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

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
non-surgical periodontal therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

diabetic group

non-diabetic group

Arm Description

diabetic patients with chronic periodontitis

non diabetic patients with chronic periodontitis

Outcomes

Primary Outcome Measures

serum resistin
ng/ml

Secondary Outcome Measures

C-reactive protein
μg/mL
probing pocket depth
mm
clinical attachment loss
mm

Full Information

First Posted
July 12, 2020
Last Updated
July 14, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04473209
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diabetic group
Arm Type
Active Comparator
Arm Description
diabetic patients with chronic periodontitis
Arm Title
non-diabetic group
Arm Type
Active Comparator
Arm Description
non diabetic patients with chronic periodontitis
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal therapy
Intervention Description
supra and subgingival debridement
Primary Outcome Measure Information:
Title
serum resistin
Description
ng/ml
Time Frame
3 months
Secondary Outcome Measure Information:
Title
C-reactive protein
Description
μg/mL
Time Frame
3 months
Title
probing pocket depth
Description
mm
Time Frame
3 months
Title
clinical attachment loss
Description
mm
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

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

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