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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Periodontal Disease, AVDC Stage 3

Intervention / Treatment
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* Procedure: Scaling & root planning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Chronic periodontitis group chronic periodontitis with diabetes control group
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis & Diabetes mellitus