Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease

January 26, 2026 updated by: Basak Karasu, Çankırı Karatekin University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nuclear morphological alterations in gingival epithelial cells
Time Frame: 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
Baseline (at enrollment, single assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Çankırı Karatekin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

January 14, 2026

Study Completion (Actual)

January 14, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Decision No: 11; Date: 05/02/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to ethical restrictions and the observational nature of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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