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

ConditionGingivitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-24
SponsorNigde Omer Halisdemir University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Childhood gingivitis group1 intervention
Group B: Young adult gingivitis group1 intervention

Trial outcomes

Primary outcomes

1

Gingival crevicular fluid TNF-α levels

Time frame
Baseline
2

Gingival crevicular fluid IL-1β levels

Time frame
Baseline
3

Gingival crevicular fluid IL-10 levels

Time frame
Baseline
4

Gingival crevicular fluid MMP-8 levels

Time frame
Baseline

Secondary outcomes

1

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 1. = mild inflammation 2. = moderate inflammation with bleeding on probing 3. = severe inflammation with spontaneous bleeding Higher scores indicate worse gingival inflammation.

Time frame
Baseline
2

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 1. = plaque detectable by probe 2. = visible plaque accumulation 3. = abundant plaque accumulation Higher scores indicate poorer oral hygiene and greater plaque accumulation.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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