An observational study in Gingivitis, sponsored by Nigde Omer Halisdemir University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Nigde Omer Halisdemir University · Observational
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.
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 80 is below the median of 93 across 116 observational studies indexed under Gingivitis.
Browse Gingivitis studies →Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Gingival crevicular fluid TNF-α levels
Time frame: Baseline
Gingival crevicular fluid IL-1β levels
Time frame: Baseline
Gingival crevicular fluid IL-10 levels
Time frame: Baseline
Gingival crevicular fluid MMP-8 levels
Time frame: Baseline
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
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
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
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
Started May 2026 (actual). Primary completion is estimated for Oct 2027, 17 months after the start.
Of 30 non-industry observational studies under Gingivitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 17 months is above that.
Counting every sponsor, half of 30 studies reached it within 12 months; a quarter within 5 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
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Nigde Omer Halisdemir University