The Effect of Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®
Primary Purpose
Diabetes Mellitus With Periodontal Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Doxycycline Group
placebo topical gel
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
doxycycline gel
placebo gel
Arm Description
Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
placebo topical gel was put into the periodontal pocket using an insulin syringe
Outcomes
Primary Outcome Measures
Periodontal pocket
Periodontal probe
Secondary Outcome Measures
glycated hemoglobin (HbA1c)
Blood test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02735837
Brief Title
The Effect of Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®
Official Title
The Effect of Non-Surgical Periodontal Therapy With Adjunctive Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus (DM):A Randomized, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amirhossein Farahmand
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 subgingivally doxycycline gel 3% 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 gel for 15 days; and "Group 2": (12 patients) has the same treatment but with placebo gel, 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
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxycycline gel
Arm Type
Active Comparator
Arm Description
Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
Arm Title
placebo gel
Arm Type
Placebo Comparator
Arm Description
placebo topical gel was put into the periodontal pocket using an insulin syringe
Intervention Type
Drug
Intervention Name(s)
Doxycycline Group
Other Intervention Name(s)
Doxycycline 3% topical gel, Group A
Intervention Description
Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
Intervention Type
Drug
Intervention Name(s)
placebo topical gel
Other Intervention Name(s)
Group B
Intervention Description
placebo topical gel was put into the periodontal pocket using an insulin syringe
Primary Outcome Measure Information:
Title
Periodontal pocket
Description
Periodontal probe
Time Frame
15 days
Secondary Outcome Measure Information:
Title
glycated hemoglobin (HbA1c)
Description
Blood test
Time Frame
3 months
10. Eligibility
Sex
All
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 Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®
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