Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Procedure: non-surgical periodontal therapy

• Registration Number: NCT04473209
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-09-30
• Study Completion: 2020-01-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-14
• Last Update Submitted: 2020-07-14
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-diabetic group	non-surgical periodontal therapy	non diabetic patients with chronic periodontitis
diabetic group	non-surgical periodontal therapy	diabetic patients with chronic periodontitis

Primary Outcome Measures

Name	Time	Method
serum resistin	3 months	ng/ml

Secondary Outcome Measures

Name	Time	Method
probing pocket depth	3 months	mm
C-reactive protein	3 months	μg/mL
clinical attachment loss	3 months	mm

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt