Short StatureNCT04774653
Hypo-mineralization of Primary and Permanent Teeth in a Group of Children With Stunted Growth.A Cross Sectional Study.
An observational study of Short Stature and Hypomineralization Molar Incisor, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Short Stature, Hypomineralization Molar Incisor, Hypomineralization of Enamel
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- • 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)
Who cannot join
- • Children with extracted primary second molars and permanent incisors and molars.
- Children with history of dental trauma.
- Children with orthodontic bands or dental appliances.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo, 0022
Rania Nasr, Assoc. Prof.
About this study
Official title: Hypo-mineralization of Primary and Permanent Teeth in a Group of Children With Stunted Growth. A Cross Sectional Study.
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.
Read more
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).
Read the 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.
- Being tested
- No intervention
- Keywords
- MIH, HSPM, Stunded children, Prevalence
- Medical subject headings
- Dwarfism, Molar Hypomineralization, Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Associations and prevalence will be calculated
| Study group | Role | What they receive |
|---|---|---|
| MIH Group in short stature from 6-8 years old | Molar Incisor Hypomineralization in stunted children aged from 6-8 years Receives: 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 Receives: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 Months from April to October 2021
Secondary outcomes (1)
Prevalence of MIH 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).
Measured: 6 Months ( from April to October 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Dr. Rania Abdallah Nasr, Cairo University
- Investigators
- Rania Nasr, Assoc. Prof., Principal investigator, Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774653
- Sponsor's protocol ID
- 00022021
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Informed consent Patient Diagnostic Chart Statistical Analysis
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo-mineralization of Primary and Permanent Teeth in a Group of Children With Stunted Growth. A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT04774653
- Acronym / sponsor ID
- 00022021
- Keywords
- MIH, HSPM, Stunded children, Prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIH Group in short stature from 6-8 years old | – | Other: No interventionMolar Incisor Hypomineralization in stunted children aged from 6-8 years |
| HSPM Group in short stature from 5-8 years old | – | Other: No interventionHypomineralization of Second Primary Molars in stunted children aged from 5-8 years |
| Both MIH &HSPM Group in stunted (from 5-8) years old | – | Other: No interventionWhen 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 |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- • Children aged from 5 to 8 years.
Key exclusion criteria (3 listed)
- • Children with extracted primary second molars and permanent incisors and molars.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAssociations and prevalence will be calculated | Other | Both MIH &HSPM Group in stunted (from 5-8) years old, HSPM Group in short stature from 5-8 years old, MIH Group in short stature from 6-8 years old |
Primary outcome
Prevalence of HSPM in stunted children
Time frame: 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).
1 secondary outcome
Prevalence of MIH in stunted children
Time frame: 6 Months ( from April to October 2021)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided. Informed consent Patient Diagnostic Chart Statistical Analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Nasr, Assoc. Prof. principal investigator
Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Stature and Hypomineralization Molar Incisor, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Nasr, Assoc. Prof. (0020/ 01005037367, nasrania05@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HSPM in stunted children (time frame: 6 Months from April to October 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.