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Completed

NCT Number: NCT05281796

Evaluation of Galectin-3 Levels in GCF And Saliva of Patients With Different Periodontal Diseases

The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo university Faculty of dentistry

Cairo, 11311, Egypt

About this study

The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.

This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.

Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For healthy group: individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
  • For the gingivitis group: individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss.
  • For the periodontitis group that has not received periodontal treatment in the last 6 months
  • For the periodontitis group: individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss.
  • Presence of a minimum of 15 natural teeth.

Exclusion criteria

  • Individuals with any known systemic disease.
  • Pregnant and lactating women.
  • Individuals that received periodontal treatment within the last 6 months.
  • Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
  • Former or current smokers.

Treatment and study plan

GCF obtaining

Diagnostic Test

GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

saliva obtaining

Diagnostic Test

Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

Primary outcomes

  1. galectin-3 in GCF

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of Galectin-3 in GCF

  2. galectin-3 in saliva.

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of Galectin-3 in saliva

Secondary outcomes

  1. Pocket depth

    Time frame: 24 hours before taking GCF and salivary samples

    in mm

  2. Clinical attachment level

    Time frame: 24 hours before taking GCF and salivary samples

    in mm

  3. Bleeding on Probing

    Time frame: 24 hours before taking GCF and salivary samples

    By gently probing the orifice of the gingival crevice, the periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.

  4. Plaque Index

    Time frame: 24 hours before taking GCF and salivary samples

    Scores: 0: No plaque

    • A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen insitu only after application of a disclosing solution or by using the probe on the tooth surface.
    • Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
    • Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Gingival Crevicular Fluid And Salivary Levels of Galectin-3 in Patients With Gingivitis And Patients With Stage III Periodontitis: An Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
Nov 24, 2023

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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