Pediatric ObesityPERIOBESITYNCT07086027
Dental and Periodontal Health in Obese Adolescents: Clinical, Biochemical, and Microbiological Evaluation
An observational study of Pediatric Obesity and Periodontal Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether obesity affects oral and gum health in children and adolescents. A total of 75 children aged 8 to 13 years participated, including both obese and non-obese individuals. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Periodontal Disease, Inflammation Biomarkers
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2017to 30 Aug 2018
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 75 adolescents aged 8 to 13 years were included in the study. Participants were divided into two groups: obese (BMI > 95th percentile) and normal-weight (BMI 5th-85th percentile). Both groups were evaluated for periodontal status, inflammatory biomarkers, and subgingival microbiota.
Who may be able to join
- Children aged between 8 and 13 years
- Parental consent obtained
- No systemic diseases other than obesity
- No current medication use
Who cannot join
- Use of antibiotics or anti-inflammatory drugs in the past 3 months
- History of systemic disease (other than obesity for the obese group)
- Undergoing orthodontic treatment
- Missing permanent first molars
- Uncooperative behavior during examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Biochemical, and Microbiological Evaluation of Dental and Periodontal Health in Obese Adolescents: A Cross-Sectional Study
This study aims to investigate whether obesity affects oral and gum health in children and adolescents. A total of 75 children aged 8 to 13 years participated, including both obese and non-obese individuals. All participants received a dental examination, and samples of saliva, blood, and gum fluid were collected to measure specific inflammation-related substances (such as IL-1α, IL-1β, and leptin). The presence of specific bacteria in the mouth was also analyzed.
Read the detailed description
This cross-sectional observational study aimed to investigate the relationship between pediatric obesity and periodontal health by integrating clinical, biochemical, and microbiological assessments. A total of 75 adolescents (36 obese and 39 non-obese), aged 8-13 years, were enrolled. Clinical oral evaluations included dft, DMFT, plaque index (PI), gingival index (GI), and probing depth (PD). Blood, saliva, and gingival crevicular fluid (GCF) samples were collected for ELISA-based measurement of pro-inflammatory biomarkers (IL-1α, IL-1β, and leptin). Subgingival plaque samples were analyzed using real-time PCR to quantify six key periodontal pathogens.
- Conditions
- Pediatric Obesity, Periodontal Disease, Inflammation Biomarkers, Dental Plaque, Dental Caries
- Medical subject headings
- Pediatric Obesity, Periodontal Diseases, Dental Plaque, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese Group | Adolescents aged 8-13 years with a body mass index (BMI) above the 95th percentile for age and sex, classified as obese. Participants underwent dental examination and provided saliva, serum, gingival crevicular fluid (GCF), and subgingival plaque samples for biomarker and microbiological analysis. | |
| Control Group (Normal Weight) | Adolescents aged 8-13 years with a BMI between the 5th and 85th percentiles for age and sex, considered to have normal weight. The same clinical and sample collection procedures were applied as in the obese group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary IL-1α Levels
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline (single time point, during sample collection visit)
Salivary IL-1β Levels
This outcome measures the concentration of interleukin-1 beta (IL-1β) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Salivary Leptin Levels
This outcome measures the concentration of leptin in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Serum IL-1α Levels
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Serum IL-1β Levels
This outcome measures the concentration of interleukin-1 beta (IL-1β) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Serum Leptin Levels
This outcome measures the concentration of leptin in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Gingival Crevicular Fluid (GCF) IL-1α Levels
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
GCF IL-1β Levels
This outcome measures the concentration of interleukin-1 beta (IL-1β) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
GCF Leptin Levels
This outcome measures the concentration of leptin in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Measured: At baseline
Body Mass Index (BMI)
Unit of Measure: kg/m²
Description:
BMI is calculated by dividing weight in kilograms by height in meters squared (kg/m²). Measurements will be used to classify participants as obese (BMI ≥ 95th percentile) or non-obese (BMI < 75th percentile) according to age- and sex-specific CDC growth charts. Higher BMI values indicate greater obesity severity.
