Hypo-mineralization of Primary and Permanent Teeth in a Group of Children With Stunted Growth.A Cross Sectional Study.

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04774653
Collaborator
(none)
60
1
8
7.5

Study Details

Study Description

Brief Summary

The second primary molar (SPM) development start at the same time as development of the first permanent molars (FPM) and permanent incisors so any systemic disturbance - causing stunted growth -occur , will result in hypo-mineralization of SPM as well as FPM and permanent incisors (Butler 1967, Weerheijm and Mejàre 2003).

The literature shows no previous studies that discuss the association between hypo- mineralized second primary molar (HSPM), MIH and the stunted growth in children.

aim: Estimate Prevalence of HSPM and MIH in stunted children.Evaluate the association between HSPM, MIH and the stunted growth in a group of Egyptian children.

• The diagnostic criteria for MIH established based on the European Academy of Pediatric Dentistry criteria (Weerheijm and Mejàre 2003) while diagnostic criteria for HSPM was established by (Elfrink et al. 2008).

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

The second primary molar (SPM) development start at the same time as development of the first permanent molars (FPM) and permanent incisors so any systemic disturbance - causing stunted growth -occur , will result in hypo-mineralization of SPM as well as FPM and permanent incisors (Butler 1967, Weerheijm and Mejàre 2003).

The literature shows no previous studies that discuss the association between hypo- mineralized second primary molar (HSPM), MIH and the stunted growth in children.

aim: Estimate Prevalence of HSPM and MIH in stunted children.Evaluate the association between HSPM, MIH and the stunted growth in a group of Egyptian children.

. Methods of selection:

  • Stunted children aged from 5 to 8 years attending outpatient clinic in Pediatric Dentistry Department, Faculty of Dentistry, Cairo University will be included in this study according to eligibility criteria.

  • Informed consent will be obtained from children parents or guardians accepting to participate in the study. Medical and sociodemographic data will be recorded in patient chart.

  • Children will be examined clinically on dental units using artificial light. Wet cotton swabs will be used to prior to examination to remove excess plaque or saliva.

  • The diagnostic criteria for MIH established based on the European Academy of Pediatric Dentistry criteria (Weerheijm and Mejàre 2003) while diagnostic criteria for HSPM was established by (Elfrink et al. 2008).

Data sources and management:

Data will be obtained through clinical examination on participant children for MIH and HSPM according to the diagnosis criteria that we selected and the result will be collected in form of percentage for both conditions and the data will be analysis to show the relation between those conditions.

Handling of numerical/ quantitative variables:

Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro- Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values. If the assumption of normality was found to be violated, the data will be presented as median and range values.

Handling of categorical/ qualitative variables:

Categorical data will be represented as frequency (n) and percentage (%).

Statistical analysis:

Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be explored for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed, it will be presented as mean and standard deviation values and independent t-test will be used for the analysis. The significance level will be set at P ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Hypo-mineralization of Primary and Permanent Teeth in a Group of Children With Stunted Growth. A Cross Sectional Study.
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
MIH Group in short stature from 6-8 years old

Molar Incisor Hypomineralization in stunted children aged from 6-8 years

Other: No intervention
Associations and prevalence will be calculated

HSPM Group in short stature from 5-8 years old

Hypomineralization of Second Primary Molars in stunted children aged from 5-8 years

Other: No intervention
Associations and prevalence will be calculated

Both MIH &HSPM Group in stunted (from 5-8) years old

When both primary molars and permanent teeth( First permanent molars & permanent incisors) are hypo-mineralized in children with short stature with age range from 5-8 years old

Other: No intervention
Associations and prevalence will be calculated

Outcome Measures

Primary Outcome Measures

  1. Prevalence of HSPM in stunted children [6 Months from April to October 2021]

    Clinical examination (Weerheijm & Mejàre, 2003) Length /Height for age WHO growth charts (WHO, Length/Height for age Boys and Girls Available., www.who.int/childgrowth (2017).

Secondary Outcome Measures

  1. Prevalence of MIH in stunted children [6 Months ( from April to October 2021)]

    Clinical examination (Weerheijm & Mejàre, 2003) Length /Height for age WHO growth charts (WHO, Length/Height for age Boys and Girls Available., www.who.int/childgrowth (2017).

Other Outcome Measures

  1. Association of MIH &HSPM with short stature [6 Months ( from April to October 2021)]

    Is there an Association between HSPM, MIH and stunted growth in a group of Egyptian children?

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Children aged from 5 to 8 years.

  • Both genders.

  • Stunted growth (Stunting: when the height for age is less than the mean by two standard deviations of the WHO Child Standards for growth or less than the 5th centile for age)

Exclusion Criteria:
  • • Children with extracted primary second molars and permanent incisors and molars.

  • Children with history of dental trauma.

  • Children with orthodontic bands or dental appliances.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University Cairo Egypt 0022

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Rania Nasr, Assoc. Prof., Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Associate Professor Dr. Rania Abdallah Nasr, Associate Professor Dr. Rania Nasr, Cairo University
ClinicalTrials.gov Identifier:
NCT04774653
Other Study ID Numbers:
  • 00022021
First Posted:
Mar 1, 2021
Last Update Posted:
Mar 1, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Associate Professor Dr. Rania Abdallah Nasr, Associate Professor Dr. Rania Nasr, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2021