The Effects of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus: A Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Periodontal pocket depth
研究概览
简要总结
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.
详细描述
Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive enzymes in periodontal disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnancy or lactation
- •History of allergy to drugs used in the study
- •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
- •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.
研究组 & 干预措施
oral doxycycline
Oral capsules of doxycycline 100 mg were used
干预措施: Doxycycline Group (Drug)
oral placebo capsule
oral placebo capsule were used
干预措施: placebo Group (Drug)
结局指标
主要结局
Periodontal pocket depth
时间窗: 15 days
Periodontal Probes Measuring (millimeters)
次要结局
- glycated hemoglobin (HbA1c)(3 months)
研究者
Amirhossein Farahmand
assistant prof
Islamic Azad University, Tehran