Periodontitis Chronic Generalized SevereNCT06016023
Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
An observational study of Periodontitis Chronic Generalized Severe and Gingivitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontitis Chronic Generalized Severe, Gingivitis, Inflammatory Response
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- • 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Chronic Generalized SevereStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RINDA SHARMA, BDS, Principal investigator, PT. B. D. SHARMA UHSR HARYANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016023
- Sponsor's protocol ID
- RINDAPERIO2023
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker in Oral Rinse: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06016023
- Acronym / sponsor ID
- RINDAPERIO2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level
Time frame: 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)
To correlate the MIP-1α levels with clinical periodontal parameters
Time frame: 12-14 months
To correlate the MIP-1α levels with clinical periodontal parameters (Gingival Index, Clinical Attachment Loss, Bleeding On Probing, Probing Pocket Depth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RINDA SHARMA, BDS principal investigator
PT. B. D. SHARMA UHSR HARYANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis Chronic Generalized Severe and Gingivitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level (time frame: 12-14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.