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Not yet recruiting 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

Observational hsCRP

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: hsCRP. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals [Time frame: 12-14 months]
Secondary outcome measures (2)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

India · 1 center
  • PGIDS — Rohtak

Identifiers

NCT: NCT06997770 · Neha Sahjlan PeriodonticsPGIDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