Back to resultsMetabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects (PARODIA2)
Primary Purpose
Periodontitis, Prediabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring periodontitis, diabetes, prevention, impaired glucose tolerance, insulin resistance
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-surgical periodontal treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Glucose tolerance
change in 2-hour post load blood glucose
Insulin sensitivity
change in glucose disappearance rate during the short insulin tolerance test
Secondary Outcome Measures
Composite periodontal health
Change in plaque index, gingival bleeding index, pocket depth, and clinical attachment loss
Inflammation
change in Serum CRP
Full Information
NCT ID
NCT02830113
First Posted
July 8, 2016
Last Updated
July 8, 2016
Sponsor
Yaounde Central Hospital
Collaborators
University of Yaounde 1
1. Study Identification
Unique Protocol Identification Number
NCT02830113
Brief Title
Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects
Acronym
PARODIA2
Official Title
Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yaounde Central Hospital
Collaborators
University of Yaounde 1
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Prediabetes
Keywords
periodontitis, diabetes, prevention, impaired glucose tolerance, insulin resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-surgical periodontal treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
One session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
change in 2-hour post load blood glucose
Time Frame
3 months
Title
Insulin sensitivity
Description
change in glucose disappearance rate during the short insulin tolerance test
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Composite periodontal health
Description
Change in plaque index, gingival bleeding index, pocket depth, and clinical attachment loss
Time Frame
3 months
Title
Inflammation
Description
change in Serum CRP
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Sobngwi, MD, PhD
Organizational Affiliation
University of Yaoundé 1 and Yaoundé Central Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34261767
Citation
Nana Nana AR, Tsobgny Tsague NF, Lontchi-Yimagou E, Bengondo Messanga C, Tankeu A, Katte JC, Balti Vounsia E, Dehayem M, Sobngwi E. Effects of non-surgical treatment of chronic periodontitis on insulin resistance and glucose tolerance in subjects without diabetes (PARODIA 2 study). J Investig Med. 2021 Oct;69(7):1377-1381. doi: 10.1136/jim-2021-001831. Epub 2021 Jul 14.
Results Reference
derived
Learn more about this trial
Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects
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