Mental Health DisorderNCT05753423
Impact of Maternal Mental Health on the Oral Health Status and Oral Health-related Quality of Life of Their Children
An observational study of Mental Health Disorder and Oral Health-Related Quality of Life, run by Ain Shams University at 1 site in Egypt.
Trial summary
Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder, Oral Health-Related Quality of Life
- What is being tested?
- Interview-based questionnaires & Clinical examination
- Type of treatment
- Pill or oral medicine
- How many people
- 262 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2022to 6 Nov 2024
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptian mothers-children pairs: preschool children of both sexes aged 3-5 years who have a full set of primary dentition and their mothers.
Who may be able to join
- Egyptian mothers.
- Preschool children of both sexes aged (3-5 years who have a full set of primary dentition).
- Healthy children with no long-term medications, and with no physical, learning, or mental disabilities.
Who cannot join
- Mothers who do not consent to participate in the study (either for themselves or for their children)
- Mothers with any diagnosed mental disorders.
- Pregnant mothers or mothers who delivered within the last year.
- Mothers with any diagnosed physical disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Maternal Depression, Anxiety, Stress, and Perceived Social Support on the Oral Health Status and Oral Health-related Quality of Life of Their Children
Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors. Based on the literature, other factors can affect child dental caries including the influence of social factors, such as the family environment. To avoid suffering from dental caries, preventive oral hygiene practices beginning in childhood are crucial. However, parents are the primary providers of oral health care for their children and they generally play a pivotal role in the overall health and oral health of both children and adolescents. Therefore, this study aims to investigate the impact of maternal mental health in the form of depression, anxiety, or stress and their perceived social support on the oral health status and OHRQoL of their children.
- Being tested
- Interview-based questionnaires & Clinical examination
- Keywords
- Mental Health, Social support, Oral Health-Related Quality of Life
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview-based questionnaires & Clinical examinationDiagnostic test
Interview-based questionnaires will be conducted among Egyptian mothers attending Pediatric Dentistry and Dental Public Health outpatient clinic at Faculty of Dentistry, Ain Shams University by the principal investigator. Clinical examination of the oral health status of their preschool children aged 3-5 years will be conducted by the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| Egyptian mothers-children pairs | Egyptian mothers-children pairs attending the Faculty of Dentistry, Ain Shams University will be recruited. Receives: Diagnostic Test: Interview-based questionnaires & Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of maternal mental issue in the form of depression, anxiety, or stress
The mental health of Egyptian mothers is assessed through the validated Arabic form of the depression anxiety stress scale-21 (DASS-21).
Measured: 1 year
The caries experience of their children (aged 3-5 years)
Dental caries experience is estimated by calculating the three components (decayed, missed, and filled) of the dmft index for primary teeth according to World Health Organization (WHO).
Measured: 1 year
The oral hygiene status of their children (aged 3-5 years)
Oral hygiene is assessed by the debris component of the modified form of Oral Hygiene Index-Simplified (OHI-S) that can be used for deciduous teeth.
Measured: 1 year
Oral health-related quality of life of their children
A validated Arabic version of the Early Childhood Oral Health Impact Scale (ECOHIS) is used to examine mothers' perceptions of their preschool children's oral health-related quality of life (OHRQoL).
Measured: 1 year
Secondary outcomes (3)
The perceived social support of Egyptian mothers
The perceived social support of Egyptian mothers is assessed by the multidimensional scale of perceived social support (Arabic- MSPSS).
Measured: 1 year
The oral health-related behaviors of their children
Egyptian mothers are asked five questions about their children's snacking habit, frequency of tooth brushing, brushing with or without adult assistance, and dental visit utilization and pattern. These questions were adopted from previous similar studies in English and then were translated into Arabic.
