NCT04774653

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 19, 2021

Last Update Submit

February 24, 2021

Conditions

Keywords

MIHHSPMStunded childrenPrevalence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HSPM in stunted children

    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).

    6 Months from April to October 2021

Secondary Outcomes (1)

  • Prevalence of MIH in stunted children

    6 Months ( from April to October 2021)

Other Outcomes (1)

  • Association of MIH &HSPM with short stature

    6 Months ( from April to October 2021)

Study Arms (3)

MIH Group in short stature from 6-8 years old

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

Other: No intervention

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

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

Interventions

Associations and prevalence will be calculated

Both MIH &HSPM Group in stunted (from 5-8) years oldHSPM Group in short stature from 5-8 years oldMIH Group in short stature from 6-8 years old

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Egyptian children aged from 5 to 8 years with short stature attending to Outpatient Clinic of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.

You may qualify if:

  • 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)

You may not qualify if:

  • Children with extracted primary second molars and permanent incisors and molars.
  • Children with history of dental trauma.
  • Children with orthodontic bands or dental appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, 0022, Egypt

RECRUITING

MeSH Terms

Conditions

DwarfismMolar HypomineralizationDental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital Abnormalities

Study Officials

  • Rania Nasr, Assoc. Prof.

    Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania Nasr, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr. Rania Nasr

Study Record Dates

First Submitted

February 19, 2021

First Posted

March 1, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations