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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: hsCRP

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 Type: Observational
• Enrollment (Estimated): 87

Contacts and Locations

• Study Contact: Name: Neha Sahjlan, MDS; Phone Number: 9821182607; Email: nehasahjlan267@gmail.com
• Study Contact Backup: Name: Dr Sanjay Tewari, MDS; Phone Number: 91 94162259534; Email: principal.pgids@uhsr.ac.in

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS
      • Contact: Neha Sahjlan, MDS; Phone Number: 9821182607; Email: nehasahjlan267@gmail.com
      • Contact: Dr Sanjay Tewari, MDS; Phone Number: 9416259534; Email: principal.pgids@uhsr.ac.in
      • Principal Investigator: Dr Aditi Sangwan, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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,

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12-14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12-14 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr Aditi Sangwan, MDS, PGIDS ,ROHTAK

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): August 25, 2026

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: periodontits
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: Neha Sahjlan PeriodonticsPGIDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No