Periodontal Therapy Effect on the Ratio of TNF-α to IL-10 in Periodontis With/Out DM

Ain Shams University

Status: Completed

Conditions: Periodontitis Generalized

Treatments: Procedure: non surgical periodontal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06539039

fDASU-RecIM210223

Details and patient eligibility

About

Periodontitis is a chronic inflammatory disease affecting the periodontium, characterized by irreversible damage to the gingiva, periodontal ligament, and alveolar bone. It is prevalent among adults, significantly impacting oral health and quality of life. This study investigates the effect of non-surgical periodontal therapy (NSPT) on the levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10) in periodontitis patients with and without diabetes mellitus type II.

Full description

A single-blinded, randomized clinical trial was conducted on 36 patients with generalized periodontitis, recruited from Ain-Shams University's outpatient clinic. Patients were divided into three groups: poorly controlled diabetes with periodontitis (HbA1c ≥ 7%), controlled diabetes with periodontitis (HbA1c < 7%), and non-diabetic periodontitis. Full-mouth NSPT was performed, and clinical parameters (Plaque Index, Bleeding Index, Pocket Depth, Clinical Attachment Level) were assessed at baseline and eight weeks post-treatment. Venous blood samples were collected to measure TNF-α and IL-10 levels using ELISA kits.

Enrollment: 36 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Both genders. Age (20-50 ) years old. Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.

Generalized Periodontitis patients . Having at least 20 tooth excluding wisdoms. Systemically free according to the modified Burkett's health history questionnaire except for diabetes mellitus (Burket, Greenberg and Glick 2003).

Exclusion criteria

• Smokers.
• Intake of immunosuppressive drugs, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study .
• status of pregnancy or lactation.
• allergy to local anesthetic.
• Prisoners .
• The vulnerable group ; mentally and physically disabled patients .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

periodontitis with controlled diabetes

Experimental group

Description:

patients with generalized periodontitis and controlled diabetes mellitus with glycated haemoglobin (HbA1c) less than 7%.

Treatment:

Procedure: non surgical periodontal therapy

periodontitis with poorly controlled diabetes

Experimental group

Description:

patients with generalized periodontitis, and poorly controlled diabetes mellitus with HbA1c more than or equal 7%.

Treatment:

Procedure: non surgical periodontal therapy

periodontitis

Experimental group

Description:

patients with generalized periodontitis

Treatment:

Procedure: non surgical periodontal therapy