NCT06130189

Brief Summary

The main risk factors for dental caries are inadequate oral hygiene practices, cariogenic bacteria, and cariogenic diet. Among these factors, diet has a different dual relationship with dental caries. Dietary habits have the potential to be a risk factor for dental caries impaired oral and dental health can also lead to deficiencies in dietary intake. Studies have shown that there is a decrease in gum and periodontal diseases in the adult age group with a diet compatible with the Mediterranean diet. This cross-sectional study aims to examine the relationship between a diet compatible with the Mediterranean Diet and dental caries and gum health status in children. We hypothesize that children will have better gum health and less tooth decay with a diet compatible with the Mediterranean diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

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

October 17, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

November 7, 2023

Last Update Submit

October 1, 2025

Conditions

Diet HabitFamily CharacteristicsTooth DecayPeriodontal Health

Keywords

childrendental cariesmediterranean dietoral health

Outcome Measures

Primary Outcomes (1)

  • Caries experiences

    Oral examinations of children will be performed by a single experienced pediatric dentist, using a mirror and probe, in the dentist's chair, and under appropriate lighting. Caries, extracted due to caries, filled primary and permanent teeth, and tooth surfaces in the child will be evaluated according to the caries index criteria of the World Health Organization (WHO-2013).

    during enrollment once

Secondary Outcomes (5)

  • plaque index measurement

    during enrollment once

  • gingival index measurement

    during enrollment once

  • Mediterranean Diet Quality Scale (KIDMED):

    during enrollment once

  • Family Nutrition and Physical Activity screening tool (FNPA):

    during enrollment once

  • 24-hour retrospective food consumption record:

    during enrollment once

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

It is planned to include healthy children between the ages of 0-14 who apply to Ankara Medipol University Oral and Dental Health Practice and Research Center Pedodontics Clinic. Parents of children who meet the study criteria will be informed about the research and an informed consent form will be obtained.

You may qualify if:

  • Between the ages of 3-14
  • Not having a chronic/systemic disease (diabetes, allergies, etc.)
  • Not having received radiotherapy or chemotherapy treatment
  • Not having a mental or psychiatric disorder
  • Agreeing to participate in the study

You may not qualify if:

  • Over 14 years old and under 3 years old
  • Having a chronic/systemic disease (diabetes, allergies, etc.)
  • Having received radiotherapy or chemotherapy treatment
  • Having a mental or psychiatric disorder
  • Not agreeing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University Oral and Dental Health Practice and Research Center Pedodontics Clinic

Ankara, Turkey (Türkiye)

Location

Related Publications (16)

  • Sofi F, Abbate R, Gensini GF, Casini A. Accruing evidence on benefits of adherence to the Mediterranean diet on health: an updated systematic review and meta-analysis. Am J Clin Nutr. 2010 Nov;92(5):1189-96. doi: 10.3945/ajcn.2010.29673. Epub 2010 Sep 1.

    PMID: 20810976BACKGROUND

  • Bonaccio M, Di Castelnuovo A, Costanzo S, De Lucia F, Olivieri M, Donati MB, de Gaetano G, Iacoviello L, Bonanni A; Moli-sani Project Investigators. Nutrition knowledge is associated with higher adherence to Mediterranean diet and lower prevalence of obesity. Results from the Moli-sani study. Appetite. 2013 Sep;68:139-46. doi: 10.1016/j.appet.2013.04.026. Epub 2013 May 7.

    PMID: 23665233BACKGROUND

  • Bosma-den Boer MM, van Wetten ML, Pruimboom L. Chronic inflammatory diseases are stimulated by current lifestyle: how diet, stress levels and medication prevent our body from recovering. Nutr Metab (Lond). 2012 Apr 17;9(1):32. doi: 10.1186/1743-7075-9-32.

    PMID: 22510431BACKGROUND

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464BACKGROUND

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956BACKGROUND

  • Şahingöz, S. A., Özgen, L., & Yalçın, E. (2019). Akdeniz Diyet Kalitesi Ölçeğinin (Mediterranean Diet Quality-KIDMED) Geçerlik ve Güvenirlik Çalışması. Proceedings Book of 5th International Eurasian Congress on Natural Nutrition, Healthy Life & Sport, 1078-1088. 02-06 October 2019, Ankara/Turkey.

