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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Çankırı Karatekin Üniversitesi | Çankırı | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37593557 | Background | Serikova OV, Shumilovich BR, Filippova ZA, Kalaev VN, Kalaeva EA, Larina AV. Nuclear aberrations in the gingival epithelium of patients with chronic periodontitis. J Indian Soc Periodontol. 2023 Jul-Aug;27(4):374-380. doi: 10.4103/jisp.jisp_18_22. Epub 2023 Jul 1. | |
| 26337468 | Background | Liu CJ, Chang WJ, Chen CY, Sun FJ, Cheng HW, Chen TY, Lin SC, Li WC. Dynamic cellular and molecular modulations of diabetes mediated head and neck carcinogenesis. Oncotarget. 2015 Oct 6;6(30):29268-84. doi: 10.18632/oncotarget.4922. |
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IPD will not be shared due to ethical restrictions and the observational nature of the study.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 29516927 | Background | Agrawal R, Kumar N, Gupta K, Singh TB. Correlation between fasting blood sugar and cytomorphometric values of diabetic patient's buccal mucosa exfoliative cytology. J Cancer Res Ther. 2018 Jan-Mar;14(2):398-402. doi: 10.4103/jcrt.JCRT_1211_16. |
| 26029672 | Background | Seifi S, Feizi F, Moazzezi Z, Mehdizadeh M, Zamani B. Evaluation of oral mucosal epithelium in diabetic male patients by exfoliative cytology method. J Diabetes Metab Disord. 2014 Sep 10;13:77. doi: 10.1186/2251-6581-13-77. eCollection 2014. |
| 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 |
| 25428625 | Background | Brandao Pde T, Gomes-Filho IS, Cruz SS, Passos-Soares Jde S, Trindade SC, Souza Lda C, Meireles JR, Cerqueira Ede M. Can periodontal infection induce genotoxic effects? Acta Odontol Scand. 2015 Apr;73(3):219-25. doi: 10.3109/00016357.2014.982705. Epub 2014 Nov 27. |
| 40660319 | Background | Xiang DD, Sun YX, Jiao C, Guo YQ, Fei YX, Ren BQ, He XT, Li X. Diabetes and periodontitis: the role of a high-glucose microenvironment in periodontal tissue cells and corresponding therapeutic strategies. Stem Cell Res Ther. 2025 Jul 15;16(1):366. doi: 10.1186/s13287-025-04441-z. |
| 30496104 | Background | GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. 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. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. |
| 29926951 | Background | Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721. |
| 36686318 | Background | Saravani S, Karimkoshteh A, Samaei Rahni M, Kadeh H. Cytomorphometric Assessment of Buccal Mucosa Cells and Blood Sugar Status in Diabetic Patients in Zahedan (2019). Med J Islam Repub Iran. 2021 Dec 18;35:168. doi: 10.47176/mjiri.35.168. eCollection 2021. |
| 37356446 | Background | GBD 2021 Diabetes Collaborators. 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. Lancet. 2023 Jul 15;402(10397):203-234. doi: 10.1016/S0140-6736(23)01301-6. Epub 2023 Jun 22. |
| 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 |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |