Diabetes (DM)NCT07375719
Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease
An observational study of Diabetes (DM) and Periodontitis, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes (DM), Periodontitis, Periodontitis (Stage 3)
- Type of treatment
- Injection or infusion
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 14 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 40 years
- Diagnosis of periodontitis according to the 2018 periodontal classification
- Absence of systemic diseases other than diabetes mellitus
Who cannot join
- 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
Show all 10Show fewer
- Known anemia
- Vitamin B12 deficiency
- Folate deficiency
- Presence of systemic diseases (other than diabetes mellitus) that could affect periodontal status or cellular morphology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- diabetes, periodontitis, cytology, nuclear aberrations
- Medical subject headings
- Diabetes Mellitus, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (at enrollment, single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Mar 2024
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Karasu, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375719
- Sponsor's protocol ID
- Decision No: 11; Date: 05/02/2
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to ethical restrictions and the observational nature of the study.
Publications
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.
PubMed 37593557Liu 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.
PubMed 26337468Agrawal 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.
PubMed 29516927Seifi 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.
PubMed 26029672Bastos-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
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.
PubMed 25428625Xiang 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.
PubMed 40660319GBD 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.
PubMed 30496104Papapanou 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.
PubMed 29926951Saravani 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.
PubMed 36686318GBD 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.
PubMed 37356446Omer 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 at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Abnormalities in Gingival Epithelial Cells in Relation to Periodontal Disease Severity and Glycemic Control
- ClinicalTrials.gov ID
- NCT07375719
- Acronym / sponsor ID
- Decision No: 11; Date: 05/02/2
- Keywords
- diabetes, periodontitis, cytology, nuclear aberrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 40 years
- Diagnosis of periodontitis according to the 2018 periodontal classification
- Absence of systemic diseases other than diabetes mellitus
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 37593557Serikova 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.
- Background: PubMed 26337468Liu 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.
- Background: PubMed 29516927Agrawal 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.
- Background: PubMed 26029672Seifi 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.
- BackgroundBastos-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: PubMed 25428625Brandao 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.
- Background: PubMed 40660319Xiang 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.
- Background: PubMed 30496104GBD 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.
- Background: PubMed 29926951Papapanou 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.
- Background: PubMed 36686318Saravani 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.
- Background: PubMed 37356446GBD 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.
- BackgroundOmer 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
- Individual participant dataSharing planned: No. IPD will not be shared due to ethical restrictions and the observational nature of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Periodontitis, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nuclear morphological alterations in gingival epithelial cells (time frame: Baseline (at enrollment, single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07375719, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.