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

NCT06539039 | Completed DMC

• 1 other identifier: fDASU-RecIM210223
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis Generalized

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

periodontitis with controlled diabetes

EXPERIMENTAL

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

Procedure: non surgical periodontal therapy

periodontitis with poorly controlled diabetes

EXPERIMENTAL

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

Procedure: non surgical periodontal therapy

periodontitis

EXPERIMENTAL

patients with generalized periodontitis

Procedure: non surgical periodontal therapy

Interventions

non surgical periodontal therapy 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; periodontitis with controlled diabetes; periodontitis with poorly controlled diabetes

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Dentistry

Cairo, Organization of African Unity St, El-Qobba Bridge, 11566, Egypt

Location

Study Officials

• mahetab mohamed, lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 36 patients with generalized periodontitis, recruited from Ain-Shams University's outpatient clinic. Patients were divided into three groups: poorly controlled diabetes (HbA1c ≥ 7%), controlled diabetes (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 Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)