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CompletedNCT05281796Updated Nov 24, 2023

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

An observational study in Periodontal Diseases, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
66
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Periodontal Diseases

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Keywords

  • galectin-3
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 66 is below the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Dental patients will be recruited in a consecutive manner from the clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University. Medical history and dental history will be taken; thorough oral examination will be done. The aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. Nonrespondent patients or patients refusing to participate will be reported with the cause of their refusal. Conventional oral and periodontal examination will be held on a dental unit using the light of the unit, mirror and probe

Inclusion criteria

  1. 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.
  2. 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.
  3. For the periodontitis group that has not received periodontal treatment in the last 6 months
  4. 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.
  5. Presence of a minimum of 15 natural teeth.

Exclusion criteria

Exclusion Criteria:

  1. Individuals with any known systemic disease.
  2. Pregnant and lactating women.
  3. Individuals that received periodontal treatment within the last 6 months.
  4. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
  5. Former or current smokers.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • healthy patient

    Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

    Diagnostic Test: GCF obtaining · Diagnostic Test: saliva obtaining

  • gingivitis patient

    Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

    Diagnostic Test: GCF obtaining · Diagnostic Test: saliva obtaining

  • patients with Stage III periodontitis

    Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

    Diagnostic Test: GCF obtaining · Diagnostic Test: saliva obtaining

Interventions

  • Diagnostic testGCF obtaining

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

  • Diagnostic testsaliva obtaining

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

06

What researchers measure

Primary outcomes

  1. galectin-3 in GCF

    The total amount of Galectin-3 in GCF

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

  2. galectin-3 in saliva.

    The total amount of Galectin-3 in saliva

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

Secondary outcomes

  1. Pocket depth

    in mm

    Time frame: 24 hours before taking GCF and salivary samples

  2. Clinical attachment level

    in mm

    Time frame: 24 hours before taking GCF and salivary samples

  3. Bleeding on Probing

    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.

    Time frame: 24 hours before taking GCF and salivary samples

  4. Plaque Index

    Scores: 0: No plaque 1. 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. 2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

    Time frame: 24 hours before taking GCF and salivary samples

07

Study locations

1 site
  • Cairo university Faculty of dentistry
    Cairo, 11311, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05281796
Lead sponsor
Cairo University
Responsible party
Mohamed saad arafa ali (Principal Investigator mohamed saad, Cairo University) — Principal investigator
First posted
Mar 16, 2022
Start date
Jan 22, 2022
Primary completion
Jun 15, 2023
Completion
Aug 15, 2023
Last update
Nov 24, 2023

Study contacts

Mohamed Sa Ali, master's
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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