Pediatric ObesityNCT06283602
Oral Health in Children and Adolescents With Obesity and Normal Weight
A study testing oral health status in people with Pediatric Obesity and Pediatric Dentistry, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents. 82 participants aged 6-16 years were concluded in this cross-sectional study. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pediatric Obesity, Pediatric Dentistry
- What is being tested?
- oral health status
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 29 Apr 2021
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Infection,
- diabetes, leukemia, asthma, bronchitis, cognitive neuromotor disorder, hormonal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erosive Tooth Wear, Caries Experience and Periodontal Health in Children and Adolescents With Obesity and Normal Weight
We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.
82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD).
Read the detailed description
Also, the relationship between procalcitonin (PCT), C-reactive protein (CRP), parathormone (PTH), and 25(OH)D blood biochemistry and oral health was evaluated in obese children/adolescents.
- Conditions
- Pediatric Obesity, Pediatric Dentistry
- Being tested
- oral health status
- Keywords
- dental caries, periodontal health, children, obesity, erosive tooth wear
- Medical subject headings
- Pediatric Obesity, Dental Caries, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral health statusDiagnostic test
the dentists examined the dried teeth with a probe and mount mirror in a dental unit.
| Study group | Role | What they receive |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Patient who apply to our clinic for routine paediatric treatment for the included in the study Receives: Diagnostic Test: oral health status |
What is being measured
The primary outcome is the main question the study is designed to answer.
the results of DMFT, plaque and gingival indies
The results of the study indicate that individuals with obesity tend to exhibit significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight t significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight (p<0.05)
Measured: 12 months
the results of dmft, BEWE, ICDAS-II, probing dept
No significant difference was observed concerning dmft and other factors (p>0.05)
Measured: up to 12 months
Comparison of demographic attributes between obese and normal weights
Significant disparities were identified between patients with normal weight and those who were obese, particularly in BMI, income, and tooth brushing habits. Obese patients exhibited considerably higher BMI scores in comparison to those with normal weight (p<0.001).Body mass index (BMIs; kg/m2) was calculated by the pediatrician using the patients' height (meters) and weight (kilograms). BMI 5-85th percentile normal weight according to gender and age; BMI 85- 95 percentile overweight; Those at the 95th percentile and above were considered obese
Measured: 12 months
Secondary outcomes (2)
biochemical parameters of obese individuals
Procalcitonin exhibited significantly negative correlation between DMFT and ICDAS-II (p<0.05).
Measured: 11 months
other biochemical parameters of obese individuals
No significant correlation was found between the biomarkers and other investigated factors (p>0.05)
Measured: up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2020
- Primary completion5 Mar 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Sogukpınar, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283602
- Sponsor's protocol ID
- 2020/17
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erosive Tooth Wear, Caries Experience and Periodontal Health in Children and Adolescents With Obesity and Normal Weight
- ClinicalTrials.gov ID
- NCT06283602
- Acronym / sponsor ID
- 2020/17
- Conditions
- Pediatric Obesity, Pediatric Dentistry
- Keywords
- dental caries, periodontal health, children, obesity, erosive tooth wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 28 Feb 2024 (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.
We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.
82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD).
Detailed description
Also, the relationship between procalcitonin (PCT), C-reactive protein (CRP), parathormone (PTH), and 25(OH)D blood biochemistry and oral health was evaluated in obese children/adolescents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Diagnostic Test: oral health statusPatient who apply to our clinic for routine paediatric treatment for the included in the study |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Infection,
- diabetes, leukemia, asthma, bronchitis, cognitive neuromotor disorder, hormonal 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 |
|---|---|---|
| oral health statusthe dentists examined the dried teeth with a probe and mount mirror in a dental unit. | Diagnostic test | Kahramanmaraş Sütçü İmam University |
Primary outcome
the results of DMFT, plaque and gingival indies
Time frame: 12 months
The results of the study indicate that individuals with obesity tend to exhibit significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight t significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight (p<0.05)
the results of dmft, BEWE, ICDAS-II, probing dept
Time frame: up to 12 months
No significant difference was observed concerning dmft and other factors (p>0.05)
Comparison of demographic attributes between obese and normal weights
Time frame: 12 months
Significant disparities were identified between patients with normal weight and those who were obese, particularly in BMI, income, and tooth brushing habits. Obese patients exhibited considerably higher BMI scores in comparison to those with normal weight (p<0.001).Body mass index (BMIs; kg/m2) was calculated by the pediatrician using the patients' height (meters) and weight (kilograms). BMI 5-85th percentile normal weight according to gender and age; BMI 85- 95 percentile overweight; Those at the 95th percentile and above were considered obese
2 secondary outcomes
biochemical parameters of obese individuals
Time frame: 11 months
other biochemical parameters of obese individuals
Time frame: up to 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral health status in people with Pediatric Obesity and Pediatric Dentistry, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 0 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the results of DMFT, plaque and gingival indies (time frame: 12 months). The study lists 3 primary outcomes in all. 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 28 Feb 2024.