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Oral HealthNCT04148300

The Impact of Oral Health Literacy on Dental Anxiety and Utilization of Oral Health Services

An observational study of Oral Health, run by Misr International University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Oral Health Literacy is an integral part that should be taken into measures when evaluating the oral health status of any population. It has been stated that adults with low oral health literacy are more prone to miss their dental appointments and that low levels of oral health literacy, and being anxious and fearful… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Oral Health
How many people
550 participants
Where
1 siteEgypt
Study dates
1 Feb 2019to 20 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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Dental patients of both gender, aged from 18-60 years old, who can read.

Who may be able to join

  • Both genders.
  • Age: 18 - 60 years old.
  • Dentate or partially edentulous patients with or without fixed or removable appliances.
  • Healthy adults as well as adults with any chronic condition and/or under regular use of medication.

Who cannot join

  • Subjects with mental or psychological problems.
  • Subjects who cannot read or write.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Oral & Dental Medicine

    Cairo

Other trials in Egypt

About this study

Official title: The Impact of Oral Health Literacy on Dental Anxiety and Utilization of Oral Health Services Among Dental Patients: A Cross Sectional Study

Oral Health Literacy is an integral part that should be taken into measures when evaluating the oral health status of any population. It has been stated that adults with low oral health literacy are more prone to miss their dental appointments and that low levels of oral health literacy, and being anxious and fearful of the dentist is a common barrier to the utilization of dental services. Unfortunately no previous studies assessed the oral health literacy level, dental anxiety and utilization of dental services among the Egyptian population. So the aim of the current study is to detect the impact of oral health literacy on level of dental anxiety and utilization of dental services among Misr International University (MIU) dental patients.

Read the detailed description

The current study is a cross sectional study that includes an interview lead questionnaire that will be carried out by second year dental students of the academic years (2018-2019, 2019- 2020). The questionnaire consists of four sections; a demographic section, a modified Arabic Rapid Estimate of Adult Literacy (ARELAD-30) Tool, Arabic Modified Dental Anxiety Scale (AMDAS), and Utilization of oral health services questionnaire. Before conducting the study, orientation sessions and thorough training of the students will be performed to ensure that the students can conduct the interview consistently and efficiently. Students will be asked to design educational materials (brochures, leaflets and posters) that aim at improving patients' knowledge and awareness regarding oral health and the utilization of oral health services. The aim of this study is to detect the impact of oral health literacy on the level of dental anxiety and utilization of dental services among dental patients.

Conditions
Oral Health
Keywords
Oral health literacy, Dental anxiety, Utilization of oral health services, Dental patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of Oral Health Literacy

    modified version of the Arabic Version of Rapid Estimate of Adult Literacy in Medicine (AREALD-30): grades 0 (Complete illiteracy)-30 (Complete literacy)

    Measured: 14 months from the first enrollment

Secondary outcomes (2)

  1. Level of Dental Anxiety

    Arabic Modified Dental Anxiety Scale (AMDAS): Likert scale 1(Extreme anxiety) -5 (Not anxious at all)

    Measured: 14 months from the first enrollment

  2. Level of utilization of oral health services

    Questionnaire: Nominal outcome (%)

    Measured: 14 months from the first enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Dec 2021
  4. Study completion20 Dec 2021

Resources

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
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148300
Sponsor's protocol ID
PUB2121002
Status last verified
Oct 2020
First submitted
30 Oct 2019
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Guo Y, Logan HL, Dodd VJ, Muller KE, Marks JG, Riley JL 3rd. Health literacy: a pathway to better oral health. Am J Public Health. 2014 Jul;104(7):e85-91. doi: 10.2105/AJPH.2014.301930. Epub 2014 May 15.

    PubMed 24832423

  • Batista MJ, Lawrence HP, Sousa MDLR. Oral health literacy and oral health outcomes in an adult population in Brazil. BMC Public Health. 2017 Jul 26;18(1):60. doi: 10.1186/s12889-017-4443-0.

    PubMed 28747157

  • Bahammam MA, Hassan MH. Validity and reliability of an Arabic version of the modified dental anxiety scale in Saudi adults. Saudi Med J. 2014 Nov;35(11):1384-9.

    PubMed 25399217

  • Saatchi M, Abtahi M, Mohammadi G, Mirdamadi M, Binandeh ES. The prevalence of dental anxiety and fear in patients referred to Isfahan Dental School, Iran. Dent Res J (Isfahan). 2015 May-Jun;12(3):248-53.

    PubMed 26005465

  • Fayad MI, Elbieh A, Baig MN, Alruwaili SA. Prevalence of Dental Anxiety among Dental Patients in Saudi Arabia. J Int Soc Prev Community Dent. 2017 Mar-Apr;7(2):100-104. doi: 10.4103/jispcd.JISPCD_19_17. Epub 2017 Mar 29.

    PubMed 28462178

  • Tadakamadla SK, Quadri MF, Pakpour AH, Zailai AM, Sayed ME, Mashyakhy M, Inamdar AS, Tadakamadla J. Reliability and validity of Arabic Rapid Estimate of Adult Literacy in Dentistry (AREALD-30) in Saudi Arabia. BMC Oral Health. 2014 Sep 29;14:120. doi: 10.1186/1472-6831-14-120.

    PubMed 25267119

  • Bommireddy VS, Koka KM, Pachava S, Sanikommu S, Ravoori S, Chandu VC. Dental Service Utilization: Patterns and Barriers among Rural Elderly in Guntur District, Andhra Pradesh. J Clin Diagn Res. 2016 Mar;10(3):ZC43-7. doi: 10.7860/JCDR/2016/17834.7456. Epub 2016 Mar 1.

    PubMed 27135000

  • Crego A, Carrillo-Diaz M, Armfield JM, Romero M. From public mental health to community oral health: the impact of dental anxiety and fear on dental status. Front Public Health. 2014 Feb 28;2:16. doi: 10.3389/fpubh.2014.00016. eCollection 2014.

    PubMed 24616889

  • Burgette JM, Lee JY, Baker AD, Vann WF Jr. Is Dental Utilization Associated with Oral Health Literacy? J Dent Res. 2016 Feb;95(2):160-6. doi: 10.1177/0022034515617457. Epub 2015 Nov 13.

    PubMed 26567035

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Health, run by Misr International 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 4 inclusion and 2 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 22 Oct 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 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?

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?

Level of Oral Health Literacy (time frame: 14 months from the first enrollment). 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 NCT04148300, which also lists 9 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 22 Oct 2024.

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