Back to resultsThe Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
Primary Purpose
Chronic Periodontitis, Generalized
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amoxicillin 500mg and metronidazole 400mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis, Generalized
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis
Exclusion Criteria:
Pregnancy
- Alcoholism and smoking
- Presence of any systemic disorders other than hypertension and diabetes
- Diabetic major complications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
test group
control group
Arm Description
Metronidazole 400mg,three times daily for two weeks Amoxicillin 500mg,three times daily for two weeks.
no intervention during study period
Outcomes
Primary Outcome Measures
glycosylated haemoglobin (HbA1c)
Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03783845
Brief Title
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
Official Title
The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
March 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taibah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?
Detailed Description
The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.
Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Generalized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
Metronidazole 400mg,three times daily for two weeks
Amoxicillin 500mg,three times daily for two weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention during study period
Intervention Type
Combination Product
Intervention Name(s)
amoxicillin 500mg and metronidazole 400mg
Other Intervention Name(s)
Amoxil and Flagyl
Intervention Description
metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
Primary Outcome Measure Information:
Title
glycosylated haemoglobin (HbA1c)
Description
Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis
Exclusion Criteria:
Pregnancy
Alcoholism and smoking
Presence of any systemic disorders other than hypertension and diabetes
Diabetic major complications
12. IPD Sharing Statement
Learn more about this trial
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
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