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Status unknownNCT03158155Updated Jun 7, 2017

Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.

An observational study in Vitamin D Deficiency, sponsored by Nancy Ahmed El Salmawy. Status unknown. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by Nancy Ahmed El Salmawy · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
288
Ages
2 Years to 5 Years
Sex
All
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Study summary

To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.

Read the detailed description

Justification for undertaking the trial:

American Academy of Pediatric Dentistry (2012), defined early childhood caries (ECC) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger.

Early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (Guay, 2004).

Due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (Guay, 2004).These multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( Najeeb et al., 2016).

Enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. Vitamin D plays an important role in increasing the absorption of calcium and phosphate from food. Which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (Youssef et al., 2011). Therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (Mellanby \& Pattison, 1928).

Vitamin D receptors are present on the cells of immune system and on the teeth. It binds to these receptors and increases the amount of good antimicrobial proteins as cathelicidin and other special defense in saliva (Youssef et al., 2011). These antimicrobial peptides have antibacterial neutralizing activity against periodonto pathogens as gram negative and gram positive bacteria and candida albicans, its effective in vitro against oral microorganisms such as streptococcus mutants, prophyromonas gingivalis and actinobacillus, so it prevents dental caries.( Potturu et al., 2014).

East, (1939) study concluded that children who consumed a high vitamin D diet, vitamin D played an indispensable role in 1) preventing the initiation of new caries, 2) inhibiting the spread of existing caries, and 3) arresting the caries. Likewise, an examination of children found a decreased caries prevalence in areas of increased vitamin D exposure.

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Conditions studied

  • Vitamin D Deficiency

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03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's planned enrollment of 288 is above the median of 138 across 183 observational studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

This is the only study on the registry with Nancy Ahmed El Salmawy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Egyptain children age ranges from 2 to 5 years from Abo El Rish Hospital, Malnutrition clinic.

Inclusion criteria

  1. Children ages from two to five years
  2. Both sexes.
  3. Parent and children cooperation.
  4. Healthy children.
  5. Children with serum vitamin D deficiency.

Exclusion criteria

Exclusion Criteria:

  1. Children age more than 5 years.
  2. Children had a complex metabolic or medical disorder.
  3. Parents that will not sign the consent.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
288 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with vitamin D deficiency

    1. children with vitamin D deficiency with age group from 2-5 years old

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What researchers measure

Primary outcomes

  1. Prevalence of early childhood caries

    Stages of Early childhood caries. 1. Initial (reversible stage) 2. Damaged (carious) stage 3. Deep lesions 4. Traumatic stage. 5. Arrested caries.

