Metronidazole and Amoxicillin as Adjuncts to Scaling and Root Planing for the Treatment of Type 2 Diabetic Subjects With Periodontitis: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Changes in number of sites with probing depth (PD) ≥5 mm post-treatment
研究概览
简要总结
Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •≥ 35 years of age
- •Diagnosis of type 2 DM for ≥ 5 years
- •DM treatment with diet and insulin supplementation or oral hypoglycemic agents
- •Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11%
- •At least 15 teeth
- •More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm
- •Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline.
排除标准
- •Pregnancy
- •Lactation
- •Current smoking
- •Smoking within the past 5 years
- •Scaling and root planing (SRP) in the previous 12 months
- •Antimicrobial therapies during the previous 6 months
- •Medical conditions requiring prophylactic antibiotic coverage
- •Continuous use of mouthrinses containing antimicrobials in the preceding 3 months
- •Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis)
- •Long-term administration of anti-inflammatory
- •Long-term administration of immunosuppressive medications
- •Allergy to metronidazole and/or amoxicillin
- •Presence of periapical pathology
- •Use of orthodontic appliances
- •Presence of extensive prosthetic rehabilitation
- •Major complications of DM (i.e. cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy)
研究组 & 干预措施
SRP+MTZ+AMX
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
干预措施: SRP (Procedure)
SRP+MTZ+AMX
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
干预措施: MTZ+AMX (Drug)
SRP+placebo
Scaling and root planing + placebo
干预措施: SRP (Procedure)
SRP+placebo
Scaling and root planing + placebo
干预措施: Placebo (Other)
结局指标
主要结局
Changes in number of sites with probing depth (PD) ≥5 mm post-treatment
时间窗: From baseline to 12 months
次要结局
- Changes in number of sites with PD ≥5mm(From baseline to 12 months and from baseline to 24 months)
- Full-mouth percentages of sites with marginal bleeding(Baseline, 3, 6, 12 and 24 months)
- Full-mouth percentages of sites with bleeding on probing(Baseline, 3, 6, 12 and 24 months)
- PD and clinical attachment level (CAL) changes at initially moderate sites(From baseline to 12 months and from baseline to 24 months)
- PD and CAL changes at initially deep sites(From baseline to 12 months and from baseline to 24 months)
- Full-mouth PD and CAL(Baseline, 3, 6, 12 and 24 months)
- Full-mouth percentages of sites with plaque(Baseline, 3, 6, 12 and 24 months)
- Full-mouth percentages of sites with suppuration(Baseline, 3, 6, 12 and 24 months)
- Full-mouth percentages of sites with PD ≥5mm(Baseline, 3, 6,12 and 24 months)
- Serum levels of glycated hemoglobin (HbA1c)(Baseline, 3, 6, 12 and 24 months)
- Serum levels of fasting plasma glucose FPG(Baseline, 3, 6, 12 and 24 months)
- Levels of periodontal pathogenic bacterial species(Baseline, 3, 6, 12 and 24 months)
- Occurrence of adverse events(14 days)
研究者
Poliana Mendes Duarte
PhD
University of Guarulhos