Periodontal Tedavinin Helikobakter Pilori Eradikasyon ve Rekürrensine Katkısının İncelenmesi
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- eradication rate of gastric H. pylori infection
研究概览
简要总结
The efficacy of conventional systemic antibiotic therapy for eradication of gastric H. pylori has been seriously challenged by antibiotic resistance. Identification of alternative therapeutic strategies might help to overcome the limitation. The investigators' aim was to examine the effect of adjunct periodontal therapy, on gastric H. pylori eradication rate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tested positive for H. pylori both in gastric biopsy specimens and dental plaque samples
排除标准
- •The patients who had treatment with following medications within 6 months before the clinical protocol:
- •had antibiotics
- •had Proton pump inhibitor (PPI),
- •had H2 blockers, and
- •took bismuth derivatives
- •had previous eradication therapy, or
- •had previous periodontal therapy
- •Edentulous patient
- •Diabetic patients
- •pregnant patients
研究组 & 干预措施
Triple therapy
Conventional triple antibiotic treatment would be applied to all patients (consisted of a 10-day course of Lansoprazole (a proton pump inhibitor) combined with amoxicillin ( 2 × 1 g daily) and clarithromycin (2 × 500 mg daily).
干预措施: Triple therapy (Drug)
Combined treatment
Periodontal treatment would be administered in addition to triple therapy consisted of a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).
Periodontal treatment consisted of supra and sub gingival scaling and root planing, oral hygiene instruction
干预措施: Triple therapy (Drug)
Combined treatment
Periodontal treatment would be administered in addition to triple therapy consisted of a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).
Periodontal treatment consisted of supra and sub gingival scaling and root planing, oral hygiene instruction
干预措施: professional periodontal treatment (Procedure)
结局指标
主要结局
eradication rate of gastric H. pylori infection
时间窗: 3 months
The follow-up was done by a 14C-urea breath test at least 12 weeks after completion of treatment . A 14C urea breath test analyzer (HUBT-20; Headway, Guangdong, China) was used to diagnose H. pylori infection
次要结局
- periodontal parameters (Probing depth)(3 months)
- Bleeding on Probing(3 months)
- oral H. pylori eradication(3 months)
- Plaque index(3 months)
- Gingival Index(3 months)
- Clinical Attachment level(3 months)
- OHI (Oral Hygiene Index)(3 months)
研究者
Ayla Öztürk
Associate Professor
Ondokuz Mayıs University