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

NCT06016023 | Completed

• 1 other identifier: RINDAPERIO2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis Chronic Generalized Severe; Gingivitis; Inflammatory Response

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• RINDA SHARMA, BDS

  PT. B. D. SHARMA UHSR HARYANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 15, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

IN (1)