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Serum Hs-CRP in Periodontitis Patients With or Without Diabetes

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ClinicalTrials.gov Identifier: NCT03908606
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gihane Gharib Madkour, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Diabetes Mellitus, Type 2 Procedure: Scaling and root planing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Procedure: Scaling and root planing
Supra and subgingival scaling and root planing.
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.
 Procedure: Scaling and root planing
Supra and subgingival scaling and root planing.
No Intervention: Healthy control group
We measured serum levels of hs-CRP in all healthy control subjects


Outcome Measures
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Primary Outcome Measures :
  1. clinical attachment level [ Time Frame: 3 months ]
    gain in clinical attachment level


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diabetic patients type 2
  2. Periodontitis patients

Exclusion Criteria:

  1. Smokers
  2. Pregnant females
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908606


Locations
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Egypt
Cairo University
Cairo, Egypt, 12411
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Gihane Madkour, Prof Cairo University
More Information
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Responsible Party: Gihane Gharib Madkour, Associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT03908606    
Other Study ID Numbers: 1281976
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases