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

Not Applicable

Completed

• Conditions: Periodontitis Generalized

• Registration Number: NCT06539039
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes	8 weeks	To detect difference in the ratio of the proinflammatory cytokine tumor necrosis factor-α to the anti-inflammatory cytokine interleukin-10 between periodontitis patients with and without type 2 diabetes mellitus before and after non surgical periodontal therapy.

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Cairo, Organization Of African Unity St, El-Qobba Bridge, Egypt