Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis

NCT07607639 | Recruiting

• 1 other identifier: NigdeOHU-GingivitisDOS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels. Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (4)

• Gingival crevicular fluid TNF-α levels

  Baseline

• Gingival crevicular fluid IL-1β levels

  Baseline

• Gingival crevicular fluid IL-10 levels

  Baseline

• Gingival crevicular fluid MMP-8 levels

  Baseline

Secondary Outcomes (4)

• Gingival Index

  Baseline

• Plaque Index

  Baseline

• Bleeding on Probing Scores Assessed by Periodontal Probing

  Baseline

• Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe

  Baseline

Study Arms (2)

Childhood gingivitis group

Systemically healthy children aged 8-12 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.

Diagnostic Test: Gingival Crevicular Fluid Biomarker Assessment

Young adult gingivitis group

Systemically healthy young adults aged 15-24 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.

Diagnostic Test: Gingival Crevicular Fluid Biomarker Assessment

Interventions

Gingival Crevicular Fluid Biomarker Assessment DIAGNOSTIC_TEST

Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only.

Childhood gingivitis group; Young adult gingivitis group

Eligibility Criteria

• Age: 8 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Pedodontics and Periodontology Clinics of Niğde Ömer Halisdemir University Faculty of Dentistry. The study population will consist of systemically healthy children and young adults diagnosed with gingivitis. Participants will be divided into two age-based groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to being in a transitional pubertal stage associated with significant hormonal variability that may influence gingival inflammatory responses and confound biomarker levels. All participants will undergo clinical periodontal examination and gingival crevicular fluid sampling for biomarker analysis.

You may qualify if:

• Individuals aged 8-12 years (child group) or 15-24 years (young adult group)
• Clinical diagnosis of gingivitis
• Presence of fully erupted tooth #31 with closed apex
• Systemically healthy individuals
• No history of periodontal treatment in the last 3 months
• No antibiotic or anti-inflammatory drug use in the last 3 months
• Good cooperation and willingness to participate
• Written informed consent from participants or legal guardians (for minors)

You may not qualify if:

• Age 13-14 years (transitional pubertal period)
• Presence of periodontitis or other periodontal diseases
• Systemic, genetic, or immunological diseases
• Acute oral infections or conditions requiring emergency treatment
• Orthodontic appliances in the sampling region
• Smokers
• Pregnant or lactating individuals
• Individuals with cognitive, psychological, or physical disabilities affecting cooperation
• Inadequate eruption or incomplete root development of tooth #31
• Refusal to participate or withdrawal of consent

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, 51240, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid (GCF) samples will be collected using sterile absorbent paper strips from tooth #31 and stored at -80°C until biomarker analysis. Levels of IL-1β, TNF-α, IL-10, and MMP-8 will be evaluated using ELISA.

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Aycan Dal Dönertaş

CONTACT

+903382252595; aycandal@outlook.com

Selcen Özcan Bulut

CONTACT

selcen_ozcan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Locations

TU (1)