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

Fayoum University

Status: Completed

Conditions: Generalized Periodontal Disease, AVDC Stage 3

Treatments: Procedure: Scaling & root planning

Study type: Interventional

Funder types: Other

Identifiers

NCT05880654

#REC-FDBSU/06102022-02/HS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Systemically healthy periodontitis

Active Comparator group

Description:

Non Surgical Periodontal therapy ( Scaling \& Root planning)

Treatment:

Procedure: Scaling & root planning

Diabetic & Periodontitis

Active Comparator group

Description:

Non surgical periodontal therapy ( scaling \& root planning)

Treatment:

Procedure: Scaling & root planning

Control

No Intervention group

Description:

Healthy group with neither Diabetes nor Periodontitis