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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158155
Recruitment Status : Unknown
Verified June 2017 by Nancy Ahmed El Salmawy, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Nancy Ahmed El Salmawy, Cairo University

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

Condition or disease
Vitamin D Deficiency

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 288 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : July 15, 2018
Estimated Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
Patients with vitamin D deficiency
1. children with vitamin D deficiency with age group from 2-5 years old



Primary Outcome Measures :
  1. Prevalence of early childhood caries [ Time Frame: 6 months ]

    Stages of Early childhood caries.

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


Secondary Outcome Measures :
  1. Delayed tooth formation and eruption [ Time Frame: 6 months ]
    • Delayed tooth eruption.
    • Tooth smaller than normal

  2. Gingivitis [ Time Frame: 6 months ]
    binary yes or no


Biospecimen Retention:   Samples Without DNA
Blood samples will be obtained from children recruited in the study at the day of diagnosis, seven mm of blood will collect approximately, using radioimmunoassay technique for measuring vitamin D serum level All serum analysis will be done in Radioisotope Department, Nuclear Research Center, and Atomic Energy Authority.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158155


Contacts
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Contact: Nancy A El salmawy, Master +201001891010 nancyyy_911@hotmain.com

Sponsors and Collaborators
Nancy Ahmed El Salmawy
Investigators
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Study Director: Nourhan A. El dokky, A. Professor neldokky@hotmail.com
Additional Information:

Publications of Results:
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

Other Publications:
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
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
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.

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Responsible Party: Nancy Ahmed El Salmawy, Principal Investigator,, Cairo University
ClinicalTrials.gov Identifier: NCT03158155    
Other Study ID Numbers: CEBD-2017-5-101
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders