Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker (NCT06016023) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
India120 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level
Timeframe: 12-14 months
2
To correlate the MIP-1α levels with clinical periodontal parameters
Timeframe: 12-14 months
Trial details
NCT IDNCT06016023
SponsorPostgraduate Institute of Dental Sciences Rohtak