Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

Çankırı Karatekin University

Status: Completed

Conditions: Micronuclei Count; Periodontitis; Diabetes (DM); Periodontitis (Stage 3)

Study type: Observational

Funder types: Other

Identifiers

NCT07375719

Decision No: 11 Date: 05/02/2;

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

95 participants in 6 patient groups

Poor Glycemic Control - Stage I-II Periodontitis

Description:

Participants with diabetes mellitus and poor glycemic control (HbA1c ≥7%) diagnosed with Stage I-II periodontitis according to the 2018 periodontal classification.

Poor Glycemic Control - Stage III-IV Periodontitis

Description:

Participants with diabetes mellitus and poor glycemic control (HbA1c ≥7%) diagnosed with Stage III-IV periodontitis.

Good Glycemic Control - Stage I-II Periodontitis

Description:

Participants with diabetes mellitus and good glycemic control (HbA1c \<7%) diagnosed with Stage III-IV periodontitis.

Systemically Healthy - Stage I-II Periodontitis

Description:

Systemically healthy individuals without diabetes diagnosed with Stage I-II periodontitis.

Systemically Healthy - Stage III-IV Periodontitis

Description:

Systemically healthy individuals without diabetes diagnosed with Stage III-IV periodontitis.

Good Glycemic Control - Stage III-IV Periodontitis

Description:

Participants with diabetes mellitus and good glycemic control (HbA1c \<7%) diagnosed with Stage III-IV periodontitis.