Effect of Probiotic Intervention With Lactobacillus Brevis KABP052 (CECT7480) and Lactobacillus Plantarum KABP051 (CECT7481) After Surgical Removal of Mandibular Third Molars: a Randomized, Controlled, Double-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Complications derived from surgical removal of both mandibular third molars
研究概览
简要总结
Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.
详细描述
This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Probiotic and placebo tablets with identical appearance were provided in anonymous packages to the investigators, solely labelled with the volunteer's randomization number
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy male and female undergoing surgical removal of both third mandibular molars.
- •Aged between 14 and 25 years.
- •Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise
排除标准
- •Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset.
- •Subjects having used probiotics or antibiotics within 30 days prior to study enrollment.
- •Tobacco use
- •Pregnant and breastfeeding women.
- •Known allergies to ingredients in study products.
- •Not willing to refrain from using mouthwashes during the study period
研究组 & 干预措施
Probiotic
Orodispersible tablets containing AB-DENTALAC probiotic formula.
干预措施: Probiotic AB-DENTALAC (Dietary Supplement)
Probiotic
Orodispersible tablets containing AB-DENTALAC probiotic formula.
干预措施: Surgical removal of mandibular third molars at baseline (Procedure)
Probiotic
Orodispersible tablets containing AB-DENTALAC probiotic formula.
干预措施: Ibuprofen (Drug)
Control
Orodispersible tablets without probiotic strains (excipients only).
干预措施: Placebo (Other)
Control
Orodispersible tablets without probiotic strains (excipients only).
干预措施: Surgical removal of mandibular third molars at baseline (Procedure)
Control
Orodispersible tablets without probiotic strains (excipients only).
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Complications derived from surgical removal of both mandibular third molars
时间窗: 7 days
Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist
次要结局
- Post-surgical swelling, patient-rated(Daily, for 7 days)
- Post-surgical pain, patient-rated(Daily, for 7 days)
- Post-surgical eating difficulty, patient-rated(Daily, for 7 days)