Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-02 @ 8:27 AM
Study NCT ID:
NCT04138550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social determinants', 'timeFrame': '11 months from enrollment', 'description': 'Questionnaire Likert scale 1 - 5'}], 'secondaryOutcomes': [{'measure': 'Caries Experience', 'timeFrame': '11 months from enrollment', 'description': 'Decayed, Missed, Filled caries index: 0 - 32'}, {'measure': 'Gingival/periodontal health', 'timeFrame': '11 months from enrollment', 'description': 'Modified Community Periodontal Index: 0 - 4'}, {'measure': 'Esthetics', 'timeFrame': '11 months from enrollment', 'description': 'Number of unfilled upper spaces'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social determinants', 'Oral health', 'Women', 'Egypt'], 'conditions': ['Oral Health']}, 'referencesModule': {'references': [{'pmid': '17132052', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20167880', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '27733282', 'type': 'BACKGROUND', '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.'}, {'pmid': '25344336', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. A Conceptual Framework for Action on the Social Determinants of Health. 2010.'}, {'pmid': '12084700', 'type': 'BACKGROUND', '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.'}, {'pmid': '15143115', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '1757578', 'type': 'BACKGROUND', '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.'}, {'pmid': '10150421', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20630107', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '6668417', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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).'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Statement of problem\n\nGlobally, 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.\n\nAim of study\n\nTo identify the potential social determinants with an influence on oral health status of Egyptian women.\n\nMaterials and methods\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units selected for the survey.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units.\n\nExclusion Criteria:\n\n* Women who recently moved from one place of residence to another.\n* Women attending the dental clinic at one of the primary health units selected for the survey.\n* Pregnant Women.\n* Completely Edentulous Women.\n* Women with mental or psychological issues.'}, 'identificationModule': {'nctId': 'NCT04138550', 'briefTitle': 'Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'Exploring the Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'PUB 1114003'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Khaled M. Keraa, Dr', 'role': 'CONTACT', 'email': 'khaled.koraa@miuegypt.edu.eg', 'phone': '(+20)1005048718'}, {'name': 'Reham K. Abou El Fadl, Dr', 'role': 'CONTACT', 'email': 'reham.k.abouelfadl@gmail.com', 'phone': '(+20)1005441171'}], 'overallOfficials': [{'name': 'Mahassen M. Farghaly, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MIU Vice President for Community Services and Environmental Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}