Back to resultsSerum Hs-CRP in Periodontitis Patients With or Without Diabetes
Primary Purpose
Periodontal Disease, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Disease
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients type 2
- Periodontitis patients
Exclusion Criteria:
- Smokers
- Pregnant females
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Periodontitis patients with diabetes type 2
Periodontitis patients
Healthy control group
Arm Description
scaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment
scaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels.
We measured serum levels of hs-CRP in all healthy control subjects
Outcomes
Primary Outcome Measures
clinical attachment level
gain in clinical attachment level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03908606
Brief Title
Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
Official Title
Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
January 2, 2019 (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
the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.
Detailed Description
Periodontitis and diabetes are chronic disorders with a two-way correlation as they can both stimulate an inflammatory response with subsequent formation of inflammatory mediators and cytokines. C reactive protein is an inflammatory plasma marker having a role in the systemic reaction to inflammation. thus, our aim in the current study was to evaluate serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. A total of 60 patients were enrolled in this study. ELISA was used for determination of hs- CRP. Non- surgical periodontal therapy was carried out for all periodontitis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontitis patients with diabetes type 2
Arm Type
Experimental
Arm Description
scaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment
Arm Title
Periodontitis patients
Arm Type
Experimental
Arm Description
scaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
We measured serum levels of hs-CRP in all healthy control subjects
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Supra and subgingival scaling and root planing.
Primary Outcome Measure Information:
Title
clinical attachment level
Description
gain in clinical attachment level
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diabetic patients type 2
Periodontitis patients
Exclusion Criteria:
Smokers
Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihane Madkour, Prof
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
12411
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
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