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

NCT ID: NCT06016023

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-11-15

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 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

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.

Conditions

Periodontitis Chronic Generalized Severe; Gingivitis; Inflammatory Response

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1: 30 periodontally healthy individuals.

Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis.

No interventions assigned to this group

Group 2: 30 individuals with generalized gingivitis

Group 2 comprises of 30 participants diagnosed with generalized gingivitis according to the WWP 2017 classification.

No interventions assigned to this group

Group 3: 30 participants with generalised mild/moderate (STAGE I/II) periodontitis

Group 3 comprises of 30 participants, diagnosed with generalized mild/moderate (STAGE I/II) periodontitis, according to the WWP 2017 classification of periodontal disease.

No interventions assigned to this group

Group 4: 30 participants with generalized severe/very severe (STAGE III/IV) periodontitis

Group 4 comprises of 30 participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis, according to WWP 2017 classification of periodontal disease.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RINDA SHARMA, BDS

Role: PRINCIPAL_INVESTIGATOR

PT. B. D. SHARMA UHSR HARYANA

Locations

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Countries

India

Other Identifiers

RINDAPERIO2023

Identifier Type: -

Identifier Source: org_study_id