Annexin Levels of Periodontal Inflammatory Regulation

Not Applicable

Completed

• Conditions: Inflammation; Periodontal Diseases
• Interventions: Other: Saliva, serum and GCF sampling

• Registration Number: NCT06554756
• Lead Sponsor: Medipol University

Brief Summary

ANXA1, a member of the annexin family, plays a role in the resolution of inflammation and the regulation of anti-inflammatory responses, while ANXA2 is involved in the initiation of the inflammatory responses. The aim of this study was to determine the effects of annexin family (ANXA1 and ANXA2) in periodontal disease.

Detailed Description

Healthy participants (n:25) and stage III, grade B periodontitis (n:25) patients enrolled for this study. Clinical periodontal parameters and PISA levels were noted. Serum, saliva, and GCF samples were collected to measure the ANXA1, ANXA2 and IL-1β levels.

Study Timeline

• Study Start: 2023-05-15
• Primary Completion: 2023-12-25
• Study Completion: 2024-03-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

systemically healthy

• clinical diagnosis of periodontitis
• clinical diagnosis of periodontal health

Exclusion Criteria

• • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)

  • nonsurgical periodontal treatment (previous 6 months)
  • surgical periodontal treatment (previous 12 months)
  • presence of<10 teeth
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
  • diabetes
  • diagnosis of rheumatoid arthritis
  • pregnancy
  • lactating
  • smoking
  • excessive alcohol consumption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Comparator	Saliva, serum and GCF sampling	Saliva, serum and GCF collection of patients and samples molecules analysis
Experimental	Saliva, serum and GCF sampling	Salivary, serum and GCF ANXA1, ANXA2 and IL-1beta observation Saliva, serum and GCF samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for ANXA1, ANXA2 and IL-1beta using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.

Primary Outcome Measures

Name	Time	Method
Pocket probing depth	6 months	Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Clinical attachment level	6 months	Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.; To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.; In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Bleeding on probing	6 months	referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.

Secondary Outcome Measures

Name	Time	Method
Saliva, serum and GCF samples processing and analyses	1 month	Saliva, GCF and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for ANXA1, ANXA2 and IL-1beta using commercial ELISA kits

Trial Locations

Locations (1)

Istanbul Medipol University, School of Dentistry; 🇹🇷 Istanbul, Fatih, Turkey