Measured: 1 year
The perception of Egyptian mothers about the dental health status of their children
Participants are asked to rate the dental health status of their children on a 5-point scale from 'very good' to 'very poor'.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start8 May 2022
- Primary completion27 Feb 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohammed Yehia, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753423
- Sponsor's protocol ID
- DPH 22-1D
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2017 Oral Disorders Collaborators; Bernabe E, Marcenes W, Hernandez CR, Bailey J, Abreu LG, Alipour V, Amini S, Arabloo J, Arefi Z, Arora A, Ayanore MA, Barnighausen TW, Bijani A, Cho DY, Chu DT, Crowe CS, Demoz GT, Demsie DG, Dibaji Forooshani ZS, Du M, El Tantawi M, Fischer F, Folayan MO, Futran ND, Geramo YCD, Haj-Mirzaian A, Hariyani N, Hasanzadeh A, Hassanipour S, Hay SI, Hole MK, Hostiuc S, Ilic MD, James SL, Kalhor R, Kemmer L, Keramati M, Khader YS, Kisa S, Kisa A, Koyanagi A, Lalloo R, Le Nguyen Q, London SD, Manohar ND, Massenburg BB, Mathur MR, Meles HG, Mestrovic T, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mokdad AH, Morrison SD, Nazari J, Nguyen TH, Nguyen CT, Nixon MR, Olagunju TO, Pakshir K, Pathak M, Rabiee N, Rafiei A, Ramezanzadeh K, Rios-Blancas MJ, Roro EM, Sabour S, Samy AM, Sawhney M, Schwendicke F, Shaahmadi F, Shaikh MA, Stein C, Tovani-Palone MR, Tran BX, Unnikrishnan B, Vu GT, Vukovic A, Warouw TSS, Zaidi Z, Zhang ZJ, Kassebaum NJ. Global, Regional, and National Levels and Trends in Burden of Oral Conditions from 1990 to 2017: A Systematic Analysis for the Global Burden of Disease 2017 Study. J Dent Res. 2020 Apr;99(4):362-373. doi: 10.1177/0022034520908533. Epub 2020 Mar 2.
PubMed 32122215Lorber MF, Maisson DJ, Slep AM, Heyman RE, Wolff MS. Mechanisms Linking Interparental Aggression to Child Dental Caries. Caries Res. 2017;51(2):149-159. doi: 10.1159/000453672. Epub 2017 Jan 28.
PubMed 28132053Alshammari FS, Alshammari RA, Alshammari MH, Alshammari MF, Alibrahim AK, Al Sineedi FA, Alkurdi KA, Alshammari AF. Parental Awareness and Knowledge toward their Children's Oral Health in the City of Dammam, Saudi Arabia. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):100-103. doi: 10.5005/jp-journals-10005-1894.
PubMed 34326593Abanto J, Carvalho TS, Mendes FM, Wanderley MT, Bonecker M, Raggio DP. Impact of oral diseases and disorders on oral health-related quality of life of preschool children. Community Dent Oral Epidemiol. 2011 Apr;39(2):105-14. doi: 10.1111/j.1600-0528.2010.00580.x. Epub 2010 Oct 5.
PubMed 21029148Alkan A, Cakmak O, Yilmaz S, Cebi T, Gurgan C. Relationship Between Psychological Factors and Oral Health Status and Behaviours. Oral Health Prev Dent. 2015;13(4):331-9. doi: 10.3290/j.ohpd.a32679.
PubMed 25197739Costa FDS, Azevedo MS, Ardenghi TM, Pinheiro RT, Demarco FF, Goettems ML. Do maternal depression and anxiety influence children's oral health-related quality of life? Community Dent Oral Epidemiol. 2017 Oct;45(5):398-406. doi: 10.1111/cdoe.12303. Epub 2017 Apr 17.
PubMed 28417515Gavic L, Tadin A, Mihanovic I, Gorseta K, Cigic L. The role of parental anxiety, depression, and psychological stress level on the development of early-childhood caries in children. Int J Paediatr Dent. 2018 Nov;28(6):616-623. doi: 10.1111/ipd.12419. Epub 2018 Aug 24.
PubMed 30144198Burgette JM, Polk DE, Shah N, Malik A, Crout RJ, Mcneil DW, Foxman B, Weyant RJ, Marazita ML. Mother's Perceived Social Support and Children's Dental Caries in Northern Appalachia. Pediatr Dent. 2019 May 15;41(3):200-205.
