Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment: a Prospective, Double-blind, Randomized, Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Gingival Index (GI)
研究概览
简要总结
Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus.
Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment.
Therefore, the aim of the study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation and prevent a dysbiosis of the oral microbiome.
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
- Double (Participant, Investigator)
盲法说明
Study participants, meeting the inclusion criteria and not fulfilling the exclusion criteria, will be assigned to the study group or to the control group using a randomization plan. Randomization plan will be generated by the Center for Clincal Studies of the University Hospital of Erlangen. The lab manager will prepare storage boxes, in which exactly 168 lozenges will be stored. Half of the boxes will contain test-lozenges (study group), half or them will contain placebo-lozenges (control group). The storage boxes for the test and the placebo group will be identical and blinded. The storage boxes will be labelled with pseudonyms in accordance to the randomization plan generated by the Center for Clinical Studies. Therefore, study participants will not have knowledge of the group affiliation. The collection of the samples and the measuring of the clinical parameters will be performed by one orthodontist, who will be blinded to the randomization of the study participants.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents from age 12 to 17 with fixed appliances undergoing orthodontic treatment
- •Signed declaration of consent by the patient and the parent or legal guardian for adolescent patients
排除标准
- •Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome
- •adolescents: body mass index > + 2 standard deviations (SD) over the average value given by the World Health Organisation (weight and height will be measured)
- •Eating disorder or underweight
- •adolescents: BMI > -2 SD under the average value given by the WHO (weight and height will be measured)
- •Above-average consumption of milk products: > 3 portions/day = >1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products)
- •allergy to ingredients of the lozenges
- •intake of antibiotics or dietary supplementation (probiotics, vitamin C/D) in the last 6 months or during the study
- •regular use of antibacterial mouth wash
- •pregnancy
- •retraction of the declaration of consent by the patient and the parent or legal guardian for adolescent patients
结局指标
主要结局
Gingival Index (GI)
时间窗: Baseline to week 4 of intake
Primary endpoint is the change of the Gingival Index (GI) from baseline to week 4. The measurement of GI is described by Löe et al, which scores the gingival condition according to the defined criteria. The scores will be measured at four sites per tooth, added and divided by four to obtain the "GI for the tooth"-Index. We will use the 'GI for the tooth' described there, but only for those teeth with fixed ortodontic brackets. The 'GI for the patient' is then the mean of the GIs for the teeth. CRITERIA FOR THE GINGIVAL INDEX SYSTEM 0 = Absence of inflammation. 1. = Mild inflammation - slight cliange in color and little change in texture. 2. = Moderate inflammation - modcrate glazing, redness,oedema, hypertrophy, bleeding on pressure. 3. = Severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration.
次要结局
- Probing pocket depth (PPD) (4-point-measurement)(Baseline till 12 months after insertion of appliance)
- Oral microbiome(Baseline till 12 months after insertion of appliance)
- Modified Plaque Index (MPI)(Baseline till 12 months after insertion of appliance)
- Local cytokine expression(Baseline till 12 months after insertion of appliance)
研究者
Dr. Corinna Lesley Seidel
Orthodontist
University of Erlangen-Nürnberg