Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease Severity and Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Nuclear morphological alterations in gingival epithelial cells
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 years
- •Diagnosis of periodontitis according to the 2018 periodontal classification
- •Absence of systemic diseases other than diabetes mellitus
排除标准
- •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
研究组 & 干预措施
Poor Glycemic Control - Stage I-II Periodontitis
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
Participants with diabetes mellitus and poor glycemic control (HbA1c ≥7%) diagnosed with Stage III-IV periodontitis.
Good Glycemic Control - Stage I-II Periodontitis
Participants with diabetes mellitus and good glycemic control (HbA1c <7%) diagnosed with Stage III-IV periodontitis.
Systemically Healthy - Stage I-II Periodontitis
Systemically healthy individuals without diabetes diagnosed with Stage I-II periodontitis.
Systemically Healthy - Stage III-IV Periodontitis
Systemically healthy individuals without diabetes diagnosed with Stage III-IV periodontitis.
Good Glycemic Control - Stage III-IV Periodontitis
Participants with diabetes mellitus and good glycemic control (HbA1c <7%) diagnosed with Stage III-IV periodontitis.
结局指标
主要结局
Nuclear morphological alterations in gingival epithelial cells
时间窗: 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
次要结局
未报告次要终点
研究者
Basak Karasu
Assist.Prof
Çankırı Karatekin University