EVALUATION OF MACROPHAGE INFLAMMATORY PROTEIN-1α AS A PERIODONTAL DISEASE BIOMARKER

Sponsor
Postgraduate Institute of Dental Sciences Rohtak (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06016023
Collaborator
(none)
120
1
13.5
8.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    EVALUATION OF MACROPHAGE INFLAMMATORY PROTEIN-1α AS A PERIODONTAL DISEASE BIOMARKER IN ORAL RINSE: A CROSS SECTIONAL STUDY
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Oct 15, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level [12-14 months]

      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)

    2. To correlate the MIP-1α levels with clinical periodontal parameters [12-14 months]

      To correlate the MIP-1α levels with clinical periodontal parameters (GI, CAL, BOP, PPD)

    Secondary Outcome Measures

    1. To correlate difference in MIP-1α levels of patients with their demographic and anthropometric data [12-14 months]

      To correlate difference in MIP-1α levels of patients with their demographic and anthropometric (BMI) data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Post Graduate Institute of Dental Sciences Rohtak Haryana India 124001

    Sponsors and Collaborators

    • Postgraduate Institute of Dental Sciences Rohtak

    Investigators

    • Principal Investigator: RINDA SHARMA, BDS, PT. B. D. SHARMA UHSR HARYANA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Postgraduate Institute of Dental Sciences Rohtak
    ClinicalTrials.gov Identifier:
    NCT06016023
    Other Study ID Numbers:
    • RINDAPERIO2023
    First Posted:
    Aug 29, 2023
    Last Update Posted:
    Aug 29, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 29, 2023