Measured: at baseline
Secondary outcomes (12)
Presence of Porphyromonas gingivalis in Subgingival Plaque
Detection of P. gingivalis in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)
Measured: At baseline (single time point)
Presence of Treponema denticola in Subgingival Plaque
Detection of reponema denticola in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)
Measured: At baseline (during clinical examination)
Presence of Tannerella forsythia in Subgingival Plaque
Detection of Tannerella forsythia in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents. Unit of Measure: Presence/Absence (or Log genome equivalents if quantitative PCR used)
Measured: At baseline (during clinical examination)
Presence of Actinobacillus actinomycetemcomitans in Subgingival Plaque
Unit of Measure: Presence/absence (qualitative PCR)
Description:
Detection of A. actinomycetemcomitans in subgingival plaque samples using real-time PCR. Results will be compared between obese and non-obese adolescents.
Measured: At baseline
Presence of Prevotella intermedia in Subgingival Plaque
Unit of Measure: Presence/absence (qualitative PCR)
Description:
PCR-based detection of P. intermedia in subgingival plaque. Prevalence will be compared between obese and non-obese adolescents.
Measured: At baseline
Presence of Candida albicans in Subgingival Plaque
Unit of Measure: Presence/absence (qualitative PCR)
Description:
Identification of Candida albicans in subgingival plaque using real-time PCR and comparison of presence between obese and non-obese groups.
Measured: At baseline
Total Bacterial DNA in Subgingival Plaque
Unit of Measure: Log genome equivalents/sample (quantitative PCR)
Description:
Total bacterial DNA load in subgingival plaque will be quantified using real-time PCR and compared between obese and non-obese adolescents.
Measured: At baseline
Plaque Index (PI) Score
Unit of Measure: Index score (0-3 scale)
Description:
Plaque accumulation will be assessed using the Silness and Löe Plaque Index. Scores range from 0 (no plaque) to 3 (abundant plaque). Higher scores indicate worse oral hygiene.
Measured: At baseline (during clinical examination)
Gingival Index (GI) Score
Unit of Measure: Index score (0-3 scale)
Description:
Gingival inflammation will be evaluated using the Löe and Silness Gingival Index. Scores range from 0 (healthy) to 3 (severe inflammation). Higher scores indicate worse gingival health.
Measured: At baseline
Probing Depth (PD)
Unit of Measure: Millimeters (mm)
Description:
Probing depth will be measured at six sites per tooth using a Williams probe. Higher values indicate deeper periodontal pockets and worse periodontal condition.
Measured: At baseline
Bleeding on Probing (BOP)
Unit of Measure: Percentage of sites with bleeding (%)
Description:
The proportion of periodontal sites that bleed upon gentle probing will be recorded. Higher percentages indicate greater gingival inflammation.
Measured: at baseline
Dental Caries Experience (dft Index)
Unit of Measure: Number of affected teeth (dft score: 0 to 20)
Description:
The dft index (decayed and filled primary teeth) will be recorded to assess caries experience in the primary dentition. Scores range from 0 (no caries experience) to 20 (maximum caries experience in all primary teeth). Higher scores indicate worse dental health.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start10 Jun 2017
- Primary completion15 Jun 2018
- Study completion30 Aug 2018
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.
- More trials run by Marmara 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Çağla Kondoz Torun, DDS, Principal investigator, Marmara University Faculty of Dentistry Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086027
- Sponsor's protocol ID
- 2017-107
- Other IDs
- Ethics Committee
- Acronym
- PERIOBESITY
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) due to ethical and privacy considerations. The study was not designed with data sharing provisions, and participant consent for future data sharing was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical, and Microbiological Evaluation of Dental and Periodontal Health in Obese Adolescents: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07086027
- Acronym / sponsor ID
- PERIOBESITY / 2017-107
- Conditions
- Pediatric Obesity, Periodontal Disease, Inflammation Biomarkers, Dental Plaque, Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 25 Jul 2025 (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.
This study aims to investigate whether obesity affects oral and gum health in children and adolescents. A total of 75 children aged 8 to 13 years participated, including both obese and non-obese individuals. All participants received a dental examination, and samples of saliva, blood, and gum fluid were collected to measure specific inflammation-related substances (such as IL-1α, IL-1β, and leptin). The presence of specific bacteria in the mouth was also analyzed.
