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Clinical Trials/NCT06175624
NCT06175624
Completed
Not Applicable

Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Biomarker Levels

Biruni University1 site in 1 country75 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Biruni University
Enrollment
75
Locations
1
Primary Endpoint
Examination of CTRP-1 levels of periodontal disease and clinically healthy
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

Periodontal diseases are one of the most common inflammatory diseases. Periodontitis results from products and antigens of microorganisms, which stimulates the innate immune system and local inflammatory response; characterized by gingival inflammation, attachment loss, and alveolar bone destruction. Molecules that play a role in the pathogenesis of periodontal disease can be used as biomarkers in the early diagnosis of periodontitis, in determining the rate of periodontal destruction, and in evaluating the response to periodontal treatment.

CTRPs (C1q/TNF-related proteins), which are adiponectin paralogs, are involved in inflammation, lipid, and glucose metabolism, as well as physiological and pathological processes like vasodilation. CTRP-1 is a glycoprotein belonging to the CTRP family that can be detected in serum in the presence of certain antibodies. Serum CTRP-1 levels increase in type 2 diabetes, prediabetes, coronary artery diseases, congestive heart failure, and atherosclerosis. Lipopolysaccharides found in Gram-negative bacteria cell walls stimulate the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α and interleukin (IL)-1 β, as well as indirectly increasing the production of CTRP-1. CTRP-1 is a therapeutic target in many inflammatory diseases, including periodontal diseases. However, there are no clinical studies on the role of CTRP-1 in the pathogenesis of periodontal disease. Based on these findings, the goal of our research is to examine the effects of periodontal disease on CTRP-1, IL-10, and TNF-α levels in serum and gingival crevicular fluid samples taken before and after periodontal treatment from periodontally healthy individuals and individuals with gingivitis and periodontitis, and also determine whether CTRP-1 is a potential biomarker that can be used in the diagnosis of periodontal disease.

25 patients with periodontitis, 25 with gingivitis and 25 healthy periodontals (total of 75 individuals) will be included in our study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, and bleeding on probing), serum and gingival crevicular fluid samples will be taken from all individuals. Non-surgical periodontal treatment will be applied in quadrant wise within 2 weeks to individuals with gingivitis and periodontitis. 12 weeks after treatment; the clinical measurements and the collection of serum and gingival crevicular fluid will be repeated. Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
July 1, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biruni University
Responsible Party
Principal Investigator
Principal Investigator

Burcu KARADUMAN

Proffesor

Biruni University

Eligibility Criteria

Inclusion Criteria

  • Periodontal healthy group
  • Stage III Grade B Periodontitis Group
  • To meet the above-mentioned periodontal health and disease criteria

Exclusion Criteria

  • Periodontal tissues, periodontal disease course, periodontal application training and to have,
  • Chronic alcohol and cigarette use,
  • Oral contraceptive use, pregnancy, pregnant,
  • Use of antibiotics or anti-inflammatory drugs within the last 6 months,
  • Having undergone periodontal treatment in the last 6 months.

Outcomes

Primary Outcomes

Examination of CTRP-1 levels of periodontal disease and clinically healthy

Time Frame: up to 1 year

Examination of CTRP-1 levels, which are stated to be associated with periodontal disease, in gingival crevicular fluid and serum samples obtained from individuals with periodontitis.

Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.

Time Frame: up to 1 year

Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.

Comparison biomarkers of study groups.

Time Frame: up to 1 year

Comparison of gingival crevicular fluid and serum samples taken before treatment in individuals with periodontitis in terms of CTRP-1 levels.

Study Sites (1)

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