Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

NCT07375719 | Completed

• 1 other identifier: Decision No: 11; Date: 05/02/2
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

diabetes; periodontitis; cytology; nuclear aberrations

Outcome Measures

Primary Outcomes (1)

• Nuclear morphological alterations in gingival epithelial cells

  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

  Baseline (at enrollment, single assessment)

Study Arms (6)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with DM were stratified based on glycemic control, defined by HbA1c levels, and periodontal disease severity. Accordingly, patients with poor glycemic control (HbA1c ≥7%) were classified as having Stage I-II periodontitis (Group 1, n = 14) or Stage III-IV periodontitis (Group 2, n = 18), whereas patients with good glycemic control (HbA1c \<7%) were categorized as Stage I-II periodontitis (Group 3, n = 14) or Stage III-IV periodontitis (Group 4, n = 17). Systemically healthy individuals without diabetes served as controls and were further stratified according to periodontal disease severity, comprising Stage I-II periodontitis (Group 5, n = 16) and Stage III-IV periodontitis (Group 6, n = 16). This grouping strategy enabled assessment of both the independent and combined effects of periodontal disease severity and glycemic control on nuclear morphological alterations in gingival epithelial cells.

You may qualify if:

• Age ≥ 40 years
• Diagnosis of periodontitis according to the 2018 periodontal classification
• Absence of systemic diseases other than diabetes mellitus

You may not qualify if:

• 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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankırı Karatekin Üniversitesi

Çankırı, Turkey (Türkiye)

Location

Related Publications (12)

• Serikova OV, Shumilovich BR, Filippova ZA, et al (2023) Nuclear aberrations in the gingival epithelium of patients with chronic periodontitis. J Indian Soc Periodontol 27:374-380. https://doi.org/10.4103/jisp.jisp_18_22

  BACKGROUND

• Liu C-J, Chang W-J, Chen C-Y, et al (2015) Dynamic cellular and molecular modulations of diabetes mediated head and neck carcinogenesis. Oncotarget 6:29268-29284. https://doi.org/10.18632/oncotarget.4922

  BACKGROUND

• Agrawal R, Kumar N, Gupta K, Singh TB (2018) Correlation between fasting blood sugar and cytomorphometric values of diabetic patient's buccal mucosa exfoliative cytology. J Cancer Res Ther 14:398-402. https://doi.org/10.4103/jcrt.JCRT_1211_16

  BACKGROUND

• Seifi S, Feizi F, Moazzezi Z, et al (2014) Evaluation of oral mucosal epithelium in diabetic male patients by exfoliative cytology method. J Diabetes Metab Disord 13:77. https://doi.org/10.1186/2251-6581-13-77

  BACKGROUND

• Bastos-Aires D, Azevedo Á, de Lurdes Pereira M, et al (2013) Preliminary study of micronuclei levels in oral exfoliated cells from patients with periodontitis. J Dent Sci 8:200-204. https://doi.org/10.1016/j.jds.2012.12.007

  BACKGROUND

• Brandão P de TJ, Gomes-Filho IS, Cruz SS, et al (2015) Can periodontal infection induce genotoxic effects? Acta Odontol Scand 73:219-225. https://doi.org/10.3109/00016357.2014.982705

  BACKGROUND

• Xiang D, Sun Y, Jiao C, et al (2025) Diabetes and periodontitis: the role of a high-glucose microenvironment in periodontal tissue cells and corresponding therapeutic strategies. Stem Cell Res Ther 16:366. https://doi.org/10.1186/s13287-025-04441-z

  BACKGROUND

• James SL et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet 392:1789-1858

  BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, et al (2018) Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol 89:. https://doi.org/10.1002/JPER.17

  BACKGROUND

• Saravani S, Karimkoshteh A, Samaei Rahni M, Kadeh H (2021) Cytomorphometric Assessment of Buccal Mucosa Cells and Blood Sugar Status in Diabetic Patients in Zahedan (2019). Med J Islam Repub Iran. https://doi.org/10.47176/mjiri.

  BACKGROUND

• Ong KL et al. (2023) Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. The Lancet 402:203

  BACKGROUND

• Omer MAEM, Zeen AA-AM, Ahmed HAE, et al (2025) Assessment of Micronuclei Frequency in Buccal Mucosal Cells among Diabetic Patients in Shendi, Sudan: A Cross-Sectional Case-Control Study. Saudi Journal of Medicine 10:501-506. https://doi.org/10.36348/sjm.2025.v10i10.002

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 29, 2026
• Study Start: March 1, 2024
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)