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

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.

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Key information

Conditions

Generalized Periodontal Disease, AVDC Stage 3 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandy hassan, Cairo, Virginia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling & root planning

Procedure

Non Surgical periodontal therapy

Primary outcomes

GCF levels of IL-39 & IL35

Time frame: 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

Time frame: 3 MONTHS

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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 30, 2023
Registry last updated: May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed