Oral HealthNCT04138550
Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women
An observational study of Oral Health, run by Misr International University.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Oral Health
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2027to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units selected for the survey.
Who may be able to join
- Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring the Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women: A Cross-Sectional Study
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.
Read the detailed 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.
- Conditions
- Oral Health
- Keywords
- Social determinants, Oral health, Women, Egypt
What is being measured
The primary outcome is the main question the study is designed to answer.
Social determinants
Questionnaire Likert scale 1 - 5
Measured: 11 months from enrollment
Secondary outcomes (3)
Caries Experience
Decayed, Missed, Filled caries index: 0 - 32
Measured: 11 months from enrollment
Gingival/periodontal health
Modified Community Periodontal Index: 0 - 4
Measured: 11 months from enrollment
Esthetics
Number of unfilled upper spaces
Measured: 11 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Dec 2027 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahassen M. Farghaly, Professor, Study director, MIU Vice President for Community Services and Environmental Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138550
- Sponsor's protocol ID
- PUB 1114003
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17132052Frieden 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.
PubMed 20167880Kwan 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.
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.
PubMed 27733282Steele 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.
PubMed 25344336World Health Organization. A Conceptual Framework for Action on the Social Determinants of Health. 2010.
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.
PubMed 12084700Melki 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.
PubMed 15143115Fatima A. Al-Ghadban. Evaluating the Face Validity of an Arabic-language Translation of a Food Security Questionnaire in Arabic-speaking Populations. THESIS 2012.
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.
PubMed 1757578Smith 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.
PubMed 10150421Acharya 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.
PubMed 20630107Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Sanders 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).
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04138550
- Acronym / sponsor ID
- PUB 1114003
- Conditions
- Oral Health
- Keywords
- Social determinants, Oral health, Women, Egypt
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units selected for the survey.
Key inclusion criteria (1 listed)
- Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Social determinants
Time frame: 11 months from enrollment
Questionnaire Likert scale 1 - 5
3 secondary outcomes
Caries Experience
Time frame: 11 months from enrollment
Gingival/periodontal health
Time frame: 11 months from enrollment
Esthetics
Time frame: 11 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 17132052Mathers 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.
- Background: PubMed 20167880Frieden 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.
- BackgroundKwan 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.
- Background: PubMed 27733282GBD 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.
- Background: PubMed 25344336Steele 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.
- BackgroundWorld Health Organization. A Conceptual Framework for Action on the Social Determinants of Health. 2010.
- Background: PubMed 12084700Daly 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.
- Background: PubMed 15143115Melki 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.
- BackgroundFatima A. Al-Ghadban. Evaluating the Face Validity of an Arabic-language Translation of a Food Security Questionnaire in Arabic-speaking Populations. THESIS 2012.
- Background: PubMed 1757578Dahlem 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.
- Background: PubMed 10150421Smith 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.
- Background: PubMed 20630107Acharya 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahassen M. Farghaly, Professor study director
MIU Vice President for Community Services and Environmental Affairs
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health, run by Misr International University.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled M. Keraa, Dr ((+20)1005048718, khaled.koraa@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social determinants (time frame: 11 months from 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 NCT04138550, which also lists 14 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 16 Jul 2026.