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NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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 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.

  2. Correlation of Bleeding on probing (BOP%)

    Time frame: 12-14 months

    Correlation of Bleeding on probing (BOP%) with level of hsCRP in oral rinse and serum samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Sanjay Tewari, MDS

CONTACT

[email protected]

94162259534 ext. 91

Neha Sahjlan, MDS

CONTACT

[email protected]

9821182607

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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