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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06435390
Other study ID # E.630276
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date May 15, 2022

Study information

Verified date May 2024
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare oral hygiene status and dietary habits of 3-5 years old children and their parents with a questionnaire and clinic examination between pre- and post-COVID-19 period.


Description:

Study Rationale and Objectives: The primary motivation behind this study lies in understanding the impact of the COVID-19 pandemic on oral health behaviors, specifically focusing on children at high risk for dental caries. Objectives include assessing changes in tooth brushing habits and dietary patterns among both children and their parents. Study Design: The study employs a prospective observational design. Participants are parents of 155 children aged 3-5 years. Data collection occurs at two time points: before and after the COVID-19 pandemic. Data Collection Instruments: A structured questionnaire is administered to parents. It covers: Children's and parents' dietary habits (frequency of sugary food consumption). Oral hygiene practices (tooth brushing frequency). The index of decayed-missing-filled deciduous teeth (dmft) is used to assess dental caries status in children. The COVID-19 pandemic had a limited impact on high-caries-risk children's tooth brushing habits. However, increased sugary food consumption by both children and parents exacerbated caries risk. Collaborative efforts between healthcare professionals and parents are crucial to mitigate negative oral health effects during such challenging times.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date May 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - 3-5 year old children with high caries risk. To identify high caries-risk children, the criteria used by the the American Academy of Pediatric Dentistry (AAPD) for assessing a child's dental caries risk were applied. Exclusion Criteria: - Childrens with systemic health problems and childrens with any space maintainers.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Zeliha Hatipoglu Palaz Ankara Biskek Street/ Emek

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (19)

Angelopoulou MV, Seremidi K, Papaioannou W, Gizani S. Impact of the COVID-19 lockdown on the oral health status of paediatric dental patients in Greece. Int J Paediatr Dent. 2023 May;33(3):246-253. doi: 10.1111/ipd.13048. Epub 2023 Mar 13. — View Citation

Blumer S, Dagon N, Peretz B, Ratson T, Kharouba J. Function of the Family Unit, Oral Hygiene Rules and Attitudes to Dental Health in Children During First-Wave 2020 COVID-19 Lockdown. J Clin Pediatr Dent. 2021 Jan 1;45(1):1-7. doi: 10.17796/1053-4625-45.1.1. — View Citation

Bonneau JC. [Contact allergy to sulfites: contact allergens, sources of exposure, and clinical profile]. Allerg Immunol (Paris). 1994 Nov;26(9):324-6. French. — View Citation

Caramida M, Dumitrache MA, Tancu AMC, Ilici RR, Ilinca R, Sfeatcu R. Oral Habits during the Lockdown from the SARS-CoV-2 Pandemic in the Romanian Population. Medicina (Kaunas). 2022 Mar 5;58(3):387. doi: 10.3390/medicina58030387. — View Citation

Costa AL, Pereira JL, Franco L, Guinot F. COVID-19 Lockdown: Impact on Oral Health-Related Behaviors and Practices of Portuguese and Spanish Children. Int J Environ Res Public Health. 2022 Nov 30;19(23):16004. doi: 10.3390/ijerph192316004. — View Citation

Daly J, Black EAM. The impact of COVID-19 on population oral health. Community Dent Health. 2020 Nov 30;37(4):236-238. doi: 10.1922/CDH_Dec20editorialDalyBlack03. — View Citation

Dickson-Swift V, Kangutkar T, Knevel R, Down S. The impact of COVID-19 on individual oral health: a scoping review. BMC Oral Health. 2022 Sep 22;22(1):422. doi: 10.1186/s12903-022-02463-0. — View Citation

Docimo R, Costacurta M, Gualtieri P, Pujia A, Leggeri C, Attina A, Cinelli G, Giannattasio S, Rampello T, Di Renzo L. Cariogenic Risk and COVID-19 Lockdown in a Paediatric Population. Int J Environ Res Public Health. 2021 Jul 15;18(14):7558. doi: 10.3390/ijerph18147558. — View Citation

