Viewing Study NCT06016023



Ignite Creation Date: 2024-05-06 @ 7:27 PM
Last Modification Date: 2024-10-26 @ 3:07 PM
Study NCT ID: NCT06016023
Status: RECRUITING
Last Update Posted: 2024-06-26
First Post: 2023-08-23

Brief Title: Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Organization: Postgraduate Institute of Dental Sciences Rohtak

Study Overview

Official Title: Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker in Oral Rinse A Cross Sectional Study
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 diseaseMIP-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: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None