    Time frame: 6 months

Secondary outcomes

  1. Delayed tooth formation and eruption

    * Delayed tooth eruption. * Tooth smaller than normal

    Time frame: 6 months

  2. Gingivitis

    binary yes or no

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Policy on Early Childhood Caries (ECC): Classifications, Consequences, and Preventive Strategies. Pediatr Dent. 2016 Oct;38(6):52-54. No abstract available. PubMed 27931420 ↗
  • Anthonappa, R. P., and King, N. M. (2015). Enamel defects in the permanent dentition: prevalence and etiology. Springer-Verlag Berlin Heidelberg 2015; B.K. Drummond, N. Kilpatrick (eds.), Planning and Care for Children and Adolescents with Dental Enamel Defects: Etiology, Research and Contemporary Management, pp. 15-30
  • Antonenko O, Bryk G, Brito G, Pellegrini G, Zeni SN. Oral health in young women having a low calcium and vitamin D nutritional status. Clin Oral Investig. 2015 Jul;19(6):1199-206. doi: 10.1007/s00784-014-1343-x. Epub 2014 Oct 31. PubMed 25359326 ↗
  • Baumann, F., Jäger, E., & Bloch, W. (2013).Vitamin D -office of dietary supplements-National instituted health. Journal of Molecular Modeling
  • Bener, A., Al Darwish, M. S., and Hoffmann , G. F. (2013). Vitamin D deficiency and risk of dental caries among young children: A public health problem. Indian Journal of Oral Sciences, 4(2): 75-82
  • Bener A, Alsaied A, Al-Ali M, Al-Kubaisi A, Basha B, Abraham A, Guiter G, Mian M. High prevalence of vitamin D deficiency in type 1 diabetes mellitus and healthy children. Acta Diabetol. 2009 Sep;46(3):183-9. doi: 10.1007/s00592-008-0071-6. Epub 2008 Oct 10. PubMed 18846317 ↗
  • Wagner CL, Greer FR; American Academy of Pediatrics Section on Breastfeeding; American Academy of Pediatrics Committee on Nutrition. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008 Nov;122(5):1142-52. doi: 10.1542/peds.2008-1862. Erratum In: Pediatrics. 2009 Jan;123(1):197. PubMed 18977996 ↗
  • Douglass JM, Douglass AB, Silk HJ. A practical guide to infant oral health. Am Fam Physician. 2004 Dec 1;70(11):2113-20. PubMed 15606059 ↗
  • Dudding T, Thomas SJ, Duncan K, Lawlor DA, Timpson NJ. Re-Examining the Association between Vitamin D and Childhood Caries. PLoS One. 2015 Dec 21;10(12):e0143769. doi: 10.1371/journal.pone.0143769. eCollection 2015. PubMed 26692013 ↗
  • East BR. Mean Annual Hours of Sunshine and the Incidence of Dental Caries. Am J Public Health Nations Health. 1939 Jul;29(7):777-80. doi: 10.2105/ajph.29.7.777. No abstract available. PubMed 18015076 ↗
  • Fuleihan Gel-H, Bouillon R, Clarke B, Chakhtoura M, Cooper C, McClung M, Singh RJ. Serum 25-Hydroxyvitamin D Levels: Variability, Knowledge Gaps, and the Concept of a Desirable Range. J Bone Miner Res. 2015 Jul;30(7):1119-33. doi: 10.1002/jbmr.2536. Epub 2015 May 7. PubMed 25952470 ↗
  • Grant WB. A review of the role of solar ultraviolet-B irradiance and vitamin D in reducing risk of dental caries. Dermatoendocrinol. 2011 Jul;3(3):193-8. doi: 10.4161/derm.3.3.15841. Epub 2011 Jul 1. PubMed 22110779 ↗
  • Guay AH. Access to dental care: solving the problem for underserved populations. J Am Dent Assoc. 2004 Nov;135(11):1599-605; quiz 1623. doi: 10.14219/jada.archive.2004.0088. PubMed 15622666 ↗
  • Herzog K, Scott JM, Hujoel P, Seminario AL. Association of vitamin D and dental caries in children: Findings from the National Health and Nutrition Examination Survey, 2005-2006. J Am Dent Assoc. 2016 Jun;147(6):413-20. doi: 10.1016/j.adaj.2015.12.013. Epub 2016 Jan 27. PubMed 26827077 ↗
  • Krall EA, Wehler C, Garcia RI, Harris SS, Dawson-Hughes B. Calcium and vitamin D supplements reduce tooth loss in the elderly. Am J Med. 2001 Oct 15;111(6):452-6. doi: 10.1016/s0002-9343(01)00899-3. PubMed 11690570 ↗
  • Mellanby M, Pattison CL. THE ACTION OF VITAMIN D IN PREVENTING THE SPREAD AND PROMOTING THE ARREST OF CARIES IN CHILDREN. Br Med J. 1928 Dec 15;2(3545):1079-82. doi: 10.1136/bmj.2.3545.1079. No abstract available. PubMed 20774325 ↗
  • Najeeb S, Zafar MS, Khurshid Z, Zohaib S, Almas K. The Role of Nutrition in Periodontal Health: An Update. Nutrients. 2016 Aug 30;8(9):530. doi: 10.3390/nu8090530. PubMed 27589794 ↗
  • Youssef DA, Miller CW, El-Abbassi AM, Cutchins DC, Cutchins C, Grant WB, Peiris AN. Antimicrobial implications of vitamin D. Dermatoendocrinol. 2011 Oct;3(4):220-9. doi: 10.4161/derm.3.4.15027. Epub 2011 Oct 1. PubMed 22259647 ↗
  • Potturu, M., Prabhakaran, P. A., Oommen, N., Sarojini, D. M., and Sunil, S. N.(2014). Cathelicidin expression and role in oral health and diseases: A short review. Tropical J. of Med. Res., 17 (2): 69-75.
  • Schroth RJ, Lavelle C, Tate R, Bruce S, Billings RJ, Moffatt ME. Prenatal vitamin D and dental caries in infants. Pediatrics. 2014 May;133(5):e1277-84. doi: 10.1542/peds.2013-2215. PubMed 24753535 ↗
  • American Academy of Pediatric Dentistry Clinical Affairs Committee; American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on periodicity of examination, preventive dental services, anticipatory guidance, and oral treatment for children. Pediatr Dent. 2005-2006;27(7 Suppl):84-6. No abstract available. PubMed 16541901 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03158155
Lead sponsor
Nancy Ahmed El Salmawy
Responsible party
Nancy Ahmed El Salmawy (Principal Investigator,, Cairo University) — Sponsor-investigator
First posted
May 18, 2017
Start date
Jul 15, 2017 (estimated)
Primary completion
Jul 15, 2018 (estimated)
Completion
Jul 18, 2018 (estimated)
Last update
Jun 7, 2017

Study contacts

Nancy A El salmawy, Master
Contact
nancyyy_911@hotmain.com
+201001891010
Nourhan A. El dokky, A. Professor
study director · neldokky@hotmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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