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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175624
• Other study ID #: 2015-KAEK-79-23-07
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: December 2023
• Source: Biruni University
• Contact: Asena Kadayif
• Phone: 05382571317
• Email: asenakadayif[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Healthy
• Periodontitis

Intervention

Other:
• Clinically Helathy
Our study will include 25 people with clinically healthy patients. Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study.
• Gingivitis
Our study will include 25 people with gingivitis patients. Gingival crevicular fluid and serum will be collected during the clinical measurements Biomarkers in serum and gingival crevicular fluid samples will be examined by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and sample will be taken from all individuals at the beginning of the study.
• Periodontitis
Our study will include 25 people with periodontitis patients. Non-surgical periodontal treatment will be applied to individuals with periodontitis, serum and gingival crevicular fluid samples will be collected before the treatment, clinical measurements and gingival crevicular fluid and serum collection will be repeated 12 weeks after the treatment. CTRP-1 analysis will be performed by ELISA. CTRP-1 levels will be examined to evaluate the effects of periodontal treatment in periodontal health, gingivitis and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.

Locations

Country	Name	City	State
Turkey	Biruni Üniversity	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of CTRP-1 levels of periodontal disease and clinically healthy	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.	up to 1 year
Primary	Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.	Evaluation of the effect of non-surgical periodontal treatment on changes in CTRP-1 level.	up to 1 year
Primary	Comparison biomarkers of study groups.	Comparison of gingival crevicular fluid and serum samples taken before treatment in individuals with periodontitis in terms of CTRP-1 levels.	up to 1 year