Efficacy of Probiotics in Improving Post-surgical Healing for Impacted Tooth Extractions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Surgical wound healing
研究概览
简要总结
A randomized, double-blind, placebo-controlled clinical trial will be performed to assess the efficacy of a probiotic containing Lactobacillus reuteri in improving post-surgical wound healing after impacted tooth extractions.
The Primary aim is to evaluate the efficacy of L. reuteri in improving post-extractive healing.
The Secondary aim is to evaluate the efficacy of L. reuteri in association with an antibiotic therapy (amoxicillin) in reducing the incidence and severity of antibiotic-associated gastro-intestinal symptoms.
详细描述
Probiotics are defined by the World Health Organization as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." Human microbiome is a complex system that contributes to maintaining a good health status in humans. Broad-spectrum antibiotic therapies act against pathogen bacteria but also affect the intestinal microbiome, leading to different side effects such as abdominal pain, gastric pain, nausea, vomit and diarrhea.
The use of probiotics has been advocated as a possible means in reducing intensity and incidence of the symptoms related to antibiotic therapies. Some probiotics like Lactobacillus reuteri (L. reuteri) showed good anti-inflammatory properties and also antimicrobic action, assuming a possible role in wound healing processes.
Few studies have been conducted on the use of L. reuteri in dentistry. Twetman et al. (2018) conducted a trial to assess the efficacy of L. reuteri in improving post-surgical healing in the oral cavity after a punch biopsy, showing promising results. The authors concluded that larger trials may be useful to better clarify the role of probiotics in oral wounds healing. The only data regarding the possible role of L. reuteri in post- extractive healing comes from a pilot study (Walivara at al. 2019) that showed a reduction of the perceived swelling and of the number of disturbed-sleep nights in patients who underwent impacted-tooth extraction and assumed L. reuteri. Authors concluded that larger trials with closer follow-up visits are required to fully understand the clinical correlation.
The primary aim of the present research is to evaluate the efficacy of a probiotic containing L. reuteri in improving post-surgical healing following impacted tooth extractions and the secondary aim is to investigate its possible role in preventing or reducing gastro-intestinal side effects related to post-operative antibiotic therapy.A Randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of L. reuteri in improving post-extractive healing.
All patients who need impacted tooth extractions at University Hospital of Pisa (Operative Unit of Odontostomatology and Oral Surgery) will be considered eligible for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •need for impacted tooth extractions
- •over age 18
- •ability to understand and to sign an informed consent form
排除标准
- •allergy to penicillin
- •contraindications to oral surgery
- •treatment with immunosuppressive agents or immunocompromised
- •treatment with amino-bisphosphonate and anti-angiogenetic medications
- •irradiation to head and neck area
- •uncontrolled diabetes
- •renal failure
- •drug and alcohol addiction
- •psychiatric disorders
结局指标
主要结局
Surgical wound healing
时间窗: 14 days after the surgery
Clinical assessment of the characteristics of the surgical wound
次要结局
- Alveolar osteitis(14 days after the surgery)
- Fever(14 days after the surgery)
- Difficulty in speaking(14 days after the surgery)
- Presence of pain(14 days after the surgery)
- Abscess(14 days after the surgery)
- Edema(14 days after the surgery)
- Trismus(14 days after the surgery)
- bleeding on palpation(14 days after the surgery)
- Painkillers(7 days after the surgery)
- Difficulty in chewing(14 days after the surgery)
- Abdominal distension(14 days after the surgery)
- Nausea(14 days after the surgery)
- Difficulty in performing oral hygiene(14 days after the surgery)
- Daily routine alterations(14 days after the surgery)
- Number of disturbed-sleep nights following the extraction(14 days after the surgery)
- Vomit(14 days after the surgery)
- Gastric acidity(14 days after the surgery)
- Loss of appetite(14 days after the surgery)
- Sensation of swelling(14 days after the surgery)
- Abdominal pain(14 days after the surgery)
- Alvus variation(14 days after the surgery)
- Acid reflux(14 days after the surgery)
- Gastric pain(14 days after the surgery)
研究者
Antonio Barone
Professor
University of Pisa