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

Primary Purpose

Generalized Periodontal Disease, AVDC Stage 3

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scaling & root planning
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Periodontal Disease, AVDC Stage 3 focused on measuring Periodontitis & Diabetes mellitus

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Stage III Grade C Generalized periodontitis with diabetes Stage III grade B Generalized periodontitis in systemic healthy subjects Exclusion Criteria: Patients treated with any type of medications and/ or antibiotics during the past 3 months, Pregnancy Lactation Receiving professional periodontal treatment during the past 6 months Current or former smokers

Sites / Locations

  • Sandy hassan
  • Sandy hassan shaaban

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Systemically healthy periodontitis

Diabetic & Periodontitis

Control

Arm Description

Non Surgical Periodontal therapy ( Scaling & Root planning)

Non surgical periodontal therapy ( scaling & root planning)

Healthy group with neither Diabetes nor Periodontitis

Outcomes

Primary Outcome Measures

GCF levels of IL-39 & IL35
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis
Effect of SRP on GCF levels of IL-39 & IL35
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis after Scaling & root planning

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
May 19, 2023
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05880654
Brief Title
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
Official Title
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Periodontal Disease, AVDC Stage 3
Keywords
Periodontitis & Diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Chronic periodontitis group chronic periodontitis with diabetes control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systemically healthy periodontitis
Arm Type
Active Comparator
Arm Description
Non Surgical Periodontal therapy ( Scaling & Root planning)
Arm Title
Diabetic & Periodontitis
Arm Type
Active Comparator
Arm Description
Non surgical periodontal therapy ( scaling & root planning)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy group with neither Diabetes nor Periodontitis
Intervention Type
Procedure
Intervention Name(s)
Scaling & root planning
Intervention Description
Non Surgical periodontal therapy
Primary Outcome Measure Information:
Title
GCF levels of IL-39 & IL35
Description
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis
Time Frame
3 months
Title
Effect of SRP on GCF levels of IL-39 & IL35
Description
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis after Scaling & root planning
Time Frame
3 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Stage III Grade C Generalized periodontitis with diabetes Stage III grade B Generalized periodontitis in systemic healthy subjects Exclusion Criteria: Patients treated with any type of medications and/ or antibiotics during the past 3 months, Pregnancy Lactation Receiving professional periodontal treatment during the past 6 months Current or former smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sandy Hassan, ass.prof
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandy hassan
City
Cairo
State/Province
Virginia
ZIP/Postal Code
22039
Country
Egypt
Facility Name
Sandy hassan shaaban
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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