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

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT05880654
Collaborator
(none)
57
2
3
4.4
28.5
6.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Scaling & root planning
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Chronic periodontitis group chronic periodontitis with diabetes control groupChronic periodontitis group chronic periodontitis with diabetes control group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
May 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. GCF levels of IL-39 & IL35 [3 months]

    Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis

  2. Effect of SRP on GCF levels of IL-39 & IL35 [3 MONTHS]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sandy hassan Cairo Virginia Egypt 22039
2 Sandy hassan shaaban Cairo Egypt

Sponsors and Collaborators

  • Fayoum University

Investigators

  • Principal Investigator: sandy Hassan, ass.prof, associate professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandy Hassan, Associate professor oral medicine & periodontology departement, Fayoum University
ClinicalTrials.gov Identifier:
NCT05880654
Other Study ID Numbers:
  • #REC-FDBSU/06102022-02/HS
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sandy Hassan, Associate professor oral medicine & periodontology departement, Fayoum University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023