Back to resultsEffect of Non Surgical Treatment of Periodontitis on Diabetes Control (PARODIA1)
Primary Purpose
Periodontitis, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, diabetes, HbA1c, inflammation
Eligibility Criteria
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
Sites / Locations
- National Obesity Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
treatment
control
Arm Description
immediate non-surgical periodontal treatment
non-surgical periodontal treatment scheduled for the following 3-monthly visit
Outcomes
Primary Outcome Measures
Metabolic
Change in HbA1c
Secondary Outcome Measures
Inflammation
change in CRP level between baseline and 3-month post intervention
Periodontal 1
Change in plaque index between baseline and 3-month post intervention
Periodontal 2
Change in bleeding index between baseline and 3-month post intervention
Periodontal 3
Change in pocket depth between baseline and 3-month post intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02745015
Brief Title
Effect of Non Surgical Treatment of Periodontitis on Diabetes Control
Acronym
PARODIA1
Official Title
Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon
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
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yaounde Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Diabetes
Keywords
periodontitis, diabetes, HbA1c, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
immediate non-surgical periodontal treatment
Arm Title
control
Arm Type
Other
Arm Description
non-surgical periodontal treatment scheduled for the following 3-monthly visit
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
full-mouth scaling and root planing
Primary Outcome Measure Information:
Title
Metabolic
Description
Change in HbA1c
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inflammation
Description
change in CRP level between baseline and 3-month post intervention
Time Frame
3 months
Title
Periodontal 1
Description
Change in plaque index between baseline and 3-month post intervention
Time Frame
3 months
Title
Periodontal 2
Description
Change in bleeding index between baseline and 3-month post intervention
Time Frame
3 months
Title
Periodontal 3
Description
Change in pocket depth between baseline and 3-month post intervention
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Obesity Centre
City
Yaounde
Country
Cameroon
12. IPD Sharing Statement
Citations:
PubMed Identifier
29482543
Citation
Tsobgny-Tsague NF, Lontchi-Yimagou E, Nana ARN, Tankeu AT, Katte JC, Dehayem MY, Bengondo CM, Sobngwi E. Effects of nonsurgical periodontal treatment on glycated haemoglobin on type 2 diabetes patients (PARODIA 1 study): a randomized controlled trial in a sub-Saharan Africa population. BMC Oral Health. 2018 Feb 26;18(1):28. doi: 10.1186/s12903-018-0479-5.
Results Reference
derived
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Effect of Non Surgical Treatment of Periodontitis on Diabetes Control
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