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临床试验/NCT05738369
NCT05738369已完成不适用

The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Lesion area

研究概览

简要总结

The goal of this randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment.

详细描述

Background: Recently, the use of probiotics has emerged as a treatment for prevention of oral cavity diseases including periodontal problems, and initial caries. The objectives of this prospective randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment. Methods: Quantitative light induced fluorescence (QLF) images were taken for three randomly allocated groups (intervention group, n=23; positive control, n=23; negative control, n=24) of patients undergoing orthodontic treatment in three separate occasions (T0: before the start of study; T1: at 6 weeks later; T2: at 3 months after the commencement of the study). Subjects in the intervention group were instructed to take one probiotic lozenge containing two strains of Lactobacillus reuteri twice daily. Sugar-free lozenges were used in the positive control group and no lozenges for the negative control group. The QLF images were analyzed using a dedicated software in order to quantitatively analyze each tooth. The primary outcomes measured were the number of newly developed lesions in each group, lesion area and amount of mineral loss (ΔF). Means and standard deviations were calculated using the Statistical Package for the Social Science (SPSS version 28, Chicago, IL, USA). Split plot ANOVA (SPANOVA) test for repeated measures was used to check differences within and between the three groups regarding lesion area and ΔF. To check which group is different from the others, Tukey's test was used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The investigated supplements were provided to the participants by a research assistant. The participants in the negative control group, however, were not blinded because they did not receive any supplements

入排标准

年龄范围
17 Years 至 33 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients from both sexes
  • Having full fixed orthodontic appliances with expected remaining treatment duration of at least 6 months
  • Optimum oral hygiene
  • Maximum of 3 restored teeth
  • Absence of defective enamel formation in the form of hypocalcification or hypoplasia

排除标准

  • Patients with poor oral hygiene
  • Defective enamel
  • Extensive restorations
  • Gingival hyperplasia
  • Salivary glands diseases
  • Smoking, alcohol consumption, mouth wash use, antibiotic or probiotic intake in the last 3 months.

研究组 & 干预措施

Probiotic

Experimental

Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

干预措施: Biogaia L. reuteri Prodentis® lozenges (Dietary Supplement)

Sugar free lozenges

Placebo Comparator

Participants received Hersheyland Ice Breakers Mints sugar free lozenges

干预措施: Hersheyland Ice Breakers Mints sugar free lozenges (Dietary Supplement)

Negative control

No Intervention

Participants received no lozenges or supplements

结局指标

主要结局

Lesion area

时间窗: 3 months

Surface area of the WSL (in pixels)

ΔF%

时间窗: 3 months

Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.

Incidence of white spot lesions (WSL)

时间窗: 3 months

Number of newly developed white spot lesions

次要结局

  • ΔFMax (%)(3 months)
  • ΔR30 (%)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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