Health Condition 1: K053- Chronic periodontitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: Systemically healthy individuals without Periodontitis (i) Age between 18-65 years (ii) Systemically healthy individuals with no history of systemic diseases (diabetes mellitus, hypertension, cardiovascular disease) (iii)Clinically healthy gingiva characterized by probing pocket depth (PPD less than 3mm, no clinical attachment loss, normal alveolar bone height on radiographs, no or minimal bleeding on probing. (iv) Non-smokers and non-tobacco users (no use in the past 6 months) (v) Not under medications affecting immune or inflammatory response. Group 2: Systemically healthy individuals with Generalized Stage II/III Periodontitis (i) Age between 18-65 years (ii) Systemically healthy individuals with no systemic diseases. (iii) Diagnosis of Generalized Stage II or Stage III periodontitis according to the 2017 world workshop on the classification of Periodontal and Peri-implant diseases and conditions. (iv) Non-smokers and non-tobacco users (no use in the past 6 months) (v) Not under medications influencing immune or inflammatory responses. Group 3: Subjects with Generalized Stage II/III Periodontitis and Stage I/II Rheumatoid arthritis (i) Age between 18-65 years. (ii) Diagnosis of Generalized Stage II or Stage III periodontitis as per the 2017 world workshop classification. (iii) Diagnosis of Stage I or Stage II Rheumatoid arthritis based on the 2010 ACR/EULAR classification criteria. (iv) Recently diagnosed Rheumatoid arthritis patients who have not initiated pharmacological treatment (DMARDs, corticosteroids, biologics or long term NSAIDs) (v) Non-smokers and non-tobacco users (no use in the past 6 months)
Exclusion criteria
Exclusion criteria: Group 1: Systemically Healthy Individuals without Periodontitis (i) Presence or history of periodontitis or gingivitis (ii) Any systemic disease or immunocompromised condition (iii) History of smoking or smokeless tobacco use within the last 6 months (iv) Current or recent use of anti-inflammatory drugs, immunosuppressants, corticosteroids, or antibiotics (within the past 3 months) (v) Pregnancy or lactation (vi) History of periodontal therapy within the last 6 months Group 2: Systemically Healthy Individuals with Generalized Stage II/III Periodontitis (i) Presence of any systemic inflammatory or autoimmune disease, including rheumatoid arthritis (ii) History of smoking or tobacco use within the last 6 months (iii) Use of antibiotics, anti-inflammatory drugs, corticosteroids, or immunomodulatory agents in the previous 3 months (iv) Periodontal treatment within the past 6 months (v) Pregnancy or lactation (vi) Any condition known to influence periodontal status or inflammatory biomarkers Group 3: Subjects with Generalized Stage II/III Periodontitis and Stage I/II Rheumatoid Arthritis (i)Advanced rheumatoid arthritis (Stage III or IV) (ii) History of treatment with DMARDs, biologics, corticosteroids, or long-term NSAIDs (iii) Presence of other systemic, inflammatory or autoimmune diseases (iv) History of smoking or tobacco use within the past 6 months (v) Periodontal therapy within the last 6 months (vi) Pregnancy or lactation (vii) Any acute infection or condition that could influence inflammatory or oxidative stress markers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Salivary SIRT1 concentration will be measured using sandwich ELISA. 2)Salivary NRF2 protein concentration will be measured using sandwich ELISA. 3)Relative gene expression levels of SIRT1 and NRF2 in peripheral blood samples will be measured using RT-qPCR.Timepoint: Baseline (Single time-point assessment at the time of recruitment prior to any treatment intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Correlation between salivary SIRT1 protein levels and clinical periodontal parameters (probing pocket depth, clinical attachment loss, bleeding on probing). 2)Correlation between salivary NRF2 protein levels and clinical periodontal parameters (probing pocket depth, clinical attachment loss, bleeding on probing). 3)Association between SIRT1 and NRF2 gene expression levels and presence of rheumatoid arthritis. 4)Comparison of biomarker levels (SIRT1 and NRF2 protein and gene expression) among the three study groups.Timepoint: Baseline (Single time point assessment at recruitment during the study visit) | — |
Countries
India
Contacts
SRM Dental College, Ramapuram