Clinical trial NCT06997770: Association Between Grade(B/C)of Stage III and IV Periodontitis and High Sensitivity C Reactive Protein Level in Serum and Oral Rinse Sample
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: hsCRP
Keywords: periodontits
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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,

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals
timeFrame: 12-14 months
Secondary outcomes:
measure: Correlation of Probing pocket depth (PPD)and Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples.
timeFrame: 12-14 months
measure: Correlation of Bleeding on probing (BOP%)
timeFrame: 12-14 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS ,ROHTAK
name: Dr Aditi Sangwan, MDS
role: PRINCIPAL_INVESTIGATOR
References: