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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Body Mass Index, Dental Caries, Eruption
- 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.
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.
- First posted15 Jun 2023
- Study start21 Apr 2021
- Primary completion21 Jun 2023 (estimated)
- Study completion21 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Mass IndexStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ibrahim Ahmed Hammad, Al-Azhar University
- Investigators
- Alaa Nabil Abbas, PHD, Study chair, Al-Azhar University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Body Mass Index, Dental Eruption and Dental Caries Prevalence in School Children: A Cross-sectional, Observational Study
- ClinicalTrials.gov ID
- NCT05902611
- Acronym / sponsor ID
- 635/3505
- Conditions
- Body Mass Index, Dental Caries, Eruption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,224 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 15 Jun 2023 (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 aim of the current study will be to explore the relationship between body mass index, dental eruption and dental caries prevalence in school Children.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Parents and patients, acceptance and cooperation.
- children between 6 and 9 years of age.
Key exclusion criteria (2 listed)
- Uncooperative child.
- Children with systemic disease that can affect their cooperation.
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 |
|---|---|---|
| BMI determination, Eruption Time Assessment, Caries AssessmentBMI determination, Eruption Time Assessment, Caries Assessment | Behavioural | – |
Primary outcome
Body Mass Index using this equation: weight in kilograms divided by the square of height in meters
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 19958253Sanchez-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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alaa Nabil Abbas, PHD study chair
Al-Azhar 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 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.