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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus With Periodontal Disease
• Intervention / Treatment: Drug: Doxycycline Group; Drug: placebo topical gel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Group A; Doxycycline 3% topical gel
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 Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal pocket	Periodontal probe	15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amirhossein Farahmand

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Mouth Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Periodontal Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES