- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03908606
Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
April 8, 2019 updated by: Gihane Gharib Madkour, Cairo University
Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 12411
- Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diabetic patients type 2
- Periodontitis patients
Exclusion Criteria:
- Smokers
- Pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Periodontitis patients with diabetes type 2
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
|
Supra and subgingival scaling and root planing.
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Experimental: Periodontitis patients
scaling and root planing will be done to periodontitis patients.
Serum samples were collected before and after treatment to assess hs-CRP levels.
|
Supra and subgingival scaling and root planing.
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No Intervention: Healthy control group
We measured serum levels of hs-CRP in all healthy control subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical attachment level
Time Frame: 3 months
|
gain in clinical attachment level
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gihane Madkour, Prof, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2018
Primary Completion (Actual)
January 2, 2019
Study Completion (Actual)
January 2, 2019
Study Registration Dates
First Submitted
April 6, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 8, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1281976
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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