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

NCT ID: NCT06539039

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

Periodontitis Generalized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

periodontitis with controlled diabetes

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

Group Type: EXPERIMENTAL

non surgical periodontal therapy

Intervention Type: PROCEDURE

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

periodontitis with poorly controlled diabetes

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

Group Type: EXPERIMENTAL

non surgical periodontal therapy

Intervention Type: PROCEDURE

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

periodontitis

patients with generalized periodontitis

Group Type: EXPERIMENTAL

non surgical periodontal therapy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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 .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mahetab mohamed, lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Dentistry

Cairo, Organization of African Unity St, El-Qobba Bridge, Egypt

Countries

Egypt

Other Identifiers

fDASU-RecIM210223

Identifier Type: -

Identifier Source: org_study_id