The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus With Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doxycycline Group
placebo Group
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus With Periodontal Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis
- Minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - Had a glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening
- Had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes.
Exclusion Criteria:
- Pregnancy or lactation
- History of allergy to drugs used in the study
- Smoking
- Diabetes-related emergency within 30 days ago
- Use of nonsteroidal anti-inflammatory drugs
- Or taking low dose daily aspirin (75-325 mg)\
- Use of immunosuppressive medications; antibiotic use
- Dialysis
- Risk of bleeding complications
- The type of disease periodontal (Aggressive)
- A history of periodontal treatment in the previous 6 months
- Orthodontic treatment
- Using the removal prostheses
- Extensive dental caries
- Dental abscesses or infections.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
oral doxycycline
oral placebo capsule
Arm Description
Oral capsules of doxycycline 100 mg were used
oral placebo capsule were used
Outcomes
Primary Outcome Measures
Periodontal pocket depth
Periodontal Probes Measuring (millimeters)
Secondary Outcome Measures
glycated hemoglobin (HbA1c)
Blood test
Full Information
NCT ID
NCT02845024
First Posted
May 24, 2016
Last Updated
September 30, 2016
Sponsor
Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT02845024
Brief Title
The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus
Official Title
The Effects of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus: A Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim:
The purpose of this study is to investigate the effect of nonsurgical periodontal therapy plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who have periodontitis.
Materials and methods:
A total of 24 type 2 DM patients with periodontitis will be selected for the study, and randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than 110 have), and also with periodontal disease are chronic moderate (at least in three areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical examination and radiographic signs are being); Takes place. The initial HbA1c Patients should be between 7-9 percent over the past three months has changed his medication also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group 1": (12 patients) was treated with oral hygiene instruction, Scaling, and root planing, and doxycycline for 15 days; and "Group 2": (12 patients) has the same treatment but with placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.
Detailed Description
Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive enzymes in periodontal disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus With Periodontal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral doxycycline
Arm Type
Active Comparator
Arm Description
Oral capsules of doxycycline 100 mg were used
Arm Title
oral placebo capsule
Arm Type
Placebo Comparator
Arm Description
oral placebo capsule were used
Intervention Type
Drug
Intervention Name(s)
Doxycycline Group
Other Intervention Name(s)
Group A
Intervention Description
Oral doxycycline 100mg was taken within 15 days
Intervention Type
Drug
Intervention Name(s)
placebo Group
Other Intervention Name(s)
Group B
Intervention Description
Oral placebo was taken within 15 days
Primary Outcome Measure Information:
Title
Periodontal pocket depth
Description
Periodontal Probes Measuring (millimeters)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
glycated hemoglobin (HbA1c)
Description
Blood test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis
Minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - Had a glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening
Had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes.
Exclusion Criteria:
Pregnancy or lactation
History of allergy to drugs used in the study
Smoking
Diabetes-related emergency within 30 days ago
Use of nonsteroidal anti-inflammatory drugs
Or taking low dose daily aspirin (75-325 mg)\
Use of immunosuppressive medications; antibiotic use
Dialysis
Risk of bleeding complications
The type of disease periodontal (Aggressive)
A history of periodontal treatment in the previous 6 months
Orthodontic treatment
Using the removal prostheses
Extensive dental caries
Dental abscesses or infections.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus
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