Annexin Levels of Periodontal Inflammatory Regulation

NCT06554756 | Completed

• 1 other identifier: 635
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Inflammation

Keywords

periodontal disease; annexin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Saliva, serum and GCF samples processing and analyses

  1 month

Study Arms (2)

Active Comparator

OTHER

Saliva, serum and GCF collection of patients and samples molecules analysis

Other: Saliva, serum and GCF sampling

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

Interventions

Saliva, serum and GCF sampling OTHER

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.

Active Comparator; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• systemically healthy
• clinical diagnosis of periodontitis
• clinical diagnosis of periodontal health

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Location

Related Publications (1)

• Yilmaz M, Bal I, Hanli S, Turkmen E, Balci N, Toygar HU. Annexin levels in GCF determine the imbalance of periodontal inflammatory regulation. Sci Rep. 2024 Nov 21;14(1):28833. doi: 10.1038/s41598-024-80418-x.

  PMID: 39572681 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Inflammation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof Dr

Model Details: Saliva, serum and gingival crevicular fluid of periodontitis patients collected for analyzing anxa1, anxa2 and IL-1beta

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: May 15, 2023
• Primary Completion: December 25, 2023
• Study Completion: March 12, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)