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Completed

NCT Number: NCT02735837

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

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.

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Key information

Conditions

Diabetes Mellitus With Periodontal Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline Group

Drug

Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe

Other names: Doxycycline 3% topical gel, Group A

Placebo Topical Gel

Drug

placebo topical gel was put into the periodontal pocket using an insulin syringe

Other names: Group B

Primary outcomes

  1. Periodontal pocket

    Time frame: 15 days

    Periodontal probe

Secondary outcomes

  1. glycated hemoglobin (HbA1c)

    Time frame: 3 months

    Blood test

Sponsors and collaborators

Lead sponsor

Amirhossein Farahmand

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2016
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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