Gingivitis Clinical Trial
Official title:
Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker in Oral Rinse: A Cross Sectional Study
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | October 15, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Dental Sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Macrophage Inflammatory Protein-1a (MIP-1a) level | Evaluation of MIP-1a 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 | |
Primary | To correlate the MIP-1a levels with clinical periodontal parameters | To correlate the MIP-1a levels with clinical periodontal parameters (Gingival Index, Clinical Attachment Loss, Bleeding On Probing, Probing Pocket Depth) | 12-14 months |
Status | Clinical Trial | Phase | |
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