IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis

May 19, 2023 updated by: Sandy Hassan, Fayoum University
The sudy was aiming to assess and compare GCF levels of IL-39 & IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodology:

Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM age range, 35-50 years.

Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis & systemically healthy, age range: 35-50 years.

Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as control subjects age range: 30-45 years.

Periodontitis participants will be collected from the outpatient clinic of oral medicine and periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS, Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)

Diabetic patients will be enrolled in this study according to the criteria of American Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 38: S8-S16, 2015.)

The control group will be selected from healthy subjects who attended the restorative dental clinic and has apparently clinically healthy gingiva.

Micropipettes will be used for collection of GCF samples for control group and periodontitis patients before & after periodontal treatment.

A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis groups

The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the guidelines by the manufacturer.

Study Type

Interventional

Enrollment (Actual)

57

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
      • Cairo, Egypt
        • Sandy hassan shaaban
    • Virginia
      • Cairo, Virginia, Egypt, 22039
        • Sandy hassan

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 Stage III Grade C Generalized periodontitis with diabetes Stage III grade B Generalized periodontitis in systemic healthy subjects

Exclusion Criteria:

  1. Patients treated with any type of medications and/ or antibiotics during the past 3 months,
  2. Pregnancy
  3. Lactation
  4. Receiving professional periodontal treatment during the past 6 months
  5. Current or former smokers

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Systemically healthy periodontitis
Non Surgical Periodontal therapy ( Scaling & Root planning)
Procedure: Scaling & root planning
Non Surgical periodontal therapy
Active Comparator: Diabetic & Periodontitis
Non surgical periodontal therapy ( scaling & root planning)
Procedure: Scaling & root planning
Non Surgical periodontal therapy
No Intervention: Control
Healthy group with neither Diabetes nor Periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF levels of IL-39 & IL35
Time Frame: 3 months
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis
3 months
Effect of SRP on GCF levels of IL-39 & IL35
Time Frame: 3 MONTHS
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis after Scaling & root planning
3 MONTHS

Collaborators and Investigators

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

Sponsor

Fayoum University

Investigators

  • Principal Investigator: sandy Hassan, ass.prof, Associate Professor

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)

January 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #REC-FDBSU/06102022-02/HS

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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