Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The Primary Outcome Variable Was Probing Depth.
研究概览
简要总结
The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin plus metronidazole combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in 6-month follow-up.
A total of 40 systemically healthy patients with GAgP will evaluate in this randomized clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.
详细描述
The American Academy of Periodontology and the European Federation of Periodontology were reported that patients with GAgP may have benefit from adjunctive administration of antibiotics. Antibiotics are used as an adjunct to nonsurgical treatment either locally or systemically. Systemic antimicrobial agents as adjunct to nonsurgical treatment provide additional benefits over mechanical therapy alone in terms of probing depth reduction and periodontal attachment gain.
Amoxicillin is a moderate spectrum, bacteriolytic β-lactam antibiotic, and metronidazole which is active against anaerobic bacteria is a nitroimidazole. scaling and root planing combination with metronidazole plus amoxicillin therapy was found to be more effective in suppressing P. gingivalis and eradication of A. actinomycetemcomitans and preventing re-colonization of A. actinomycetemcomitans because of the synergistic effect of this combination and their wide spectrum of activity. It was found to be superior to azithromycin, doxycycline, and metronidazole in the treatment of GAgP.
Quinolones were introduced for use in urinary tract infections in the 1970s. Moxiflocaxin is a fourth generation fluoroquinolone antibiotic exhibits good tissue penetration and high oral bioavailability and has improved activity against Gram- positive, aerobic and anaerobes. Moxifloxacin is used in the systemic treatment of respiratory infections, acute sinusitis, odontogenic abscesses, osteomyelitis of the mandible and locally in the treatment of ophthalmic infections.
Moxiflocaxin has good activity against putative periodontal pathogens, including Porphyromonas gingivalis, Tanneralla forsythia, Prevotella spp, Fusobacterium nucleatum, Actinomyces spp, Campylobacter rectus, Peptostreptococcus spp. and Aggregatibacter actinomycetemcomitans, located within biofilm or intracellulary. It was shown that A.a. strains were highly susceptible to fluoro-quinolones ciprofloxacin and moxifloxacin. Some of the adjunctive antibiotics are secreted in saliva in insufficient concentrations to inhibit A.a. Moxifloxacin seems to be secreted in saliva at higher levels than in plasma and may also concentrate at the site of infection since it penetrates polymorphonuclear granulocytes and epithelial cells. Moxifloxacin was found to be superior to clindamycin, metronidazole or doxycycline.
Systemic administration of moxifloxacin as an adjunct to scaling and root planing was found to be more effective compared to scaling and root planing alone or scaling and root planing in conjunction with doxycycline in the treatment of severe chronic periodontitis. To best our knowledge, there is no study that evaluates the effect of moxifloxacin adjunct to scaling and root planing in the treatment of GAgP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.
- •Patients were included if they were between 18 and 35 years of age and otherwise healthy.
排除标准
- •if the patients had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases)
- •history of hepatitis or HIV infection,
- •immunosuppressive chemotherapy
- •current pregnancy, planning a pregnancy or lactation
- •requirement for antibiotic prophylaxis
- •oral diseases other than GAgP, ongoing orthodontic therapy
- •a history of antibiotic therapy or periodontal treatment within the preceding six months.
- •Subjects were excluded if they had known allergies to quinolones or penicillin or metronidazole
- •Not willing to participate to the study.
- •Not accept to sign written informed consent
研究组 & 干预措施
amoxicillin+metronidazole
amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.
干预措施: Amoxicillin (Drug)
amoxicillin+metronidazole
amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.
干预措施: Metronidazole (Drug)
moxifloxacin
The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
The Primary Outcome Variable Was Probing Depth.
时间窗: 6-months
We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.
次要结局
- The Attachment Loss Were Considered as a Secondary Measure.(6-months)
研究者
Esra Guzeldemir-Akcakanat
Associate Professor
Kocaeli University
