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

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: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: GCF obtaining; Diagnostic test: saliva obtaining

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

• Study Contact: Name: mohamed sa ali, master; Phone Number: +201144881809; Email: mohamed.saad@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Recruiting
    • Cairo University Faculty of Dentistry
    • Contact: mohamed sa ali, master; Phone Number: +201144881809; Email: mohamed.saad@dentistry.cu.edu.eg

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

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	The total amount of Galectin-3 in GCF	24 hours after taking the clinical measurements at the first visit
galectin-3 in saliva.	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	in mm	24 hours before taking GCF and salivary samples
Clinical attachment level	in mm	24 hours before taking GCF and salivary samples
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.	24 hours before taking GCF and salivary samples
Plaque Index	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.	24 hours before taking GCF and salivary samples

Collaborators and Investigators

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

Study record dates

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: galectin-3
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 1512022