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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04138550
Other study ID # PUB 1114003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date December 2024

Study information

Verified date March 2024
Source Misr International University
Contact Khaled M. Keraa, Dr
Phone (+20)1005048718
Email khaled.koraa@miuegypt.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psycho-social social support are potential risk factors for morbidity and premature death. Despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups.The study aims To identify the potential social determinants with an influence on oral health status of Egyptian women.


Description:

Statement of problem Globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psychosocial social support are potential risk factors for morbidity and premature death. Despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups. Aim of study To identify the potential social determinants with an influence on oral health status of Egyptian women. Materials and methods A total of 300 Egyptian women in childbearing age (18-49 years) will be recruited from 4 Primary healthcare units in Qalyubia governorate in Egypt. Four trained investigators will conduct a face-to face interview with study participants to gather data on potential structural and intermediary social determinants of health using a questionnaire. The questionnaire is based upon The Commission on Social Determinants of Health (CSDH) conceptual framework which was set up by the World Health Organization in 2005. This tool includes questions on socioeconomic position, material factors and living conditions, psychosocial factors and behavioral factors. Caries experience and gingival health of participants will be determined using DMFT, DMFS and CPITN indices respectively.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units. Exclusion Criteria: - Women who recently moved from one place of residence to another. - Women attending the dental clinic at one of the primary health units selected for the survey. - Pregnant Women. - Completely Edentulous Women. - Women with mental or psychological issues.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Misr International University

References & Publications (14)

Acharya DR, Bell JS, Simkhada P, van Teijlingen ER, Regmi PR. Women's autonomy in household decision-making: a demographic study in Nepal. Reprod Health. 2010 Jul 15;7:15. doi: 10.1186/1742-4755-7-15. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Dahlem NW, Zimet GD, Walker RR. The Multidimensional Scale of Perceived Social Support: a confirmation study. J Clin Psychol. 1991 Nov;47(6):756-61. doi: 10.1002/1097-4679(199111)47:63.0.co;2-l. — View Citation

Daly MC, Duncan GJ, McDonough P, Williams DR. Optimal indicators of socioeconomic status for health research. Am J Public Health. 2002 Jul;92(7):1151-7. doi: 10.2105/ajph.92.7.1151. Erratum In: Am J Public Health 2002 Aug;92(8):1212. — View Citation

Fatima A. Al-Ghadban. Evaluating the Face Validity of an Arabic-language Translation of a Food Security Questionnaire in Arabic-speaking Populations. THESIS 2012.

Frieden TR. A framework for public health action: the health impact pyramid. Am J Public Health. 2010 Apr;100(4):590-5. doi: 10.2105/AJPH.2009.185652. Epub 2010 Feb 18. — View Citation

GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Kwan S, Petersen PE. Oral health: equity and social determinants. In: Blas E, Sivansankara Kurup A, editors. Equity, social determinants and public health programmes. Geneva: World Health Organization, 2010; 159-76.

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442. — View Citation

Melki IS, Beydoun HA, Khogali M, Tamim H, Yunis KA; National Collaborative Perinatal Neonatal Network (NCPNN). Household crowding index: a correlate of socioeconomic status and inter-pregnancy spacing in an urban setting. J Epidemiol Community Health. 2004 Jun;58(6):476-80. doi: 10.1136/jech.2003.012690. — View Citation

Sanders AE 2007. Social Determinants of Oral Health: conditions linked to socioeconomic inequalities in oral health and in the Australian population. AIHW cat. no. POH 7. Canberra: Australian Institute of Health and Welfare (Population Oral Health Series No. 7).

Smith MS, Wallston KA, Smith CA. The development and validation of the Perceived Health Competence Scale. Health Educ Res. 1995 Mar;10(1):51-64. doi: 10.1093/her/10.1.51. — View Citation

Steele J, Shen J, Tsakos G, Fuller E, Morris S, Watt R, Guarnizo-Herreno C, Wildman J. The Interplay between socioeconomic inequalities and clinical oral health. J Dent Res. 2015 Jan;94(1):19-26. doi: 10.1177/0022034514553978. Epub 2014 Oct 24. — View Citation

World Health Organization. A Conceptual Framework for Action on the Social Determinants of Health. 2010.

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Social determinants Questionnaire Likert scale 1 - 5 11 months from enrollment
Secondary Caries Experience Decayed, Missed, Filled caries index: 0 - 32 11 months from enrollment
Secondary Gingival/periodontal health Modified Community Periodontal Index: 0 - 4 11 months from enrollment
Secondary Esthetics Number of unfilled upper spaces 11 months from enrollment
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