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Compare the levels of biomarkers involved in ferroptosis, a form of cell death in periodontitis patients with and without Type 2 Diabetes Mellitus

Comparative evaluation of Ferroptosis regulating markers - NCOA4, ACSL4 and NrF2 in Periodontitis with and without Type 2 Diabetes Mellitus: A Case-Control Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/077831
Enrollment
42
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Group II: 14 Gingival tissue samples from systemically healthy subjects with localized / generalized Stage III/IV periodontitis. Group III :14 Gingival tissue samples from subjects dia

Sponsors

Sriram Premkumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 2: Systemically healthy with localized / generalized stage III/IV periodontitis. 1.Age group = 18 years 2.FMPS >20% 3. FMBS > 10% 4.Periodontal probing depth = 6mm 5. Clinical attachment loss = 5mm 6.Radiographic evidence of bone loss extending to the middle or apical third of the root for stage III/IV periodontitis. 7.At least 20 natural teeth, excluding the third molars, (minimum 10 pairs of antagonistic teeth should be present) Group 3: Type 2 Diabetes Mellitus and localized / generalized stage III/IV periodontitis 1.Age = 18years 2.Periodontal Probing depth = 6mm 3.clinical attachment loss =5mm 4.FMPS >20% 5. FMBS >10% 6. Tooth loss due to periodontitis = 5 teeth 7.Radiographic evidence of bone loss 8.Patients diagnosed with type 2 diabetes mellitus and are on oral hypoglycemic drugs at least for 1 year duration with HbA1c value 8-10 %

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1.Patients under Immunosuppressants and or antibiotics and or anti- inflammatory medications and or any drugs that could influence the periodontium for the past 6 months. 2.Pregnant or lactating mothers 3.Current and past smokers 4.4.Previous history of periodontal or orthodontic therapy. 5.Patients with Uncontrolled diabetes mellitus (HbA1c >10%) 6. Type 2 diabetic subjects under insulin therapy and those reporting with a history of diabetic complications. 7.Subjects undergoing or those who had completed orthodontic treatment within 1 year. 8. Patients with a history of any other systemic disease other than type 2 DM and those diabetic individuals giving a history of diabetic complications, under insulin therapy, and HbA1c level >10% were excluded. 9.Subjects not willing to participate and not willing to give consent.

Design outcomes

Secondary

MeasureTime frame
1. To correlate the gene expression of Nrf2,NCOA4 & ACSL4 with the clinical parameters groupwise & in the total study samples. 2. To evaluate the ability of Nrf2,NCOA4 & ACSL4 levels to discriminate between periodontal health & disease using receiver operating curve analysis Timepoint: only base line values

Primary

MeasureTime frame
1.To quantify & compare gene expression of NRF2, NCOA4 & ACSL4 in periodontally & systemically healthy controls, with Stage III/IV periodontitis sites in patients, with & without T2DM. 2.To correlate between the levels of Nrf2,NCOA4 & ACSL4 markers in the various groups evaluated. Timepoint: only baseline evaluation

Countries

India

Contacts

Public ContactDr.Devapriya Appukuttan

SRM dental college

devapriyamds@gmail.com9840197121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026