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Completed

NCT Number: NCT07086027

Dental and Periodontal Health in Obese Adolescents: Clinical, Biochemical, and Microbiological Evaluation

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.

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Key information

Conditions

Pediatric Obesity Body Weight Dental Caries Dental Deposits Dental Plaque Inflammation Biomarkers Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Periodontal Disease Periodontal Diseases Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged between 8 and 13 years

Parental consent obtained

No systemic diseases other than obesity

No current medication use

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

Secondary outcomes

  1. Presence of Porphyromonas gingivalis in Subgingival Plaque

    Time frame: At baseline (single time point)

    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)

  2. Presence of Treponema denticola in Subgingival Plaque

    Time frame: At baseline (during clinical examination)

    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)

  3. Presence of Tannerella forsythia in Subgingival Plaque

    Time frame: At baseline (during clinical examination)

    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)

  4. Presence of Actinobacillus actinomycetemcomitans in Subgingival Plaque

    Time frame: At baseline

    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.

  5. Presence of Prevotella intermedia in Subgingival Plaque

    Time frame: At baseline

    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.

  6. Presence of Candida albicans in Subgingival Plaque

    Time frame: At baseline

    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.

  7. Total Bacterial DNA in Subgingival Plaque

    Time frame: At baseline

    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.

  8. Plaque Index (PI) Score

    Time frame: At baseline (during clinical examination)

    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.

  9. Gingival Index (GI) Score

    Time frame: At baseline

    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.

  10. Probing Depth (PD)

    Time frame: At baseline

    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.

  11. Bleeding on Probing (BOP)

    Time frame: at baseline

    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.

  12. Dental Caries Experience (dft Index)

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Clinical, Biochemical, and Microbiological Evaluation of Dental and Periodontal Health in Obese Adolescents: A Cross-Sectional Study

Acronym: PERIOBESITY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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