Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Decrease of periodontal pockets ≥ 4mm
研究概览
简要总结
The aim of the study was to compare the clinical effects of systemic use of doxycycline to amoxicillin plus metronidazole as adjunctive treatment in nonsurgical debridement of aggressive periodontitis (AgP). Twenty four patients with aggressive periodontitis were enrolled in this clinical study. They all received oral hygiene instruction and full-mouth nonsurgical debridement using manual instruments. The test group received as adjunctive antibiotic treatment 200 mg of doxycycline the first day followed by 100 mg per day during 14 days. The control group received 500 of amoxicillin and 250 of metronidazole, three times a day for 7 days.
详细描述
This comparative clinical study was conducted in the department of Periodontology, Center for Dental Consultation and Treatment (CDCT), Rabat, Morocco.
Prior to participation, the purpose of the investigation was fully explained to all participants and written informed consent was obtained from all patients. The study protocol was approved by the biomedical ethical committee of University Mohammed V in Rabat, Morocco, and conducted according to the principles outlined in the Declaration of Helsinki on experimentation involving human subjects.
Patients : Twenty four subjects diagnosed with localized (LAgP) or generalized aggressive periodontitis (GAgP) (8 patients with LAgP and 16 with GAgP) were enrolled in the study. Patients were aged between 16 and 26 years and were from both genders (22 female and 2 male).The diagnosis was based on the classification of the American Academy of Periodontology (AAP).
Clinical variables were pocket depth, plaque index, gingival index
At the end of the debridement sessions, patients were assigned doxycycline or the amoxicillin plus metronidazole regardless the type of AgP. So that, experimental group of patients were administered 200 mg of doxycycline the first day followed by 100 mg per day for 14 days, and the control group were administered 250 mg of metronidazole and 500 mg of amoxicillin, three times a day for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 36 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects in good general health,
- •presence of at least 20 teeth,
- •no periodontal treatment performed during the previous 12 months,
- •absence of antibiotic intake during six months before the study,
- •and no known allergies to antibiotics used in the study
排除标准
- •pregnancy,
- •lactation,
- •and smoking.
研究组 & 干预措施
doxycycline group
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
干预措施: Doxycycline (Drug)
amoxicillin plus metronidazole group
Drug Dispamox 500 mg, 3 times a day for 7 days Flagyl 250 mg, 3 times a day for 7 days
干预措施: amoxicillin plus metronidazole (Drug)
结局指标
主要结局
Decrease of periodontal pockets ≥ 4mm
时间窗: 3 months
• Probing pockets depths were assessed to the nearest millimeter using a standard periodontal probe, when recruiting patient at baseline and the re-evaluation 3 months after nonsurgical mechanical debridement.
次要结局
- Plaque index decrease(3 months)
- Gingival index decrease(3 months)
研究者
BENRACHADI Latifa
Professor
Mohammed V Souissi University