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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
Amirhossein Farahmand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus With Periodontal Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 30, 2016
    Last Updated
    July 2, 2019
    Sponsor
    Amirhossein Farahmand
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    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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