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Body Mass IndexNCT05902611

The Relationship Between Body Mass Index, Dental Eruption and Dental Caries Prevalence in School Children

An observational study of Body Mass Index and Dental Caries, run by Al-Azhar University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the current study will be to explore the relationship between body mass index, dental eruption and dental caries prevalence in school Children. Read more about this study

Who is it for?
Ages 6 to 9 years
Conditions the study is for
Body Mass Index, Dental Caries, Eruption
What is being tested?
BMI determination, Eruption Time Assessment, Caries Assessment
How many people
1,224 participants
Where
1 siteEgypt
Study dates
21 Apr 2021to 21 Sep 2023
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 6 to 9 years
  • All sexes
  • Child

Study population: The aim of this study is to find out the relationship between body mass index, dental eruption and dental caries in children aged 6 to 9 years, based on the previous study by Anu 2020 (15) who reported a correlation of -0.08 between body mass index and eruption status of permanent mandibular molar; a total sample size of 1224 will be sufficient with power 80 % and 5% significant level. The sample size was calculated by PASS 2008.

Who may be able to join

  • Parents and patients, acceptance and cooperation.
  • children between 6 and 9 years of age.

Who cannot join

  • Uncooperative child.
  • Children with systemic disease that can affect their cooperation.

Trial locations and contacts

1 site in 1 country.

Mohamed Ahmed Hammad, Master contact

201061413777

sword_fish33@yahoo.com

Egypt1 site, 1 recruiting
  • AlAzhar university

    Cairo

    Recruiting

Other trials in Egypt

About this study

Official title: The Relationship Between Body Mass Index, Dental Eruption and Dental Caries Prevalence in School Children: A Cross-sectional, Observational Study

The aim of the current study will be to explore the relationship between body mass index, dental eruption and dental caries prevalence in school Children.

Read the detailed description

Obesity is an abnormal accumulation of body fat. This accumulation of extra fat within the body may have either environmental or genetic causes . Obese children and adolescents are at increased risk for developing diabetes, metabolic problems, high blood pressure hypertension, coronary artery disease, sleep apnea, orthopedic problems, and psychosocial disorders.

Body mass index is the definition of obesity for children and adolescents. It is a formula that considers an individual's height and weight to determine body fat and health risk. For children it is calculated by this formula: weight ÷ (height x height).

For children and teens, BMI is age- and sex-specific and is often referred to as BMI-for-age. A child's weight status is determined using an age- and sex-specific percentile for BMI rather than the BMI categories used for adults. This is because children's body composition varies as they age and varies between boys and girls. Therefore, BMI levels among children and teens need to be expressed relative to other children of the same age and sex.

Obesity and dental caries are multifactorial conditions, both having comprehensive etiology and factors such as dietary habits and available nutrients, oral hygiene, or saliva . Changes in diet and lifestyle, such as an increase in wealth and access to carbohydrate-rich, high-calorie food and drinks could be attributed to the increase in the prevalence of both dental caries and obesity.

Several studies have evaluated the relationship between tooth decay and obesity; however, results are sometimes contradictory but recent studies showed that underweight children may experience higher dental caries than normal weight and overweight children.

Dental eruption is the emergence of the tooth into the oral cavity from its position in the alveolar crypt, and this process is influenced by genetic, systemic, general and local factors. It is positively related to the somatic growth (height and weight) of an individual.

Many studies worldwide describe how poor nutrition during the growth period adversely influences aspects of dental development, including delaying the eruption of deciduous and permanent teeth in underweight children than normal and overweight children. Postnatal growth and nutritional status have been linked to the eruption of primary teeth however; the studies assessing the association of obesity and permanent tooth development are few.

This complicated relation between oral health and body composition must be taken into consideration when treating children, hence the aim of this study is to identify if there is any relationship between dental caries and dental eruption with body mass index.

Being tested
BMI determination, Eruption Time Assessment, Caries Assessment
Medical subject headings
Dental Caries, Exanthema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMI determination, Eruption Time Assessment, Caries AssessmentBehavioural

    BMI determination, Eruption Time Assessment, Caries Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index using this equation: weight in kilograms divided by the square of height in meters

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start21 Apr 2021
  3. Primary completion21 Jun 2023 (estimated)
  4. Study completion21 Sep 2023 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
1,224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902611
Sponsor's protocol ID
635/3505
Status last verified
Jun 2023
First submitted
3 Jun 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanchez-Perez L, Irigoyen ME, Zepeda M. Dental caries, tooth eruption timing and obesity: a longitudinal study in a group of Mexican schoolchildren. Acta Odontol Scand. 2010 Jan;68(1):57-64. doi: 10.3109/00016350903449367.

    PubMed 19958253

Questions about this trial

What is this clinical trial studying?

An observational study of Body Mass Index and Dental Caries, run by Al-Azhar 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 2 inclusion and 2 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 15 Jun 2023. 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 Mohamed Ahmed Hammad, Master (201061413777, sword_fish33@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index using this equation: weight in kilograms divided by the square of height in meters (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902611, which also lists 1 linked publication.

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 15 Jun 2023.

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