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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05880654
Enrollment
57
Registered
2023-05-30
Start date
2023-01-01
Completion date
2023-05-15
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Periodontal Disease, AVDC Stage 3

Keywords

Periodontitis & Diabetes mellitus

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.

Interventions

PROCEDUREScaling & root planning

Non Surgical periodontal therapy

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Chronic periodontitis group chronic periodontitis with diabetes control group

Eligibility

Sex/Gender
ALL
Age
35 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
GCF levels of IL-39 & IL353 monthsGingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis
Effect of SRP on GCF levels of IL-39 & IL353 MONTHSGingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis after Scaling & root planning

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026