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Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects (PARODIA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830113
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
University of Yaounde 1
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

Brief Summary:
This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.

Condition or disease Intervention/treatment Phase
Periodontitis Prediabetes Procedure: non-surgical periodontal treatment Not Applicable

Detailed Description:
Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT) consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT, glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry will be measured before and 3 months after the NSPT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: non-surgical periodontal treatment
One session of non-surgical periodontal treatment consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution.
Procedure: non-surgical periodontal treatment
One session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution




Primary Outcome Measures :
  1. Glucose tolerance [ Time Frame: 3 months ]
    change in 2-hour post load blood glucose

  2. Insulin sensitivity [ Time Frame: 3 months ]
    change in glucose disappearance rate during the short insulin tolerance test


Secondary Outcome Measures :
  1. Composite periodontal health [ Time Frame: 3 months ]
    Change in plaque index, gingival bleeding index, pocket depth, and clinical attachment loss

  2. Inflammation [ Time Frame: 3 months ]
    change in Serum CRP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic periodontitis
  • Non diabetic individual

Exclusion Criteria:

  • Known diabetes
  • Periodontal treatment less than 6 months prior to inclusion
  • Having less than 20 natural teeth

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): NCT02830113


Sponsors and Collaborators
Yaounde Central Hospital
University of Yaounde 1
Investigators
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Principal Investigator: Eugene Sobngwi, MD, PhD University of Yaoundé 1 and Yaoundé Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sobngwi Eugene, Professor of Endocrinology and Diabetes, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT02830113    
Other Study ID Numbers: CNO20155
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
periodontitis
diabetes
prevention
impaired glucose tolerance
insulin resistance
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases