Clinical and Microbiological Aspects of Probiotics in Non-surgical Periodontal Therapy: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction of clinical periodontal indexes
研究概览
简要总结
The goal of this randomized clinical trial is to test the effect orally administration of Probiotics based on Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14 as adjuvant in people suffering from periodontitis stage II-III. The main questions it aims to answer are:
- QUESTION 1: orally administered probiotics based on the previous strains could represent a useful tool in support of non-surgical periodontal therapy in reducing clinical periodontal indexes?
- QUESTION 2: orally administered probiotics based on the previous strains could represent a useful tool in support of non-surgical periodontal therapy in reduce the amount of periodontal pathogens in periodontal pockets?
Partecipants in the test group will take the test probiotic for 90 days in adjunction of the routinary oral hygiene procedures.
Partecipants in the positive controlled group will take the placebo for 90 days in adjunction of the routinary oral hygiene procedures.
Partecipants in the negative control group will perform only the routinary oral hygiene procedures.
Researchers will compare 3 groups to see if orally administered probiotics based on L. rhamnosus and L. plantarum may hel in the reduction of periodontal indexes and of the periodontal pathogen bacteria.
详细描述
The diagnosis of periodontitis passes through the recording of periodontal probing values on 6 sites for each periodontal element, the recording of clinical indices such as the percentage of bleeding sites and those with plaque, finally through the execution of a full-x-ray consisting of intraoral films that guarantee staging through the calculation of the loss of clinical attachment, corresponding to the loss of alveolar bone caused by the disease. The therapy of periodontitis is composed of several steps and begins with the control of the biofilm. This control is carried out with professional supragingival hygiene sessions followed by subgingival instrumentation of the periodontal pockets in order to remove the hard and soft deposits below the gingival margin, which would not otherwise be eliminated with the supragingival strategy alone. The response to mechanical therapy and the risk of relapses go hand in hand with the patient's response, his ability to maintain a good level of oral hygiene at home and to keep return appointments. In this sense, dental research has worked hard to develop additional aids to mechanical therapy to try to improve its performance. In the last decade in particular, the use of probiotics has found an increasingly wider field in periodontology, as they are based on the idea of enhancing the eubiosis ratios of the non-pathogenic flora in order to make the environment unfavorable for the proliferation of a pathogenic flora.
The present study aims to evaluate whether the quarterly oral administration of probiotics based on Lactobacillus plantarum LP14 and Lactobacillus rhamnosus LR04 can improve the response to non-surgical periodontal therapy of subgingival instrumentation in patients suffering from stage II-III periodontitis and complexity of grade A-B.
Primary objective To evaluate the adjuvant effect of probiotics based on Lactobacillus plantarum LP14 and Lactobacillus rhamnosus LR04 in non-surgical periodontal therapy.
Secondary objective Characterize the microbiological picture of patients with periodontitis with and without the aid of probiotics.
MATERIALS AND METHODS Three groups of volunteers of both sexes will be enrolled for the study without age restrictions.
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
- Triple (Participant, 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
- •Patients in the absence of other systemic pathologies reported in the medical history
- •smokers and non-smokers, non-drinkers,
- •subjects in the absence of previous or current administration of other sources of probiotics,
- •subjects capable of providing informed consent.
排除标准
- •Subjects with a history of systemic diseases (diabetes, autoimmune diseases, inflammatory bowel diseases, neurodegenerative diseases),
- •drinkers,
- •subjects who take or have taken probiotics in the last 3 months,
- •subjects unable to provide informed consent.
结局指标
主要结局
Reduction of clinical periodontal indexes
时间窗: From enrollement to the end of treatment at 3 months.
Evaluation of clinical periodontal indexes, such as: bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), total number of pathological sites in %.
次要结局
- Reduction of periodontal pathogen bacteria amount.(From enrollement to the end of treatment at 3 months.)
研究者
Prof. Marco Dolci
Full Professor
G. d'Annunzio University