NCT04274855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

February 16, 2020

Last Update Submit

March 24, 2021

Conditions

Keywords

Trait anxietyOral healthOral health statusOral health outcomesPeriodontalGingivalCaries risk assessmentBruxismHealthcare utilizationHealth care-seeking behaviorPerceived oral health

Outcome Measures

Primary Outcomes (3)

  • 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)

    February 2020-November 2020

  • Risk of developing dental caries

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

    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.

    February 2020-November 2020

Secondary Outcomes (2)

  • Oral health care-seeking behavior

    February 2020-December 2020

  • Self-perceived dental health status

    February 2020-December 2020

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (8)

  • 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.

    PMID: 30496104BACKGROUND
  • Kesim 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.

    PMID: 23866479BACKGROUND
  • Kisely 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.

    PMID: 27130961BACKGROUND
  • Sandi 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.

    PMID: 19409624BACKGROUND
  • Winocur 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.

    PMID: 20557433BACKGROUND
  • Restrepo 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.

    PMID: 18422509BACKGROUND
  • Parish 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.

    PMID: 31418877BACKGROUND
  • Ainamo 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.

    PMID: 6958657BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersMouth DiseasesPeriodontal DiseasesPeriodontal Attachment LossPeriodontal PocketGingival RecessionGingival HemorrhageGingival DiseasesBruxismDental CariesPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Mental DisordersStomatognathic DiseasesPeriodontal AtrophyPeriodontitisOral HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsTooth DiseasesHabitsBehaviorTooth DemineralizationTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Mariam Sharaf, Masters

    Ain Shams University

    PRINCIPAL INVESTIGATOR
  • Amira Badran, PhD

    Ain Shams University

    STUDY DIRECTOR
  • Reham Abou ElFadl, PhD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Mariam Sharaf, Masters

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

February 5, 2020

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations