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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281796
• Other study ID #: 1512022
• Status: Completed
• Start date: January 22, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Diagnostic Test:
• GCF obtaining
GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)
• saliva obtaining
Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

Locations

Country	Name	City	State
Egypt	Cairo university Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	galectin-3 in GCF	The total amount of Galectin-3 in GCF	24 hours after taking the clinical measurements at the first visit
Primary	galectin-3 in saliva.	The total amount of Galectin-3 in saliva	24 hours after taking the clinical measurements at the first visit
Secondary	Pocket depth	in mm	24 hours before taking GCF and salivary samples
Secondary	Clinical attachment level	in mm	24 hours before taking GCF and salivary samples
Secondary	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
Secondary	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