Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.
详细描述
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of Generalized Aggressive Periodontitis
- •presence of ≥20 teeth
- •presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
- •good general health
- •<35 years of age
- •agree to participate in the study and sign a written consent
排除标准
- •pregnant or lactating
- •suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
- •received antimicrobials in the previous 6 months
- •taking long-term anti-inflammatory drugs
- •received a course of periodontal treatment within the last 12 months
研究组 & 干预措施
clarithromycin group
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
干预措施: Clarithromycin (Drug)
clarithromycin group
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
干预措施: One-stage full-mouth ultrasonic debridement (FMUD) (Other)
placebo group
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
干预措施: Placebo (Drug)
placebo group
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
干预措施: One-stage full-mouth ultrasonic debridement (FMUD) (Other)
结局指标
主要结局
Clinical Attachment Level
时间窗: 6 months
Distance from bottom of pocket to the cement-enamel junction (CEJ).
次要结局
- Probing Depth(6 months)
研究者
Mauro Pedrine Santamaria
DDS,MS,PhD
Universidade Estadual Paulista Júlio de Mesquita Filho