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NCT07375719

Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

Completed Last updated 29 January 2026
What this trial tests

trial in Diabetes (DM) in 95 participants. Completed in 14 January 2026.

Timeline
1 March 2024
Primary endpoint
14 January 2026
14 January 2026

Quick facts

Lead sponsorÇankırı Karatekin University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment95
Start date1 March 2024
Primary completion14 January 2026
Estimated completion14 January 2026
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

Çankırı Karatekin University

Who can join

40 and older, any sex, with Diabetes (DM) or Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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