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

Diabetes Mellitus With Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845024
• Other study ID #: 515
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: September 30, 2016
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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 a 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus With Periodontal Disease
• Diabetes Mellitus, Type 2
• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Doxycycline Group
Oral doxycycline 100mg was taken within 15 days
• placebo Group
Oral placebo was taken within 15 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal pocket depth	Periodontal Probes Measuring (millimeters)	15 days	Yes
Secondary	glycated hemoglobin (HbA1c)	Blood test	3 months	Yes