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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Gingival Crevicular Fluid Biomarker Assessment
Diagnostic testGingival 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
Trial outcomes
Primary outcomes
Gingival crevicular fluid TNF-α levels
Gingival crevicular fluid IL-1β levels
Gingival crevicular fluid IL-10 levels
Gingival crevicular fluid MMP-8 levels
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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