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

The Effect of Non Surgical Periodontal Therapy on the Ratio of TNF-α to IL-10 in Periodontitis Patients With Diabetics Mellites

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis Generalized
• Intervention / Treatment: Procedure: non surgical periodontal therapy

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Organization Of African Unity St, El-Qobba Bridge
    • Cairo, Organization Of African Unity St, El-Qobba Bridge, Egypt, 11566
      • Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontitis with controlled diabetes; patients with generalized periodontitis and controlled diabetes mellitus with glycated haemoglobin (HbA1c) less than 7%.	Procedure: non surgical periodontal therapy; participants received full mouth one stage debridement using hand instruments and use of universal curette for sub gingival debridement and ultrasonic scalers through use of supragingival and subgingival ultrasonic tips
Experimental: periodontitis with poorly controlled diabetes; patients with generalized periodontitis, and poorly controlled diabetes mellitus with HbA1c more than or equal 7%.	Procedure: non surgical periodontal therapy; participants received full mouth one stage debridement using hand instruments and use of universal curette for sub gingival debridement and ultrasonic scalers through use of supragingival and subgingival ultrasonic tips
Experimental: periodontitis; patients with generalized periodontitis	Procedure: non surgical periodontal therapy; participants received full mouth one stage debridement using hand instruments and use of universal curette for sub gingival debridement and ultrasonic scalers through use of supragingival and subgingival ultrasonic tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes	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.	8 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: mahetab mohamed, lecturer, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: fDASU-RecIM210223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No