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临床试验/NCT04082598
NCT04082598已完成4 期

Antibiotic Therapy in Erupted Tooth Extractions

Antonio Barone0 个研究点目标入组 165 人开始时间: 2016年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

发起方
Antonio Barone
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Antonio Barone

Associate Professor ( DDS, PhD, MSc)

University of Pisa

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