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COVID-19 PandemicNCT06435390

Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children

An observational study of COVID-19 Pandemic, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic
How many people
155 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2019to 15 May 2022
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: This study used retrospective information for healthy 3-5 year old children with high caries risk and their parents who applied to the our University Pediatric Dentistry clinic between September 2019 and March 2020 (in the last six months before COVID-19)

Who may be able to join

  • 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.

Who cannot join

  • Childrens with systemic health problems and childrens with any space maintainers.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Zeliha Hatipoğlu Palaz

    Ankara, Biskek Street/ Emek, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: The Impact of the COVID-19 Pandemic on the Oral Hygiene Status of Children With High Caries Risk and Their Parents

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.

Read the detailed 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.

Keywords
COVID-19, oral hygiene, dietary habits, parents, pediatric dentistry
Medical subject headings
COVID-19, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06435390
Study groupRoleWhat they receive
3-5 year old 155 children with high caries risk and their parents3-5 year old 155 children with high caries risk and their parents before and after COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from 15 March to 15 May 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start1 Sep 2019
  3. Primary completion15 Mar 2022
  4. Study completion15 May 2022

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435390
Sponsor's protocol ID
E.630276
Status last verified
May 2024
First submitted
28 May 2024
Last updated
30 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34300008

  • 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.

    PubMed 35221097

  • 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.

    PubMed 32654267

  • 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.

    PubMed 33269826

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

    PubMed 7293495

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

    PubMed 7865116

  • 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.

    PubMed 33690823

  • 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.

    PubMed 36680387

  • 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.

    PubMed 33885383

  • 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.

    PubMed 7537505

  • 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.

    PubMed 36138456

  • 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.

    PubMed 34711931

  • 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.

    PubMed 34395353

  • 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.

    PubMed 22978796

  • 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.

    PubMed 36498079

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Pandemic, run by Gazi University at 1 site in Turkey (Türkiye).

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 1 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 30 May 2024. 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 Turkey (Türkiye). 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?

Changing tooth brushing and diet habits during the COVID-19 pandemic (time frame: from 15 March to 15 May 2022). 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 NCT06435390, which also lists 19 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 30 May 2024.

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