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

June 5, 2017 updated by: Nancy Ahmed El Salmawy
To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed tooth formation and eruption
Time Frame: 6 months
  • Delayed tooth eruption.
  • Tooth smaller than normal
6 months
Gingivitis
Time Frame: 6 months
binary yes or no
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nancy Ahmed El Salmawy

Investigators

  • Study Director: Nourhan A. El dokky, A. Professor, neldokky@hotmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 15, 2017

Primary Completion (ANTICIPATED)

July 15, 2018

Study Completion (ANTICIPATED)

July 18, 2018

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (ACTUAL)

May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-2017-5-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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