
- Women who do not consent to participate in the study.
- Women who have any diagnosed medical disorders that directly affect their oral health (e.g. Diabetes).
- Women with any diagnosed mental disorders. (Due to the increased incidence of dental caries and gingival disease in addition to the side effects of psychotropic drugs).
- Pregnant women. (Due to the affection of gingival and periodontal condition).
- Women seeking dental treatment.(Otherwise, oral health care-seeking behavior will be biased).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of gingival and periodontal disease
Time frame: February 2020-November 2020
Community Periodontal Index(CPI) on a scale that ranges from 0 to 4, where 0 indicates healthy gingival condition and 4 indicates unhealthy gingival condition (periodontitis)
Risk of developing dental caries
Time frame: February 2020-November 2020
American Dental Association (ADA) caries risk assessment tool adult form
Reports of bruxism activity
Time frame: February 2020-November 2020
Self-reported questionnaire which includes six questions with good content and face validity to assess bruxism activity on a 4-point Likert scale. This questionnaire was translated into Arabic language in the current study. This questionnaire is conducted in the form of an interview.
2 secondary outcomes
Oral health care-seeking behavior
Time frame: February 2020-December 2020
Self-perceived dental health status
Time frame: February 2020-December 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 23866479Kesim S, Unalan D, Esen C, Ozturk A. The relationship between periodontal disease severity and state-trait anxiety level. J Pak Med Assoc. 2012 Dec;62(12):1304-8.
- Background: PubMed 27130961Kisely S, Sawyer E, Siskind D, Lalloo R. The oral health of people with anxiety and depressive disorders - a systematic review and meta-analysis. J Affect Disord. 2016 Aug;200:119-32. doi: 10.1016/j.jad.2016.04.040. Epub 2016 Apr 21.
- Background: PubMed 19409624Sandi C, Richter-Levin G. From high anxiety trait to depression: a neurocognitive hypothesis. Trends Neurosci. 2009 Jun;32(6):312-20. doi: 10.1016/j.tins.2009.02.004. Epub 2009 May 4.
- Background: PubMed 20557433Winocur E, Uziel N, Lisha T, Goldsmith C, Eli I. Self-reported bruxism - associations with perceived stress, motivation for control, dental anxiety and gagging. J Oral Rehabil. 2011 Jan;38(1):3-11. doi: 10.1111/j.1365-2842.2010.02118.x.
- Background: PubMed 18422509Restrepo CC, Vasquez LM, Alvarez M, Valencia I. Personality traits and temporomandibular disorders in a group of children with bruxing behaviour. J Oral Rehabil. 2008 Aug;35(8):585-93. doi: 10.1111/j.1365-2842.2007.01838.x. Epub 2008 Apr 15.
- Background: PubMed 31418877Parish CL, Feaster DJ, Pereyra MR, Alcaide M, Cohen M, Levin S, Gustafson D, Merenstein D, Aouizerat B, Donohue J, Webster-Cyriaque J, Wingood G, Kempf M, Metsch LR. Dental insurance, dental care utilization, and perceived unmet dental needs in women living with HIV: Results from the Women's Interagency HIV Study. J Public Health Dent. 2019 Dec;79(4):343-351. doi: 10.1111/jphd.12336. Epub 2019 Aug 16.
- Background: PubMed 6958657Ainamo J, Barmes D, Beagrie G, Cutress T, Martin J, Sardo-Infirri J. Development of the World Health Organization (WHO) community periodontal index of treatment needs (CPITN). Int Dent J. 1982 Sep;32(3):281-91. No abstract available.
- 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.
Mariam Sharaf, Masters principal investigator
Ain Shams University
Amira Badran, PhD study director
Ain Shams University
Reham Abou ElFadl, PhD study director
Ain Shams 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 Anxiety Disorders and Oral Disease, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 6 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 26 Mar 2021. 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 Egypt. 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 Mariam Sharaf, Masters (+2 01068022877, mariamayman@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of gingival and periodontal disease (time frame: February 2020-November 2020). 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?
On the ClinicalTrials.gov record for NCT04274855, which also lists 8 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 26 Mar 2021.