Clinical trial NCT06539039: Periodontal Therapy Effect on the Ratio of TNF-α to IL-10 in Periodontis With/Out DM
Official title: The Effect of Non Surgical Periodontal Therapy on the Ratio of TNF-α to IL-10 in Periodontitis Patients With Diabetics Mellites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis Generalized
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry
state: Organization Of African Unity St, El-Qobba Bridge
Study officials:
affiliation: Ain Shams University
name: mahetab mohamed, lecturer
role: PRINCIPAL_INVESTIGATOR
References: