Clinical trial NCT04473209: Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis
Official title: The Effect of Non-surgical Periodontal Therapy on Serum Resistin Level in Chronic Periodontitis Patients With or Without Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis
Primary purpose: TREATMENT

Brief summary: non-surgical periodontal debridement was performed for diabetic patients with chronic periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum resistin level was assessed in the two groups before and after periodontal therapy and also was compared to a healthy control group.

Detailed description: Background: Resisitin is a recognized marker for chronic inflammatory conditions that could be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum resistin level in type 2 diabetic patients with chronic periodontitis.

Methods: Forty individuals were recruited in this study and were divided into three groups, diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic individuals with healthy periodontium. Non-surgical periodontal therapy with supra and subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth, clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity C-Reactive Protein assay were recorded for both groups before and after treatment, while HbA1c was recorded for the diabetic group.

Eligibility criteria: Inclusion Criteria:

* diagnosed with moderate to severe chronic periodontitis.
* Presence of a minimum of 15 natural teeth
* Presence of at least four teeth with one or more sites with probing pocket depth (PPD) ≥5mm and clinical attachment level (CAL) ≥4mm
* agreement to participate in the study and sign a written informed consent

Exclusion Criteria:

* Patients who received any periodontal treatment or professional scaling and root planing of the teeth for at least 6 months prior to the study initiation
* A history of antibiotics therapy and anti-inflammatory drugs within the previous 6 months
* Pregnancy or use of contraceptives or any medication related to diabetes
* former or current smokers ˂ 5 years.

Primary outcomes:
measure: serum resistin
timeFrame: 3 months
Secondary outcomes:
measure: C-reactive protein
timeFrame: 3 months
measure: probing pocket depth
timeFrame: 3 months
measure: clinical attachment loss
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: