The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Change of the baseline relative clinical attachment level at 6 months
研究概览
简要总结
This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).
详细描述
Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).
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, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of GAgP;
- •presence of 20 teeth;
- •presence of teeth presenting PD>5 mm with bleeding on probing (BOP) and 2 teeth 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.
排除标准
- •were pregnant or lactating;
- •were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
- •received antimicrobials in the previous 3 months;
- •were taking long-term anti-inflammatory drugs;
- •received a course of periodontal treatment within the last 6 months;
研究组 & 干预措施
FMUD + AM
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
干预措施: amoxicillin and metronidazole (Drug)
FMUD
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
干预措施: Placebos (Drug)
SRP + AM
Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.
干预措施: amoxicillin and metronidazole (Drug)
SRP
Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.
干预措施: Placebos (Drug)
结局指标
主要结局
Change of the baseline relative clinical attachment level at 6 months
时间窗: Baseline, 3 months and 6 months
distance from the bottom of the pocket to the stent margin.
次要结局
- Change of the baseline probing depth at 6 months(Baseline, 3 months and 6 months)
- Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months(Baseline, 3 months and 6 months)
- Change in the microbial composition at 6 months(Baseline, 3 months and 6 months)
研究者
Renato Casarin
Professor at Piracicaba Dental School
University of Campinas, Brazil