Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects

Periodontitis Clinical Trial

— PARODIA2  

Official title:

Effects of Non-surgical Treatment of Chronic Periodontitis on Insulin Resistance and Glucose Tolerance in Non-diabetic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830113
• Other study ID #: CNO20155
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: July 8, 2016
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Periodontitis
• Glucose Intolerance
• Insulin Resistance
• Periodontitis
• Prediabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yaounde Central Hospital	University of Yaounde 1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	change in 2-hour post load blood glucose	3 months	No
Primary	Insulin sensitivity	change in glucose disappearance rate during the short insulin tolerance test	3 months	No
Secondary	Composite periodontal health	Change in plaque index, gingival bleeding index, pocket depth, and clinical attachment loss	3 months	No
Secondary	Inflammation	change in Serum CRP	3 months	No