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OpenTrials
Completed

NCT Number: NCT07375719

Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

Diabetes mellitus and periodontitis are two highly prevalent chronic diseases with a well-established bidirectional relationship. Poor glycemic control has been associated with increased periodontal inflammation and disease progression, while periodontal disease may adversely affect metabolic control in individuals with diabetes. Gingival epithelial cells, characterized by a high turnover rate, may reflect early nuclear and cellular alterations related to chronic inflammatory and metabolic conditions.

The purpose of this cross-sectional observational study is to evaluate the association between glycemic control status, determined by hemoglobin A1c (HbA1c) levels, and nuclear morphological alterations in exfoliated gingival epithelial cells in patients with diabetes mellitus presenting with different severities of periodontal disease. Nuclear biomarkers, including micronuclei formation, binucleated cells, nuclear-to-cytoplasmic (N/C) ratio alterations, and perinuclear halo formation, are assessed using cytological analysis.

Additionally, the study aims to investigate the combined and independent effects of periodontal disease severity and glycemic control on nuclear structural changes in gingival epithelial cells, comparing individuals with good (HbA1c <7%) and poor (HbA1c ≥7%) glycemic control across different periodontal stages. This study seeks to contribute to the understanding of cellular-level alterations associated with chronic periodontal inflammation and metabolic dysregulation.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Çankırı Karatekin Üniversitesi

Çankırı, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 40 years
  • Diagnosis of periodontitis according to the 2018 periodontal classification
  • Absence of systemic diseases other than diabetes mellitus

Exclusion criteria

  • Presence of oral mucosal lesions
  • History of malignancy
  • Receipt of periodontal therapy within the previous 6 months
  • Pregnancy or lactation
  • Current or former tobacco use
  • Alcohol consumption
  • Known anemia
  • Vitamin B12 deficiency
  • Folate deficiency
  • Presence of systemic diseases (other than diabetes mellitus) that could affect periodontal status or cellular morphology

Treatment and study plan

Primary outcomes

  1. Nuclear morphological alterations in gingival epithelial cells

    Time frame: Baseline (at enrollment, single assessment)

    Quantitative assessment of nuclear morphological changes in exfoliated gingival epithelial cells, including micronuclei frequency, binucleated cells, nuclear-to-cytoplasmic (N/C) ratio alterations, and perinuclear halo formation, evaluated by light microscopy

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease Severity and Glycemic Control

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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