Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker

Study Overview
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Brief Summary
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Periodontal disease is a chronic progressive state of inflammation pertaining to supporting tissues of the dentition that culminates in loss of the affected teeth. Currently, diagnosis and monitoring of periodontal disease progression is accomplished by performing a full-mouth clinical and radiological examination which is time-consuming and also requires elaborate infrastructure and equipment, which are not always available. Limitations of the conventional diagnostic techniques necessitate the development of point-of-care testing (POCT) which could serve as a rapid, feasible and affordable screening tool for periodontal disease.MIP-1α is a cysteine-cysteine (C-C) chemokine that is secreted by a variety of cells like macrophages, fibroblasts, epithelial cells and endothelial cells. They principally serve to recruit leukocytes like monocytes, T lymphocytes, natural killer cells, dendritic cells and granulocytes to the site of inflammation. Hence, the current study has a two fold aim; first, to determine the feasibility of MIP-1α as a periodontal disease biomarker; and second, to correlate the value of MIP-1α obtained from oral rinse sample with the periodontal disease severity.

Detailed Description
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Periodontal disease is a chronic progressive state of inflammation pertaining to supporting tissues of the dentition that culminates in loss of the affected teeth. The term broadly covers both gingivitis (inflammation of the gingival connective tissue) and periodontitis (loss of supporting alveolar bone as a consequence of sustained inflammatory load on the supportive periodontal tissues). Currently, diagnosis and monitoring of periodontal disease progression is accomplished by performing a full-mouth clinical and radiological examination which is time-consuming and also requires elaborate infrastructure and equipment, which are not always available. These limitations of the conventional diagnostic techniques necessitate the development of point-of-care testing (POCT) which could serve as a rapid, feasible and affordable screening tool for periodontal disease. Of late, chemokines have become the subject of interest for potential application as biomarkers for periodontal screening. MIP-1α is a cysteine-cysteine (C-C) chemokine that is secreted by a variety of cells like macrophages, fibroblasts, epithelial cells and endothelial cells. They principally serve to recruit leukocytes like monocytes, T lymphocytes, natural killer cells, dendritic cells and granulocytes to the site of inflammation. The primary challenge faced by researchers in analysis of host derived oral biomarkers in any sample fluid is the establishment of normal level of various biomarkers. This problem arises as the biomarkers that are found at exaggerated levels in periodontal inflammation are also detected in oral fluids in healthy periodontium but at a much lower value. Hence, the current study has a two fold aim; first, to determine the feasibility of MIP-1α as a periodontal disease biomarker; and second, to correlate the value of MIP-1α obtained from oral rinse sample with the periodontal disease severity.

Official Title
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Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker in Oral Rinse: A Cross Sectional Study

Conditions
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Periodontitis Chronic Generalized Severe, Gingivitis, Inflammatory Response

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of ≥ 20 natural teeth Ability and willingness to give written informed consent Patients belonging to 4 groups -periodontally healthy, generalized gingivitis, generalized stage I/II periodontitis, generalized stage III/IV periodontitis Exclusion Criteria: • Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years Smokers and alcoholics Pregnant females Presence of xerostomia Patients with oral lesions or other contact sensitivity Patients suffering from autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis Patients with acute or chronic use of medications that cause oral dryness Patients undergoing radiotherapy Patients with Grade C periodontitis Having received professional periodontal treatment within the previous 12 months Having received antibiotic medication 3 months prior to study Periapical pathology or other oral inflammatory conditions Cognitive disability (interfering with ability to give samples)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: 30 periodontally healthy individuals.<br>Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis. | |
| Group 2: 30 individuals with generalized gingivitis<br>Group 2 comprises of 30 participants diagnosed with generalized gingivitis according to the WWP 2017 classification. | |
| Group 3: 30 participants with generalised mild/moderate (STAGE I/II) periodontitis<br>Group 3 comprises of 30 participants, diagnosed with generalized mild/moderate (STAGE I/II) periodontitis, according to the WWP 2017 classification of periodontal disease. | |
| Group 4: 30 participants with generalized severe/very severe (STAGE III/IV) periodontitis<br>Group 4 comprises of 30 participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis, according to WWP 2017 classification of periodontal disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level | Evaluation of MIP-1α level in sample across 4 groups of systemically healthy individuals (periodontally healthy, generalized gingivitis, generalized stage I/II periodontitis, generalized stage III/IV periodontitis) | 12-14 months | 
| To correlate the MIP-1α levels with clinical periodontal parameters | To correlate the MIP-1α levels with clinical periodontal parameters (Gingival Index, Clinical Attachment Loss, Bleeding On Probing, Probing Pocket Depth) | 12-14 months |