hsCRPNCT06997770
Association Between Grade(B/C)of Stage III and IV Periodontitis and High Sensitivity C Reactive Protein Level in Serum and Oral Rinse Sample
An observational study of hsCRP, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
According to 2017 World Workshop of Periodontology , the level of high sensitivity C reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- hsCRP
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jun 2025to 25 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Group 1: comprising of periodontally healthy individuals. 2. Group 2: comprising of individuals, diagnosed with stage III and stage IV grade B periodontitis (according to WWP 2017 classification periodontal disease ) 3. Group 3: comprising of participants, diagnosed with stage III and IV grade C periodontitis,
Who may be able to join
- Patients in the age group of (18-50 years)
- Presence of ≥ 20 natural teeth
- Ability and willingness to give written informed consent
- Patients belonging to 3 groups -periodontally healthy, stage III and stage IV grade B periodontitis, and stage III and stage IV grade C 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 undergoing radiotherapy
- Having received professional periodontal treatment within the previous 6 months
Show all 9Show fewer
- Having received antibiotic medication 3 months prior to study
- Periapical pathology or other oral inflammatory conditions
- Cognitive disability (interfering with ability to give sample)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
PGIDS
Rohtak, Haryana, 124001
Neha Sahjlan, MDS, 9821182607, nehasahjlan267@gmail.com
Dr Sanjay Tewari, MDS, 9416259534, principal.pgids@uhsr.ac.in
About this study
Official title: Association Between Grade (B/C)of Stage III and Stage IV Periodontitis and High Sensitivity C Reactive Protein Levels in Serum and Oral Rinse Sample :A Cross Sectional Study
According to 2017 World Workshop of Periodontology , the level of high sensitivity C reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Hence, measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in gaining insight on the systemic burden of periodontal disease.
Read the detailed description
According to 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions , the level of high sensitivity c reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Moreover, no information is currently available regarding the feasibility of detecting high sensitivity in oral rinse samples, which are relatively easy to collect and store, as compared to more commonly investigated oral fluids like saliva and gingival crevicular fluid Previous literature reports that saliva and gingival crevicular fluid levels of high sensitivity C reactive protein correlate with serum high sensitivity C reactive protein levels, therefore, there is a possibility that high sensitivity C reactive protein in oral rinse samples might also be correlated with serum high sensitivity C reactive protein levels. Measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in providing easily accessible information about the systemic burden of periodontal inflammation as well as regarding detection of subclinical systemic inflammation.
- Conditions
- hsCRP
- Keywords
- periodontits
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 |
|---|---|---|
| generalized periodontitis STAGE III/IV , Grade B | 29 systemically healthy individuals With stage III /IV and grade B | |
| generalized periodontitis STAGE III/IV , Grade C | 29 systemically healthy individuals With stage III /IV and grade C | |
| Periodontally healthy individuals | 29 systemically and periodontally healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals
Evaluation of hsCRP level in oral rinse samples and serum in 3 groups of systemically healthy individuals (periodontally healthy, stage III and stage IV grade B generalized periodontitis, stage III and stage IV grade C generalized periodontitis)
Measured: 12-14 months
Secondary outcomes (2)
Correlation of Probing pocket depth (PPD)and Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples.
Correlation of Probing pocket depth (PPD) with level of hsCRP in oral rinse and serum samples.
Correlation of Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples.
Measured: 12-14 months
Correlation of Bleeding on probing (BOP%)
Correlation of Bleeding on probing (BOP%) with level of hsCRP in oral rinse and serum samples.
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 posted30 May 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for hsCRPStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Aditi Sangwan, MDS, Principal investigator, PGIDS ,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997770
- Sponsor's protocol ID
- Neha Sahjlan PeriodonticsPGIDS
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Grade (B/C)of Stage III and Stage IV Periodontitis and High Sensitivity C Reactive Protein Levels in Serum and Oral Rinse Sample :A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06997770
- Acronym / sponsor ID
- Neha Sahjlan PeriodonticsPGIDS
- Conditions
- hsCRP
- Keywords
- periodontits
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 30 May 2025 (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.
According to 2017 World Workshop of Periodontology , the level of high sensitivity C reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Hence, measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in gaining insight on the systemic burden of periodontal disease.
Detailed description
According to 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions , the level of high sensitivity c reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Moreover, no information is currently available regarding the feasibility of detecting high sensitivity in oral rinse samples, which are relatively easy to collect and store, as compared to more commonly investigated oral fluids like saliva and gingival crevicular fluid Previous literature reports that saliva and gingival crevicular fluid levels of high sensitivity C reactive protein correlate with serum high sensitivity C reactive protein levels, therefore, there is a possibility that high sensitivity C reactive protein in oral rinse samples might also be correlated with serum high sensitivity C reactive protein levels. Measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in providing easily accessible information about the systemic burden of periodontal inflammation as well as regarding detection of subclinical systemic inflammation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| generalized periodontitis STAGE III/IV , Grade B | – | –29 systemically healthy individuals With stage III /IV and grade B |
| generalized periodontitis STAGE III/IV , Grade C | – | –29 systemically healthy individuals With stage III /IV and grade C |
| Periodontally healthy individuals | – | –29 systemically and periodontally healthy individuals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Group 1: comprising of periodontally healthy individuals. 2. Group 2: comprising of individuals, diagnosed with stage III and stage IV grade B periodontitis (according to WWP 2017 classification periodontal disease ) 3. Group 3: comprising of participants, diagnosed with stage III and IV grade C periodontitis,
Key inclusion criteria (4 listed)
- Patients in the age group of (18-50 years)
- Presence of ≥ 20 natural teeth
- Ability and willingness to give written informed consent
- Patients belonging to 3 groups -periodontally healthy, stage III and stage IV grade B periodontitis, and stage III and stage IV grade C periodontitis .
Key exclusion criteria (9 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 hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals
Time frame: 12-14 months
Evaluation of hsCRP level in oral rinse samples and serum in 3 groups of systemically healthy individuals (periodontally healthy, stage III and stage IV grade B generalized periodontitis, stage III and stage IV grade C generalized periodontitis)
2 secondary outcomes
Correlation of Probing pocket depth (PPD)and Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples.
Time frame: 12-14 months
Correlation of Bleeding on probing (BOP%)
Time frame: 12-14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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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.
Dr Aditi Sangwan, MDS principal investigator
PGIDS ,ROHTAK
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 hsCRP, 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 30 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Sahjlan, MDS (9821182607, nehasahjlan267@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals (time frame: 12-14 months). 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 30 May 2025.