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临床试验/NCT02572531
NCT02572531Unknown不适用

Effect of Probiotic Supplements on Pain and Oral Wound Healing After Third Molar Surgery

University of Copenhagen0 个研究点目标入组 60 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Change from Baseline in Pain with VAS scale (0-10)

研究概览

简要总结

The aim of this research is to study the effect of probiotic supplements (Lactobacillus reuteri) on post-surgical complications and oral wound healing after extraction of impacted third molars.

详细描述

Healthy volunteers are consecutively randomized to the test or placebo group. After a standardized surgical procedure, conducted under local anesthesia, the participants are instructed to take three lozenges daily (one in the morning, one at lunch time and one in the evening) containing either two strains of L. reuteri (DSM 17938 and ATCC PTA 5289; >108 CFU per lozenge) or placebo for 2 weeks. The subjects are instructed to let the tablet slowly melt in the oral cavity and to fill in a personal log-book on a daily basis throughout the postoperative period. The patients are recalled to the clinic for follow-up after 1, 2 and 3 weeks for examination. The post-surgical events (pain, swelling, discomfort, feeding problems) are registered daily by the patient in a custom-made logbook. Furthermore, the type and frequency of painkillers and antibiotic prescriptions are noted in the logbook. At the follow-ups, the healing of the wounds/lesions is scored with a clinical healing index. Stimulated saliva samples are collected at baseline and after 2 weeks and kept frozen until further analysis. In addition, smear samples are collected after 1 and 2 weeks from the extraction socket for bacterial analysis. Any subjectively perceived side- or adverse effect in connection with the intervention should be reported to the surgeon. The participants are encouraged to maintain their normal tooth brushing habits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Uncompromised general health
  • Non-smoker
  • No systemic medications (except contraceptives)
  • No recent/ongoing episode of antibiotic treatment.

排除标准

  • Any pathological condition associated with the third molars detected on radiographs prior to surgery
  • Regular consumers of probiotics

结局指标

主要结局

Change from Baseline in Pain with VAS scale (0-10)

时间窗: Three weeks: Baseline and 3 follow ups

VAS scale of the patient's perception of pain (0- I don´t feel any pain, 10- unbearable pain)

Change from Baseline in Swelling with VAS scale (0-10)

时间窗: Three weeks: Baseline and 3 follow ups

VAS scale of the patient's perception of swelling (0- not swollen at all, 10- extremely swolen, can hardly swallow)

Change from Baseline in Feeding Problems with VAS scale (0-10)

时间窗: Three weeks: Baseline and 3 follow ups

VAS scale of the patient's perception of feeding problems related to the surgery (0- I eat as usual, 10- hardly eat/liquid food ingestion)

Change from Baseline in Discomfort with VAS scale (0-10)

时间窗: Three weeks: Baseline and 3 follow ups

VAS scale of the patient's perception of discomfort (0- No discomfort at all, 10- high discomfort-can not perform daily activities)

Frequency of Painkillers Intake after Surgery

时间窗: Three weeks: Baseline and 3 follow ups

Frequency expressed in number of painkillers taken per day

Frequency of Antibiotics Intake after Surgery

时间窗: Three weeks: Baseline and 3 follow ups

Frequency expressed in number of antibiotics taken per day

次要结局

  • Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)(Three weeks: 3 follow-ups)
  • Levels of salivary oxcytocin(Two weeks: Baseline and two weeks after surgery)
  • Microbial counts(Two weeks: First and Second Follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gina Castiblanco

Dr.

University of Copenhagen

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