Effect of Trait Anxiety in Women on Oral Health Status and Oral Health Care-Seeking Behavior

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04274855
Collaborator
(none)
451
Enrollment
1
Location
22.8
Anticipated Duration (Months)
19.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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

Study Type:
Observational
Anticipated Enrollment :
451 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Effect of Trait Anxiety in Women on Oral Health Status and Oral Health Care-Seeking Behavior: A Cross-Sectional Study
Actual Study Start Date :
Feb 5, 2020
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Presence of gingival and periodontal disease [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)

  2. Risk of developing dental caries [February 2020-November 2020]

    American Dental Association (ADA) caries risk assessment tool adult form

  3. Reports of bruxism activity [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.

Secondary Outcome Measures

  1. Oral health care-seeking behavior [February 2020-December 2020]

    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.

  2. Self-perceived dental health status [February 2020-December 2020]

    Participants are asked to rate their dental health status on 6-point scale from 'excellent' to 'very poor'.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Egyptian women

  • Age range: From late adolescence to early elderly (20-55 years of age)

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Faculty of Dentistry, Ain Shams UniversityCairoEgypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: Mariam Sharaf, Masters, Ain Shams University
  • Study Director: Amira Badran, PhD, Ain Shams University
  • Study Director: Reham Abou ElFadl, PhD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mariam Ayman Amin Sharaf, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04274855
Other Study ID Numbers:
  • 830
First Posted:
Feb 18, 2020
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mariam Ayman Amin Sharaf, Principal investigator, Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2021