NCT06016023|Completed
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Sponsor study identifier
observational
120
1 country
1
Study Start
September 1, 2023
Actual (reported)Primary Completion
October 1, 2024
Actual (reported)Study Completion
November 15, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2023
Actual (reported)August 29, 2023
Actual (reported)September 1, 2023
Actual (reported)October 1, 2024
Actual (reported)November 15, 2024
Actual (reported)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
Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis.
Group 2 comprises of 30 participants diagnosed with generalized gingivitis according to the WWP 2017 classification.
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 comprises of 30 participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis, according to WWP 2017 classification of periodontal disease.
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
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
RINDA SHARMA, BDS
PT. B. D. SHARMA UHSR HARYANA
120 participants (actual enrollment reported by the registry).
First Submitted
August 23, 2023
First Posted
August 29, 2023
Study Start
September 1, 2023
Actual (reported)Artificial Intelligence Evaluation of Periodontal Health Using Selfie Intraoral Photography
Contact the study team to confirm eligibility.
Primary Completion
October 1, 2024
Actual (reported)Study Completion
November 15, 2024
Actual (reported)Last Updated
January 15, 2025
Record last verified: 2025-01
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