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

February 6, 2023 updated by: Mohamed saad arafa ali, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy patient
Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained
Diagnostic test: GCF obtaining
GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
Diagnostic test: saliva obtaining
Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
gingivitis patient
Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained
Diagnostic test: GCF obtaining
GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
Diagnostic test: saliva obtaining
Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
patients with Stage III periodontitis
Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained
Diagnostic test: GCF obtaining
GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
Diagnostic test: saliva obtaining
Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after taking the clinical measurements at the first visit
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
24 hours after taking the clinical measurements at the first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pocket depth
Time Frame: 24 hours before taking GCF and salivary samples
in mm
24 hours before taking GCF and salivary samples
Clinical attachment level
Time Frame: 24 hours before taking GCF and salivary samples
in mm
24 hours before taking GCF and salivary samples
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.
24 hours before taking GCF and salivary samples
Plaque Index
Time Frame: 24 hours before taking GCF and salivary samples

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.
24 hours before taking GCF and salivary samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Sa Ali, master's, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 22, 2022

Primary Completion (ANTICIPATED)

August 15, 2023

Study Completion (ANTICIPATED)

December 15, 2023

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (ACTUAL)

March 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1512022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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