Annexin Levels of Periodontal Inflammatory Regulation

Annexin Levels in GCF Determine the Imbalance of Periodontal Inflammatory Regulation

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Periodontal Diseases
• Intervention / Treatment: Other: Saliva, serum and GCF sampling

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey
      • Istanbul Medipol University, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active Comparator; Saliva, serum and GCF collection of patients and samples molecules analysis	Other: Saliva, serum and GCF sampling; Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Gingival crevicular fluid (GCF) samples were taken from the vestibular, mesial, and distal surfaces of a single-rooted tooth with standard paper strips (Periopaper, Oraflow Inc., Plainview, NY, USA). Saliva, GCF and serum were then stored at -80 °C until analysis.
Experimental: Experimental; 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.	Other: Saliva, serum and GCF sampling; Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Gingival crevicular fluid (GCF) samples were taken from the vestibular, mesial, and distal surfaces of a single-rooted tooth with standard paper strips (Periopaper, Oraflow Inc., Plainview, NY, USA). Saliva, GCF and serum were then stored at -80 °C until analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket probing depth	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.	6 months
Clinical attachment level	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)	6 months
Bleeding on probing	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva, serum and GCF samples processing and analyses	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	1 month

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: periodontal disease; annexin
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Inflammation; Periodontal Diseases
• Other Study ID Numbers: 635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No