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

Type2 Diabetes Clinical Trial

Official title:

The Effect of Non-surgical Periodontal Therapy on Serum Resistin Level in Chronic Periodontitis Patients With or Without Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473209
• Other study ID #: version 1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus, Type 2
• Periodontitis
• Type2 Diabetes

Intervention

Procedure:
• non-surgical periodontal therapy
supra and subgingival debridement

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum resistin	ng/ml	3 months
Secondary	C-reactive protein	µg/mL	3 months
Secondary	probing pocket depth	mm	3 months
Secondary	clinical attachment loss	mm	3 months