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Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07375719
Enrollment
95
Registered
2026-01-29
Start date
2024-03-01
Completion date
2026-01-14
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes (DM), Micronuclei Count, Periodontitis, Periodontitis (Stage 3)

Keywords

diabetes, periodontitis, cytology, nuclear aberrations

Brief 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.

Interventions

None listed

Sponsors

Çankırı Karatekin University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nuclear morphological alterations in gingival epithelial cellsBaseline (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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026