Goswami M, Grewal M, Garg A. Attitude and practices of parents toward their children's oral health care during COVID-19 pandemic. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):22-28. doi: 10.4103/jisppd.jisppd_478_20. — View Citation

Gotler M, Oren L, Spierer S, Yarom N, Ashkenazi M. The impact of COVID-19 lockdown on maintenance of children's dental health: A questionnaire-based survey. J Am Dent Assoc. 2022 May;153(5):440-449. doi: 10.1016/j.adaj.2021.10.004. Epub 2021 Oct 19. — View Citation

Greuter W. [Practical industrial medicine in Switzerland]. Soz Praventivmed. 1981 Jul;26(3):126-9. doi: 10.1007/BF02081368. German. — View Citation

Hamilton K, Cornish S, Kirkpatrick A, Kroon J, Schwarzer R. Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control. Br J Health Psychol. 2018 May;23(2):387-406. doi: 10.1111/bjhp.12294. Epub 2018 Jan 18. — View Citation

Kotha SB, AlFaraj NSM, Ramdan TH, Alsalam MA, Al Ameer MJ, Almuzin ZM. Associations between Diet, Dietary and Oral Hygiene Habits with Caries Occurrence and Severity in Children with Autism at Dammam City, Saudi Arabia. Open Access Maced J Med Sci. 2018 Jun 6;6(6):1104-1110. doi: 10.3889/oamjms.2018.245. eCollection 2018 Jun 20. — View Citation

Mahagna M, Nir I, Larbier M, Nitsan Z. Effect of age and exogenous amylase and protease on development of the digestive tract, pancreatic enzyme activities and digestibility of nutrients in young meat-type chicks. Reprod Nutr Dev. 1995;35(2):201-12. doi: 10.1051/rnd:19950208. — View Citation

Mohapatra RK, Pintilie L, Kandi V, Sarangi AK, Das D, Sahu R, Perekhoda L. The recent challenges of highly contagious COVID-19, causing respiratory infections: Symptoms, diagnosis, transmission, possible vaccines, animal models, and immunotherapy. Chem Biol Drug Des. 2020 Nov;96(5):1187-1208. doi: 10.1111/cbdd.13761. Epub 2020 Jul 26. — View Citation

Navarro-Perez CF, Fernandez-Aparicio A, Gonzalez-Jimenez E, Montero-Alonso MA, Schmidt-RioValle J. Effects of COVID-19 lockdown on the dietary habits and lifestyle in a population in southern Spain: a cross-sectional questionnaire. Eur J Clin Nutr. 2022 Jun;76(6):883-890. doi: 10.1038/s41430-021-01034-w. Epub 2021 Oct 28. — View Citation

Olszewska A, Paszynska E, Roszak M, Czajka-Jakubowska A. Management of the Oral Health of Children During the COVID-19 Pandemic in Poland. Front Public Health. 2021 Jul 29;9:635081. doi: 10.3389/fpubh.2021.635081. eCollection 2021. — View Citation

Ruiz-Roso MB, de Carvalho Padilha P, Mantilla-Escalante DC, Ulloa N, Brun P, Acevedo-Correa D, Arantes Ferreira Peres W, Martorell M, Aires MT, de Oliveira Cardoso L, Carrasco-Marin F, Paternina-Sierra K, Rodriguez-Meza JE, Montero PM, Bernabe G, Pauletto A, Taci X, Visioli F, Davalos A. Covid-19 Confinement and Changes of Adolescent's Dietary Trends in Italy, Spain, Chile, Colombia and Brazil. Nutrients. 2020 Jun 17;12(6):1807. doi: 10.3390/nu12061807. — View Citation

Tellez M, Gomez J, Pretty I, Ellwood R, Ismail AI. Evidence on existing caries risk assessment systems: are they predictive of future caries? Community Dent Oral Epidemiol. 2013 Feb;41(1):67-78. doi: 10.1111/cdoe.12003. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Changing tooth brushing and diet habits during the COVID-19 pandemic Changing tooth brushing and diet habits of 155 children aged 3-5 with high risk of caries during the COVID-19 pandemic period from 15 March to 15 May 2022
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