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

Not Applicable

Completed

• Conditions: Generalized Periodontal Disease, AVDC Stage 3
• Interventions: Procedure: Scaling & root planning

• Registration Number: NCT05880654
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-04-30
• Status Verified: 2023-05
• Study Completion: 2023-05-15
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemically healthy periodontitis	Scaling & root planning	Non Surgical Periodontal therapy ( Scaling \& Root planning)
Diabetic & Periodontitis	Scaling & root planning	Non surgical periodontal therapy ( scaling \& root planning)

Primary Outcome Measures

Name	Time	Method
GCF levels of IL-39 & IL35	3 months	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	3 MONTHS	Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis after Scaling \& root planning

Trial Locations

Locations (2)

Sandy hassan shaaban; 🇪🇬 Cairo, Egypt

Sandy hassan; 🇪🇬 Cairo, Virginia, Egypt