Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease
NCT07375719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95
Last updated 2026-01-29
Summary
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.
Conditions
- Diabetes (DM)
- Periodontitis
- Periodontitis (Stage 3)
- Micronuclei Count
Sponsors & Collaborators
-
Çankırı Karatekin University
lead OTHER
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2026-01-14
- Completion
- 2026-01-14
Countries
- Turkey (Türkiye)
Study Locations
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