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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Inflammatory Response; Periodontitis Chronic Generalized Severe

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population will include consecutive subjects referred to the Department of Periodontics, PGIDS, Rohtak. The patients will be screened according to the inclusion and exclusion criteria for eligibility to participate in the study.

The participants will comprise of the following groups :-

1. Group 1: comprising of periodontally healthy individuals.
2. Group 2: comprising of individuals, diagnosed with generalized gingivitis
3. Group 3: comprising of participants, diagnosed with generalized mild/moderate (STAGE I/II) periodontitis
4. Group 4: comprising of participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group 1: 30 periodontally healthy individuals.; Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis.
Group 2: 30 individuals with generalized gingivitis; 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; 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; 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?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To correlate difference in MIP-1α levels of patients with their demographic and anthropometric data	To correlate difference in MIP-1α levels of patients with their demographic and anthropometric (BMI) data	12-14 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: RINDA SHARMA, BDS, PT. B. D. SHARMA UHSR HARYANA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontitis; Periodontal Diseases; Gingivitis
• Other Study ID Numbers: RINDAPERIO2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No