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Clinical Trials/NCT07086027
NCT07086027CompletedNot Applicable

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

Marmara University1 site in 1 country75 target enrollmentStarted: June 10, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
Salivary IL-1α Levels

Study Overview

Brief 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. 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

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
8 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Presence of Porphyromonas gingivalis in Subgingival Plaque(At baseline (single time point))
  • Presence of Treponema denticola in Subgingival Plaque(At baseline (during clinical examination))
  • Presence of Tannerella forsythia in Subgingival Plaque(At baseline (during clinical examination))
  • Presence of Actinobacillus actinomycetemcomitans in Subgingival Plaque(At baseline)
  • Presence of Prevotella intermedia in Subgingival Plaque(At baseline)
  • Presence of Candida albicans in Subgingival Plaque(At baseline)
  • Gingival Index (GI) Score(At baseline)
  • Total Bacterial DNA in Subgingival Plaque(At baseline)
  • Bleeding on Probing (BOP)(at baseline)
  • Dental Caries Experience (dft Index)(At baseline)
  • Plaque Index (PI) Score(At baseline (during clinical examination))
  • Probing Depth (PD)(At baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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