Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Probing Depth
研究概览
简要总结
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.
详细描述
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 2 DM for ≥5 years
- •DM treatment with oral hypoglycemic agents or insulin supplementation and diet
- •glycated hemoglobin (HbA1c) levels from 6.5% to 11%
- •at least 15 teeth (excluding third molars and teeth indicated for extraction)
- •moderate to severe generalized chronic periodontitis (Armitage, 1999)
- •agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
排除标准
- •medical conditions that required prophylactic antimicrobial coverage
- •SRP in the previous 6 months
- •antimicrobial therapies in the previous 6 months
- •anti-inflammatory therapies in the previous 6 months
- •systemic conditions, other than DM, that could affect the progression of chronic periodontitis
- •current use of medication that could interfere with periodontal response to treatment
- •pregnancy or lactation
结局指标
主要结局
Probing Depth
时间窗: Reductions in Probing Depth was compared at baseline and 180 days
Assessed with manual probe (North Carolina, Hu-Friedy)
次要结局
- Clinical Attachment Level(Clinical Attachment Level gain was compared at baseline and 180 days)
研究者
Nídia Cristina Castro dos Santos
DDS
Universidade Estadual Paulista Júlio de Mesquita Filho