PubMed 31171071Mohammad S, Almakran IW, Al-Montashri AS, Mursi AM, Alharbi SM, Pasha TS, Khalid I. Depression, anxiety and stress and their associated social determinants in the Saudi college students. Health Psychol Res. 2020 Dec 30;8(3):9263. doi: 10.4081/hpr.2020.9263. eCollection 2020 Dec 30.
PubMed 33553792
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Depression, Anxiety, Stress, and Perceived Social Support on the Oral Health Status and Oral Health-related Quality of Life of Their Children
- ClinicalTrials.gov ID
- NCT05753423
- Acronym / sponsor ID
- DPH 22-1D
- Keywords
- Mental Health, Social support, Oral Health-Related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 3 Mar 2023 (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.
Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors. Based on the literature, other factors can affect child dental caries including the influence of social factors, such as the family environment. To avoid suffering from dental caries, preventive oral hygiene practices beginning in childhood are crucial. However, parents are the primary providers of oral health care for their children and they generally play a pivotal role in the overall health and oral health of both children and adolescents. Therefore, this study aims to investigate the impact of maternal mental health in the form of depression, anxiety, or stress and their perceived social support on the oral health status and OHRQoL of their children.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egyptian mothers-children pairs | – | Diagnostic Test: Interview-based questionnaires & Clinical examinationEgyptian mothers-children pairs attending the Faculty of Dentistry, Ain Shams University will be recruited. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian mothers-children pairs: preschool children of both sexes aged 3-5 years who have a full set of primary dentition and their mothers.
Key inclusion criteria (3 listed)
- Egyptian mothers.
- Preschool children of both sexes aged (3-5 years who have a full set of primary dentition).
- Healthy children with no long-term medications, and with no physical, learning, or mental disabilities.
Key exclusion criteria (4 listed)
- Mothers who do not consent to participate in the study (either for themselves or for their children)
- Mothers with any diagnosed mental disorders.
- Pregnant mothers or mothers who delivered within the last year.
- Mothers with any diagnosed physical disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview-based questionnaires & Clinical examinationInterview-based questionnaires will be conducted among Egyptian mothers attending Pediatric Dentistry and Dental Public Health outpatient clinic at Faculty of Dentistry, Ain Shams University by the principal investigator. Clinical examination of the oral health status of their preschool children aged 3-5 years will be conducted by the principal investigator. | Diagnostic test | Egyptian mothers-children pairs |
Primary outcome
The presence of maternal mental issue in the form of depression, anxiety, or stress
Time frame: 1 year
The mental health of Egyptian mothers is assessed through the validated Arabic form of the depression anxiety stress scale-21 (DASS-21).
The caries experience of their children (aged 3-5 years)
Time frame: 1 year
Dental caries experience is estimated by calculating the three components (decayed, missed, and filled) of the dmft index for primary teeth according to World Health Organization (WHO).
The oral hygiene status of their children (aged 3-5 years)
Time frame: 1 year
Oral hygiene is assessed by the debris component of the modified form of Oral Hygiene Index-Simplified (OHI-S) that can be used for deciduous teeth.
Oral health-related quality of life of their children
Time frame: 1 year
A validated Arabic version of the Early Childhood Oral Health Impact Scale (ECOHIS) is used to examine mothers' perceptions of their preschool children's oral health-related quality of life (OHRQoL).
3 secondary outcomes
The perceived social support of Egyptian mothers
Time frame: 1 year
The oral health-related behaviors of their children
Time frame: 1 year
The perception of Egyptian mothers about the dental health status of their children
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 32122215GBD 2017 Oral Disorders Collaborators; Bernabe E, Marcenes W, Hernandez CR, Bailey J, Abreu LG, Alipour V, Amini S, Arabloo J, Arefi Z, Arora A, Ayanore MA, Barnighausen TW, Bijani A, Cho DY, Chu DT, Crowe CS, Demoz GT, Demsie DG, Dibaji Forooshani ZS, Du M, El Tantawi M, Fischer F, Folayan MO, Futran ND, Geramo YCD, Haj-Mirzaian A, Hariyani N, Hasanzadeh A, Hassanipour S, Hay SI, Hole MK, Hostiuc S, Ilic MD, James SL, Kalhor R, Kemmer L, Keramati M, Khader YS, Kisa S, Kisa A, Koyanagi A, Lalloo R, Le Nguyen Q, London SD, Manohar ND, Massenburg BB, Mathur MR, Meles HG, Mestrovic T, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mokdad AH, Morrison SD, Nazari J, Nguyen TH, Nguyen CT, Nixon MR, Olagunju TO, Pakshir K, Pathak M, Rabiee N, Rafiei A, Ramezanzadeh K, Rios-Blancas MJ, Roro EM, Sabour S, Samy AM, Sawhney M, Schwendicke F, Shaahmadi F, Shaikh MA, Stein C, Tovani-Palone MR, Tran BX, Unnikrishnan B, Vu GT, Vukovic A, Warouw TSS, Zaidi Z, Zhang ZJ, Kassebaum NJ. Global, Regional, and National Levels and Trends in Burden of Oral Conditions from 1990 to 2017: A Systematic Analysis for the Global Burden of Disease 2017 Study. J Dent Res. 2020 Apr;99(4):362-373. doi: 10.1177/0022034520908533. Epub 2020 Mar 2.
- Background: PubMed 28132053Lorber MF, Maisson DJ, Slep AM, Heyman RE, Wolff MS. Mechanisms Linking Interparental Aggression to Child Dental Caries. Caries Res. 2017;51(2):149-159. doi: 10.1159/000453672. Epub 2017 Jan 28.
- Background: PubMed 34326593Alshammari FS, Alshammari RA, Alshammari MH, Alshammari MF, Alibrahim AK, Al Sineedi FA, Alkurdi KA, Alshammari AF. Parental Awareness and Knowledge toward their Children's Oral Health in the City of Dammam, Saudi Arabia. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):100-103. doi: 10.5005/jp-journals-10005-1894.
- Background: PubMed 21029148Abanto J, Carvalho TS, Mendes FM, Wanderley MT, Bonecker M, Raggio DP. Impact of oral diseases and disorders on oral health-related quality of life of preschool children. Community Dent Oral Epidemiol. 2011 Apr;39(2):105-14. doi: 10.1111/j.1600-0528.2010.00580.x. Epub 2010 Oct 5.
- Background: PubMed 25197739Alkan A, Cakmak O, Yilmaz S, Cebi T, Gurgan C. Relationship Between Psychological Factors and Oral Health Status and Behaviours. Oral Health Prev Dent. 2015;13(4):331-9. doi: 10.3290/j.ohpd.a32679.
- Background: PubMed 28417515Costa FDS, Azevedo MS, Ardenghi TM, Pinheiro RT, Demarco FF, Goettems ML. Do maternal depression and anxiety influence children's oral health-related quality of life? Community Dent Oral Epidemiol. 2017 Oct;45(5):398-406. doi: 10.1111/cdoe.12303. Epub 2017 Apr 17.
- Background: PubMed 30144198Gavic L, Tadin A, Mihanovic I, Gorseta K, Cigic L. The role of parental anxiety, depression, and psychological stress level on the development of early-childhood caries in children. Int J Paediatr Dent. 2018 Nov;28(6):616-623. doi: 10.1111/ipd.12419. Epub 2018 Aug 24.
- Background: PubMed 31171071Burgette JM, Polk DE, Shah N, Malik A, Crout RJ, Mcneil DW, Foxman B, Weyant RJ, Marazita ML. Mother's Perceived Social Support and Children's Dental Caries in Northern Appalachia. Pediatr Dent. 2019 May 15;41(3):200-205.
- Background: PubMed 33553792Mohammad S, Almakran IW, Al-Montashri AS, Mursi AM, Alharbi SM, Pasha TS, Khalid I. Depression, anxiety and stress and their associated social determinants in the Saudi college students. Health Psychol Res. 2020 Dec 30;8(3):9263. doi: 10.4081/hpr.2020.9263. eCollection 2020 Dec 30.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Disorder and Oral Health-Related Quality of Life, run by Ain Shams 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 3 inclusion and 4 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 28 Mar 2025. 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?
The presence of maternal mental issue in the form of depression, anxiety, or stress (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT05753423, 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 28 Mar 2025.