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

Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis

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.

Study Overview

• Status: Recruiting
• Conditions: Gingivitis
• Intervention / Treatment: Diagnostic test: Gingival Crevicular Fluid Biomarker Assessment

Detailed Description

Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity.

This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. 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 due to pubertal hormonal variability that may affect inflammatory biomarker levels.

Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA.

The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Aycan Dal Dönertaş; Phone Number: +903382252595; Email: aycandal@outlook.com
• Study Contact Backup: Name: Selcen Özcan Bulut; Email: selcen_ozcan@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Niğde, Turkey (Türkiye), 51240
    • Recruiting
    • Niğde Ömer Halisdemir University Faculty of Dentistry
    • Contact: Merdan Doğan; Phone Number: 905422076565; Email: merdan@ohu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index	Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3: 0 = normal gingiva; = mild inflammation; = moderate inflammation with bleeding on probing; = severe inflammation with spontaneous bleeding Higher scores indicate worse gingival inflammation.	Baseline
Plaque Index	Dental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3: 0 = no plaque; = plaque detectable by probe; = visible plaque accumulation; = abundant plaque accumulation Higher scores indicate poorer oral hygiene and greater plaque accumulation.	Baseline
Bleeding on Probing Scores Assessed by Periodontal Probing	Bleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously: 0 = absence of bleeding 1 = presence of bleeding Higher scores indicate greater gingival inflammation.	Baseline
Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe	Periodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth. Higher values indicate deeper periodontal pockets and worse periodontal condition.	Baseline

Collaborators and Investigators

• Sponsor: Nigde Omer Halisdemir University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis
• Other Study ID Numbers: NigdeOHU-GingivitisDOS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No