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Completed

NCT Number: NCT06554756

Annexin Levels 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.

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Key information

Conditions

Periodontal Diseases Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pocket probing depth

    Time frame: 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.

  2. Clinical attachment level

    Time frame: 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)

  3. Bleeding on probing

    Time frame: 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 outcomes

  1. Saliva, serum and GCF samples processing and analyses

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Annexin Levels in GCF Determine the Imbalance of Periodontal Inflammatory Regulation

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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