Clinical trial NCT03158155: Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.
Official title: Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 288
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptain children age ranges from 2 to 5 years from Abo El Rish Hospital, Malnutrition clinic.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of early childhood caries
timeFrame: 6 months
Secondary outcomes:
measure: Delayed tooth formation and eruption
timeFrame: 6 months
measure: Gingivitis
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: neldokky@hotmail.com
name: Nourhan A. El dokky, A. Professor
role: STUDY_DIRECTOR
References:
citation: Policy on Early Childhood Caries (ECC): Classifications, Consequences, and Preventive Strategies. Pediatr Dent. 2016 Oct;38(6):52-54. No abstract available.
citation: 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
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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.
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