Galectin Role in Periodontal Disease

Periodontitis Clinical Trial

Official title:

Outcome of Non-surgical Periodontal Treatment on Gal-1 & Gal-3 GCF Levels in Periodontitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06038812
• Other study ID #: REC-FDBSU/03082023-1/AM
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1 and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers and/or therapeutic targets for periodontitis, in addition to revealing their possible role in the periodontal disease.

45 systemically healthy participants were enrolled in this investigation, equally subdivided into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups (before and after non-surgical treatment for periodontitis group) using enzyme linked immune-sorbent assay (ELISA) kit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Non-smokers from both genders.

2. Not suffering from systemic diseases, pregnancy/lactation.

3. Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.

4. Patients with only gingivitis or periodontitis stage III.

5. Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.

Exclusion Criteria:

1. smokers.

2. having systemic diseases, pregnancy/lactation.

3. taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.

4. Patients having periodontitis any other stage than stage III.

5. Periodontitis patients who receive any professional periodontal treatment in the last 6 months.

Related Conditions & MeSH terms

• Gingivitis
• Periodontitis

Intervention

Diagnostic Test:
• GCF sample collection
collecting GCF from deepest sites by paper points

Procedure:
• non-surgical periodontal treatment
performing scaling and root planning using ultrasonic device and manual curettes

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Fayoum university	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of gal-1 and gal-3 in GCF samples	samples are to be sent to biochemistry lab to measure galectin levels	an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning