Galectin Role in Periodontal Disease

January 11, 2024 updated by: Nayroz Tarrad, Fayoum University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Faculty of dentistry, Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of gal-1 and gal-3 in GCF samples
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-FDBSU/03082023-1/AM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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