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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06016023
• Other study ID #: RINDAPERIO2023
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: September 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: ADITI SANGWAN, MDS
• Phone: 9996002408
• Email: aditidalal86[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 15, 2024
• Est. primary completion date: October 1, 2024
• 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)

Related Conditions & MeSH terms

• Gingivitis
• Inflammatory Response
• Periodontal Diseases
• Periodontitis
• Periodontitis Chronic Generalized Severe

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

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