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The Effect of Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®

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ClinicalTrials.gov Identifier: NCT02735837
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Amirhossein Farahmand, Islamic Azad University, Tehran

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus With Periodontal Disease Drug: Doxycycline Group Drug: placebo topical gel Phase 2 Phase 3

Detailed Description:
Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive enzymes in periodontal disease

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: doxycycline gel
Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
Drug: Doxycycline Group
Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
Other Names:
  • Doxycycline 3% topical gel
  • Group A

Placebo Comparator: placebo gel
placebo topical gel was put into the periodontal pocket using an insulin syringe
Drug: placebo topical gel
placebo topical gel was put into the periodontal pocket using an insulin syringe
Other Name: Group B




Primary Outcome Measures :
  1. Periodontal pocket [ Time Frame: 15 days ]
    Periodontal probe


Secondary Outcome Measures :
  1. glycated hemoglobin (HbA1c) [ Time Frame: 3 months ]
    Blood test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Amirhossein Farahmand, The effect of non-surgical periodontal therapy with adjunctive topical doxycycline gel on HbA1c in patients with type 2 diabetes mellitus (DM)., Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT02735837    
Other Study ID Numbers: 560
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Periodontal Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents