The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus

September 30, 2016 updated by: Amirhossein Farahmand, Islamic Azad University, Tehran

The Effects of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus: A Randomized Clinical Trials

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral doxycycline
Oral capsules of doxycycline 100 mg were used
Drug: Doxycycline Group
Oral doxycycline 100mg was taken within 15 days
Other Names:
  • Group A
Placebo Comparator: oral placebo capsule
oral placebo capsule were used
Drug: placebo Group
Oral placebo was taken within 15 days
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal pocket depth
Time Frame: 15 days
Periodontal Probes Measuring (millimeters)
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycated hemoglobin (HbA1c)
Time Frame: 3 months
Blood test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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