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Galectin Role in Periodontal Disease

Primary Purpose

Gingivitis, Periodontitis

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
GCF sample collection
non-surgical periodontal treatment
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gingivitis

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • faculty of dentistry, Fayoum university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group I

Group II

Group III

Arm Description

patients diagnosed with gingivitis

patients diagnosed with periodontitis

healthy control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
September 14, 2023
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT06038812
Brief Title
Galectin Role in Periodontal Disease
Official Title
Outcome of Non-surgical Periodontal Treatment on Gal-1 & Gal-3 GCF Levels in Periodontitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Other
Arm Description
patients diagnosed with gingivitis
Arm Title
Group II
Arm Type
Other
Arm Description
patients diagnosed with periodontitis
Arm Title
Group III
Arm Type
Other
Arm Description
healthy control
Intervention Type
Diagnostic Test
Intervention Name(s)
GCF sample collection
Intervention Description
collecting GCF from deepest sites by paper points
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
performing scaling and root planning using ultrasonic device and manual curettes
Primary Outcome Measure Information:
Title
assessment of gal-1 and gal-3 in GCF samples
Description
samples are to be sent to biochemistry lab to measure galectin levels
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
faculty of dentistry, Fayoum university
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Galectin Role in Periodontal Disease

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