    BACKGROUND

  • Ihmels MA, Welk GJ, Eisenmann JC, Nusser SM. Development and preliminary validation of a Family Nutrition and Physical Activity (FNPA) screening tool. Int J Behav Nutr Phys Act. 2009 Mar 12;6:14. doi: 10.1186/1479-5868-6-14.

    PMID: 19284631BACKGROUND

  • Ekıcı, E. , Ikıısık, H. , Ankaralı, H. , Manav, G. , Colak, M. & Kozan, E. H. (2021). The validity and reliability of the Turkish version of the Family Nutrition and Physical Activity screening tool . Marmara Medical Journal , 34 (3) , 319-326 . DOI: 10.5472/marumj.1009125

    BACKGROUND

  • Pekcan, G. (2008). Beslenme durumunun saptanmasi. Diyet El Kitabi, 726, 67-141.

    BACKGROUND

  • Woelber JP, Bremer K, Vach K, Konig D, Hellwig E, Ratka-Kruger P, Al-Ahmad A, Tennert C. An oral health optimized diet can reduce gingival and periodontal inflammation in humans - a randomized controlled pilot study. BMC Oral Health. 2016 Jul 26;17(1):28. doi: 10.1186/s12903-016-0257-1.

    PMID: 27460471RESULT

  • Kim HS, Park JW, Yeo SI, Choi BJ, Suh JY. Effects of high glucose on cellular activity of periodontal ligament cells in vitro. Diabetes Res Clin Pract. 2006 Oct;74(1):41-7. doi: 10.1016/j.diabres.2006.03.034. Epub 2006 Jun 30.

    PMID: 16814898RESULT

  • Hujoel P. Dietary carbohydrates and dental-systemic diseases. J Dent Res. 2009 Jun;88(6):490-502. doi: 10.1177/0022034509337700.

    PMID: 19587153RESULT

  • Saenz-Ravello G, Matamala L, Cisternas P, Gamonal J, Hernandez P, Santos NCD, Deng K, Baeza M. Association between the Mediterranean Diet Index and self-reported Gingival Health Status Indicators in a population of Chilean adults: a cross-sectional study. J Appl Oral Sci. 2023 Jul 3;31:e20230100. doi: 10.1590/1678-7757-2023-0100. eCollection 2023.

    PMID: 37403879RESULT

  • Altun E, Walther C, Borof K, Petersen E, Lieske B, Kasapoudis D, Jalilvand N, Beikler T, Jagemann B, Zyriax BC, Aarabi G. Association between Dietary Pattern and Periodontitis-A Cross-Sectional Study. Nutrients. 2021 Nov 21;13(11):4167. doi: 10.3390/nu13114167.

    PMID: 34836422RESULT

  • Tennert C, Reinmuth AC, Bremer K, Al-Ahmad A, Karygianni L, Hellwig E, Vach K, Ratka-Kruger P, Wittmer A, Woelber JP. An oral health optimized diet reduces the load of potential cariogenic and periodontal bacterial species in the supragingival oral plaque: A randomized controlled pilot study. Microbiologyopen. 2020 Aug;9(8):e1056. doi: 10.1002/mbo3.1056. Epub 2020 May 17.

    PMID: 32419378RESULT

  • Laiola M, De Filippis F, Vitaglione P, Ercolini D. A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects. Appl Environ Microbiol. 2020 Jun 2;86(12):e00777-20. doi: 10.1128/AEM.00777-20. Print 2020 Jun 2.

    PMID: 32276980RESULT

MeSH Terms

Conditions

Feeding BehaviorDental Caries

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Gülsevim ODA, PhD

    Ankara Medipol University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

  • Merve Ekici, PhD

    Department of Nutrition and Dietetics, University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 14, 2023

Study Start

October 17, 2023

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)