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

NCT ID: NCT02845024

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-07-31

Brief 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.

Detailed Description

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

Conditions

Diabetes Mellitus With Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

oral doxycycline

Oral capsules of doxycycline 100 mg were used

Group Type: ACTIVE_COMPARATOR

Doxycycline Group

Intervention Type: DRUG

Oral doxycycline 100mg was taken within 15 days

oral placebo capsule

oral placebo capsule were used

Group Type: PLACEBO_COMPARATOR

placebo Group

Intervention Type: DRUG

Oral placebo was taken within 15 days

Interventions

Doxycycline Group

Oral doxycycline 100mg was taken within 15 days

Intervention Type: DRUG

placebo Group

Oral placebo was taken within 15 days

Intervention Type: DRUG

Other Intervention Names

Group A; Group B

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Farahmand

assistant prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

515

Identifier Type: -

Identifier Source: org_study_id