Effect of Non Surgical Treatment of Periodontitis on Diabetes Control

Diabetes Clinical Trial

— PARODIA1  

Official title:

Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745015
• Other study ID #: CNO20154
• Status: Completed
• Phase: N/A
• First received: April 16, 2016
• Last updated: July 17, 2016
• Start date: December 2014
• Est. completion date: May 2015

Study information

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

Clinical Trial Summary

The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.

Description:

The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes for at least one year

• periodontitis

• HbA1c > 7%

Exclusion Criteria:

• Periodontal treatment in the last 6 months

• antibiotics in the last 3 months

• tobacco smoking

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Periodontitis

Intervention

Procedure:
• non-surgical periodontal treatment
full-mouth scaling and root planing

Locations

Country	Name	City	State
Cameroon	National Obesity Centre	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic	Change in HbA1c	3 months	No
Secondary	Inflammation	change in CRP level between baseline and 3-month post intervention	3 months	No
Secondary	Periodontal 1	Change in plaque index between baseline and 3-month post intervention	3 months	No
Secondary	Periodontal 2	Change in bleeding index between baseline and 3-month post intervention	3 months	No
Secondary	Periodontal 3	Change in pocket depth between baseline and 3-month post intervention	3 months	No