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To measure the levels of marker (miR-155) related to immune cell macrophage phenotype shift in patients with healthy gingiva, and in those with periodontitis and type II diabetes mellitus

Comparative evaluation of miRNA 155 expression and its role in the regulation of macrophage polarization by correlating with TNF alpha and Arginase 1 levels, in stage III/IV periodontitis with and without type II diabetes mellitus An analytical case control study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/074146
Enrollment
64
Registered
2024-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Interventions

Intervention1: Group II: 16 Gingival tissue samples from systemically healthy subjects with Stage III/IV periodontitis. Group III :16 Gingival tissue samples from periodontally healthy, Type 2 Diab

Sponsors

Leya Mathews
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group II: Systemically healthy with localized stage III/IV periodontitis: Age group more than or equal to 18years Periodontal Probing depth more than or equal to 6mm Clinical attachment loss more than or equal to5mm Tooth loss due to periodontitis more than or equal to 5 teeth Radiographic evidence of bone loss Group III: Periodontally healthy with Type 2 diabetes mellitus. Age more than or equal to 18years Presence of at least 20 natural teeth excluding 3rd molars Patients with no gingival inflammation Probing Depth less than or equal to 3mm No clinical attachment loss Patients who are on oral hypoglycaemic drugs with HbA1c more than 7% Group IV: Type 2 diabetes mellitus with Grade B, Stage III/IV periodontitis group: Age more than or equal to 18years Periodontal Probing depth more than or equal to6mm Tooth loss due to periodontitis more than or equal to 5 teeth Radiographic evidence of bone loss. Patients who are on oral hypoglycaemic drugs with HbA1c 7%

Exclusion criteria

Exclusion criteria: Patients with any other systemic diseases/auto- immune diseases Patients under medication with immunosuppressants, antibiotics, anti-inflammatory drugs in the last six months History of periodontal therapy within the last 6 months. Pregnant or lactating mothers. Smokers (current and past) Subjects not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
To quantify and compare the gene expression of miR155, TN F alpha, Arginase-1 in Periodontal health and periodontitis with type II diabetes Timepoint: Baseline evaluation only—

Secondary

MeasureTime frame
1.To correlate the expression of miRNA-155, TNF-a & Arginase-1 with the clinical parameters in systemically healthy subjects with and without periodontitis and in Type II Diabetic subjects with and without periodontitis. 2. To evaluate the accuracy of miR155 in differentiating between periodontal health and periodontal disease in the presence and absence of type 2 diabetes mellitus. Timepoint: BASELINE—

Countries

India

Contacts

Public ContactDevapriya Appukuttan

SRM Dental College Ramapuram

devapriyamds@gmail.com9840197121

Outcome results

None listed

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