Association Between Grade(B/C)of Stage III and IV Periodontitis and High Sensitivity C Reactive Protein Level in Serum and Oral Rinse Sample

NCT ID: NCT06997770

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-08-25

Brief Summary

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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

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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

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hsCRP

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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generalized periodontitis STAGE III/IV , Grade B

29 systemically healthy individuals With stage III /IV and grade B

No interventions assigned to this group

generalized periodontitis STAGE III/IV , Grade C

29 systemically healthy individuals With stage III /IV and grade C

No interventions assigned to this group

Periodontally healthy individuals

29 systemically and periodontally healthy individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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 .

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 undergoing radiotherapy
* Having received professional periodontal treatment within the previous 6 months
* Having received antibiotic medication 3 months prior to study
* Periapical pathology or other oral inflammatory conditions
* Cognitive disability (interfering with ability to give sample)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Aditi Sangwan, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS ,ROHTAK

Locations

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PGIDS

Rohtak, Haryana, India

Site Status

Countries

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India

Central Contacts

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Neha Sahjlan, MDS

Role: CONTACT

9821182607

Dr Sanjay Tewari, MDS

Role: CONTACT

94162259534 ext. 91

Facility Contacts

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Neha Sahjlan, MDS

Role: primary

9821182607

Dr Sanjay Tewari, MDS

Role: backup

9416259534

Other Identifiers

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Neha Sahjlan PeriodonticsPGIDS

Identifier Type: -

Identifier Source: org_study_id

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