Detailed description
This cross-sectional observational study aimed to investigate the relationship between pediatric obesity and periodontal health by integrating clinical, biochemical, and microbiological assessments. A total of 75 adolescents (36 obese and 39 non-obese), aged 8-13 years, were enrolled. Clinical oral evaluations included dft, DMFT, plaque index (PI), gingival index (GI), and probing depth (PD). Blood, saliva, and gingival crevicular fluid (GCF) samples were collected for ELISA-based measurement of pro-inflammatory biomarkers (IL-1α, IL-1β, and leptin). Subgingival plaque samples were analyzed using real-time PCR to quantify six key periodontal pathogens.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Group | – | –Adolescents aged 8-13 years with a body mass index (BMI) above the 95th percentile for age and sex, classified as obese. Participants underwent dental examination and provided saliva, serum, gingival crevicular fluid (GCF), and subgingival plaque samples for biomarker and microbiological analysis. |
| Control Group (Normal Weight) | – | –Adolescents aged 8-13 years with a BMI between the 5th and 85th percentiles for age and sex, considered to have normal weight. The same clinical and sample collection procedures were applied as in the obese group. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 75 adolescents aged 8 to 13 years were included in the study. Participants were divided into two groups: obese (BMI > 95th percentile) and normal-weight (BMI 5th-85th percentile). Both groups were evaluated for periodontal status, inflammatory biomarkers, and subgingival microbiota.
Key inclusion criteria (4 listed)
- Children aged between 8 and 13 years
- Parental consent obtained
- No systemic diseases other than obesity
- No current medication use
Key exclusion criteria (5 listed)
- Use of antibiotics or anti-inflammatory drugs in the past 3 months
- History of systemic disease (other than obesity for the obese group)
- Undergoing orthodontic treatment
- Missing permanent first molars
- Uncooperative behavior during examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary IL-1α Levels
Time frame: At baseline (single time point, during sample collection visit)
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Salivary IL-1β Levels
Time frame: At baseline
This outcome measures the concentration of interleukin-1 beta (IL-1β) in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Salivary Leptin Levels
Time frame: At baseline
This outcome measures the concentration of leptin in unstimulated saliva and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Serum IL-1α Levels
Time frame: At baseline
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Serum IL-1β Levels
Time frame: At baseline
This outcome measures the concentration of interleukin-1 beta (IL-1β) in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Serum Leptin Levels
Time frame: At baseline
This outcome measures the concentration of leptin in serum samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Gingival Crevicular Fluid (GCF) IL-1α Levels
Time frame: At baseline
This outcome measures the concentration of interleukin-1 alpha (IL-1α) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
GCF IL-1β Levels
Time frame: At baseline
This outcome measures the concentration of interleukin-1 beta (IL-1β) in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
GCF Leptin Levels
Time frame: At baseline
This outcome measures the concentration of leptin in GCF samples and compares levels between obese and non-obese adolescents. Unit of Measure: pg/mL
Body Mass Index (BMI)
Time frame: at baseline
Unit of Measure: kg/m² Description: BMI is calculated by dividing weight in kilograms by height in meters squared (kg/m²). Measurements will be used to classify participants as obese (BMI ≥ 95th percentile) or non-obese (BMI < 75th percentile) according to age- and sex-specific CDC growth charts. Higher BMI values indicate greater obesity severity.
12 secondary outcomes
Presence of Porphyromonas gingivalis in Subgingival Plaque
Time frame: At baseline (single time point)
Presence of Treponema denticola in Subgingival Plaque
Time frame: At baseline (during clinical examination)
Presence of Tannerella forsythia in Subgingival Plaque
Time frame: At baseline (during clinical examination)
Presence of Actinobacillus actinomycetemcomitans in Subgingival Plaque
Time frame: At baseline
Presence of Prevotella intermedia in Subgingival Plaque
Time frame: At baseline
Presence of Candida albicans in Subgingival Plaque
Time frame: At baseline
Total Bacterial DNA in Subgingival Plaque
Time frame: At baseline
Plaque Index (PI) Score
Time frame: At baseline (during clinical examination)
Gingival Index (GI) Score
Time frame: At baseline
Probing Depth (PD)
Time frame: At baseline
Bleeding on Probing (BOP)
Time frame: at baseline
Dental Caries Experience (dft Index)
Time frame: At baseline
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 25 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) due to ethical and privacy considerations. The study was not designed with data sharing provisions, and participant consent for future data sharing was not obtained.
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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.
Çağla Kondoz Torun, DDS principal investigator
Marmara University Faculty of Dentistry Department of Pediatric Dentistry
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 Pediatric Obesity and Periodontal Disease, run by Marmara 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 4 inclusion and 5 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 25 Jul 2025. 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?
Salivary IL-1α Levels (time frame: At baseline (single time point, during sample collection visit)). The study lists 10 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 25 Jul 2025.