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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03158155
• Other study ID #: CEBD-2017-5-101
• Status: Not yet recruiting
• Phase: N/A
• First received: May 16, 2017
• Last updated: June 5, 2017
• Start date: July 15, 2017
• Est. completion date: July 18, 2018

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: Nancy A El salmawy, Master
• Phone: +201001891010
• Email: nancyyy_911[@]hotmain.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: July 18, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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:

1. Children age more than 5 years.

2. Children had a complex metabolic or medical disorder.

3. Parents that will not sign the consent.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nancy Ahmed El Salmawy

References & Publications (21)

American Academy of Pediatric Dentistry (2015). Guideline on periodicity of examination, preventive dental services, anticipatory guidance, and oral treatment for children. Pediatr. Dent., 37 (special issue):123-131

American Academy of Pediatric Dentistry: Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2012, 34 (6): 50-52

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. — View Citation

Baumann, F., Jäger, E., & Bloch, W. (2013).Vitamin D -office of dietary supplements-National instituted health. Journal of Molecular Modeling

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. — View Citation

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

Douglass JM, Douglass AB, Silk HJ. A practical guide to infant oral health. Am Fam Physician. 2004 Dec 1;70(11):2113-20. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Guay AH. Access to dental care: solving the problem for underserved populations. J Am Dent Assoc. 2004 Nov;135(11):1599-605; quiz 1623. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: E530. doi: 10.3390/nu8090530. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of early childhood caries	Stages of Early childhood caries.; Initial (reversible stage); Damaged (carious) stage; Deep lesions; Traumatic stage.; Arrested caries.	6 months
Secondary	Delayed tooth formation and eruption	Delayed tooth eruption.; Tooth smaller than normal	6 months
Secondary	Gingivitis	binary yes or no	6 months