Antibiotic Therapy in Erupted Tooth Extractions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 主要终点
- Rate of post-operative alveolar osteitis after tooth extractions
研究概览
简要总结
Evaluation of the efficacy of amox+clav and of a probiotic after tooth extraction. the aim is to evaluate efficacy of antibiotic therapy after tooth extractions in preventing infections as compared to no therapy, and efficacy of probiotics in preventing gastro-intestinal adverse effects during the antibiotic treatment. The number of patients to be included is 150. The study products are: Amoxicillin + Clavulanic Acid and Bifidobacterium Longum and Lactoferrin.
详细描述
The main objective of this trial is to evaluate the efficacy of the antibiotic after tooth extraction in preventing infections and to evaluate the effect of probiotic in reducing the possible antibiotic side effects. In order to analyze the effect of the antibiotic in terms of patient's general discomfort, a tailored form was prepared (Appendix A). The local signs and symptoms to evaluate are swelling, pain (assessed by the Visual Analogic Scale), presence of abscess, fever, post-extraction dental alveolitis (dry socket) and presence of trismus assessed as maximal mouth opening variation (mm). In addition adverse post-extraction events will be evaluated as follows: chewing impairments (assessed by the Visual Analogic Scale), speaking impairments (assessed by the Visual Analogic Scale), daily oral hygiene maneuvers impairments (assessed by the Visual Analogic Scale) and daily activities alterations (days-off from job/study). Moreover, the patients will be provided with a painkiller's prescription and they are required to take note of the painkillers needed during the first 7 days, i.e. until the first time point recall. The prescribed painkillers will be Ibuprofen 600 mg or naproxen sodium 500mg for those patients who reported allergy to ibuprofen. Finally, it will be a researcher duty to ask the patients if they needed to assume painkillers beyond the 7th day. Since the post-surgical sequelae depend also on the difficulty of extraction, the Appendix A provides a table in which the surgeon can take note of the type of extraction.
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
- 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
- •Patients who needed tooth extractions
- •Patients older than 18 years
- •Patients able to understand and to sign a consent form
排除标准
- •General contraindications to oral surgery
- •Third molar or impacted tooth extractions
- •Patients treated or under treatment with immunosuppressive agents or patients immunocompromised
- •Patients treated or under therapy with amino-bisphosphonate and anti-angiogenetic intravenous medications
- •Patients who received head and neck irradiation treatments
- •Patients who were diagnosed with uncontrolled diabetes
- •Patients suffering from renal failure
- •Pregnancy and breastfeeding patients
- •Patients diagnosed with drug and alcohol addiction
- •Patients who suffer from psychiatric disorders
- •Patients diagnosed with allergy to penicillin and probiotic
研究组 & 干预措施
Tooth extraction and antibiotic treatment
Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days
干预措施: Amoxicillin Clavulanate (Drug)
tooth extraction and antibiotic treatment + dietary supplement
Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days
干预措施: Amoxicillin Clavulanate (Drug)
tooth extraction and antibiotic treatment + dietary supplement
Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days
干预措施: Bifidobacterium longum and Lactoferrin (Dietary Supplement)
结局指标
主要结局
Rate of post-operative alveolar osteitis after tooth extractions
时间窗: 21 days
alveolar osteitis, presence or absence of exposed bone
Rate of post-operative infection after tooth extractions
时间窗: 21 days
infection, presence or absence of pus drainage
次要结局
- gastrointestinal symptoms(21 days)
研究者
Antonio Barone
Associate Professor ( DDS, PhD, MSc)
University of Pisa
