Dentistry
Cairo, Organization of African Unity St, El-Qobba Bridge, 11566, Egypt
Completed
NCT Number: NCT06539039
Periodontal Therapy Effect on the Ratio of TNF-α to IL-10 in Periodontis With/Out DM
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 .
Treatment and study plan
Non surgical periodontal therapy
Procedureparticipants 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
Primary outcomes
-
detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Official study title
The Effect of Non Surgical Periodontal Therapy on the Ratio of TNF-α to IL-10 in Periodontitis Patients With Diabetics Mellites
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Aug 6, 2024
- Registry last updated
- Aug 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.