Galectin Role in Periodontal Disease

Sponsor

Fayoum University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06038812

Collaborator

(none)

Enrollment

Location

Arms

2.8

Anticipated Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis Periodontitis	Diagnostic Test: GCF sample collection Procedure: non-surgical periodontal treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Group I patients diagnosed with gingivitis	Diagnostic Test: GCF sample collection collecting GCF from deepest sites by paper points
Other: Group II patients diagnosed with periodontitis	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
Other: Group III healthy control	Diagnostic Test: GCF sample collection collecting GCF from deepest sites by paper points

Arm

Intervention/Treatment

Other: Group I

patients diagnosed with gingivitis

Diagnostic Test: GCF sample collection

collecting GCF from deepest sites by paper points

Other: Group II

patients diagnosed with periodontitis

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

Other: Group III

healthy control

Diagnostic Test: GCF sample collection

collecting GCF from deepest sites by paper points

Outcome Measures

Primary Outcome Measures

assessment of gal-1 and gal-3 in GCF samples [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]
samples are to be sent to biochemistry lab to measure galectin levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Non-smokers from both genders.
Not suffering from systemic diseases, pregnancy/lactation.
Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs before inclusion in the study by 6 months.
Patients with only gingivitis or periodontitis stage III.
Periodontitis patients who did not receive any professional periodontal treatment in the last 6 months.

Exclusion Criteria:

smokers.
having systemic diseases, pregnancy/lactation.
taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs in the past 6 months.
Patients having periodontitis any other stage than stage III.
Periodontitis patients who receive any professional periodontal treatment in the last 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry, Fayoum university	Fayoum		Egypt

Sponsors and Collaborators

Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nayroz Tarrad, associate professor, Fayoum University

ClinicalTrials.gov Identifier:

NCT06038812

Other Study ID Numbers:

REC-FDBSU/03082023-1/AM

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Periodontitis

Study Results

No Results Posted as of Sep 15, 2023