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
About this trial
This is an interventional treatment trial for Type2 Diabetes
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.
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
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
Learn more about this trial
Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis
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