Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Study Overview
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Brief Summary
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In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms . Periodontal disease is mixed infection resulting due to dysbiosis . When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers . Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.

Detailed Description
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In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms. Periodontal disease is mixed infection resulting due to dysbiosis. When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers. Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease. Periodontal diseases are classified according to the American academy of periodontology as stage 1, 2, 3&4 according to severity and extent of the disease progression. Stage 2 periodontitis was selected as it is considered as an intermediary, because CAL(clinical attachment loss was standardized at 3-4mm,this could reflect the progression of disease and its impact from a horizontal bone loss to a more oblique one, if in case the dysbiosis persists.

Official Title
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Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients With and Without Type 2 Diabetes

Conditions
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Periodontal Inflammation

Intervention / Treatment
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* Diagnostic Test: saliva analysis for Toll like receptor activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: *Untreated stage 2 periodontitis patients (n-60)-Age group 21-60 Non Smokers Diabetic patients controlled Not haven taken medications in the past 3 months Exclusion Criteria: smoker habits such as betel, tobacco chewing systemically unstable, Diabetes uncontrolled patients haven taken medications in the past 3 months Pregnant ladies Periodontal involvement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Selection of patients by grading the patients according to criteria patients without periodontal and systemic involvement(control), patients classified as stage 2 periodontitis without systemic involvement(test group1), patients classified as stage 2 Periodontitis with systemic disease(Type 2 diabetes)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control patients<br>Evaluation of Toll like receptor activity from whole saliva obtained from control patients | Diagnostic Test: saliva analysis for Toll like receptor activity<br>* Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity<br>|
| Active Comparator: Periodontal patients without diabetes<br>Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes | Diagnostic Test: saliva analysis for Toll like receptor activity<br>* Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity<br>|
| Active Comparator: Periodontal patients with diabetes<br>Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes | Diagnostic Test: saliva analysis for Toll like receptor activity<br>* Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toll like receptor 2 activity | Toll like receptor 2 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes | From baseline to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toll like receptor 4 activity | Toll like receptor 4 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes | From baseline to 5 months |