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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05753423
Other study ID # DPH 22-1D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 8, 2022
Est. completion date June 2024

Study information

Verified date March 2023
Source Ain Shams University
Contact Alaa Mohammed Yehia, Ass Lecturer
Phone 01124488422
Email alaa.mohamed.asu@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date June 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Interview-based questionnaires & Clinical examination
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.

Locations

Country Name City State
Egypt Faculty of Dentistry, Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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). 1 year
Secondary 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. 1 year
Secondary 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'. 1 year
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