NCT05753423

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

February 21, 2023

Last Update Submit

March 27, 2025

Conditions

Keywords

Mental HealthSocial supportOral Health-Related Quality of Life

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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.

    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).

    1 year

Secondary Outcomes (3)

  • The perceived social support of Egyptian mothers

    1 year

  • The oral health-related behaviors of their children

    1 year

  • The perception of Egyptian mothers about the dental health status of their children

    1 year

Study Arms (1)

Egyptian mothers-children pairs

Egyptian mothers-children pairs attending the Faculty of Dentistry, Ain Shams University will be recruited.

Diagnostic Test: Interview-based questionnaires & Clinical examination

Interventions

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.

Egyptian mothers-children pairs

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (9)

  • 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.

    PMID: 32122215BACKGROUND
  • Lorber 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.

    PMID: 28132053BACKGROUND
  • Alshammari 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.

    PMID: 34326593BACKGROUND
  • Abanto 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.

    PMID: 21029148BACKGROUND
  • Alkan 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.

    PMID: 25197739BACKGROUND
  • Costa 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.

    PMID: 28417515BACKGROUND
  • Gavic 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.

    PMID: 30144198BACKGROUND
  • Burgette 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.

    PMID: 31171071BACKGROUND
  • Mohammad 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.

    PMID: 33553792BACKGROUND

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 3, 2023

Study Start

May 8, 2022

Primary Completion

February 27, 2024

Study Completion

November 6, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations