Effect of Non Surgical Treatment of Periodontitis on Diabetes Control (PARODIA1)
July 17, 2016 updated by: Sobngwi Eugene, Yaounde Central Hospital
Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Yaounde, Cameroon
- National Obesity Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: treatment
immediate non-surgical periodontal treatment
|
full-mouth scaling and root planing
|
|
Other: control
non-surgical periodontal treatment scheduled for the following 3-monthly visit
|
full-mouth scaling and root planing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic
Time Frame: 3 months
|
Change in HbA1c
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation
Time Frame: 3 months
|
change in CRP level between baseline and 3-month post intervention
|
3 months
|
|
Periodontal 1
Time Frame: 3 months
|
Change in plaque index between baseline and 3-month post intervention
|
3 months
|
|
Periodontal 2
Time Frame: 3 months
|
Change in bleeding index between baseline and 3-month post intervention
|
3 months
|
|
Periodontal 3
Time Frame: 3 months
|
Change in pocket depth between baseline and 3-month post intervention
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
April 16, 2016
First Submitted That Met QC Criteria
April 16, 2016
First Posted (Estimate)
April 20, 2016
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 17, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNO20154
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