Study Focus on the Effect of Malnutrition and Dental ProblemNCT04747028
Effect of Malnutrition on Primary and Permanent Dentation
An observational study of Study Focus on the Effect of Malnutrition and Dental Problem, run by Cairo University.
Trial summary
The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Study Focus on the Effect of Malnutrition and Dental Problem
- What is being tested?
- Dmf score
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jun 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 4 to 16 years
- All sexes
- Child
Study population: Children and adolescent diagnosed with malnutrition in the past or presnt time.patient should not suffer from any other systemic disease
Who may be able to join
- parent accept to sign the informed consent Participants not suffering from any other systematic disease
Who cannot join
- non coopreative patient Suffering from systematic disease
About this study
Official title: Effect of Malnutrition on Primary and Permanent Dentition a Cross Sectional Study
The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants
Read the detailed description
The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel
- Being tested
- Dmf score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dmf scoreDiagnostic test
A chart to calculate the caries index
| Study group | Role | What they receive |
|---|---|---|
| Primary dentition | Children from 4 to 6 years old suffering from malnutrition Receives: Diagnostic Test: Dmf score | |
| Age 13 to 16 | Adolecentsfrom 13 to 16 suffering from malnutrition at present time or during their childhood Receives: Diagnostic Test: Dmf score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries index
Score obtained from DMF index
Measured: 1month
Secondary outcomes (1)
E amel malformation
Modified DDE index
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Focus on the Effect of Malnutrition and Dental ProblemStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina mounir elkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747028
- Sponsor's protocol ID
- 66789
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Malnutrition on Primary and Permanent Dentition a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04747028
- Acronym / sponsor ID
- 66789
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Feb 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 caries index delayed eruption and enamel malformation will recorded for a 2 group of participants
Detailed description
The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary dentition | – | Diagnostic Test: Dmf scoreChildren from 4 to 6 years old suffering from malnutrition |
| Age 13 to 16 | – | Diagnostic Test: Dmf scoreAdolecentsfrom 13 to 16 suffering from malnutrition at present time or during their childhood |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and adolescent diagnosed with malnutrition in the past or presnt time.patient should not suffer from any other systemic disease
Key inclusion criteria (1 listed)
- parent accept to sign the informed consent Participants not suffering from any other systematic disease
Key exclusion criteria (1 listed)
- non coopreative patient Suffering from systematic disease
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 |
|---|---|---|
| Dmf scoreA chart to calculate the caries index | Diagnostic test | Age 13 to 16, Primary dentition |
Primary outcome
Caries index
Time frame: 1month
Score obtained from DMF index
1 secondary outcome
E amel malformation
Time frame: 1month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Study Focus on the Effect of Malnutrition and Dental Problem, run by Cairo University.
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 1 inclusion and 1 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries index (time frame: 1month). 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 10 Feb 2021.