Kaklamanos Eleftherios G, Nassar Rania, Kalfas Sotirios, Al Halabi Manal, Kowash Mawlood, Hannawi Haifa, Hussein Iyad, Salami Anas, Hassan Ammar, Senok Abiola C
Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.
College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.
BMJ Open. 2019 Sep 8;9(9):e030638. doi: 10.1136/bmjopen-2019-030638.
There is limited data on the beneficial effects of probiotics on the gingival health of patients undergoing treatment with fixed orthodontic appliances. This study aims to compare the effect of probiotic tablets combined with regular oral hygiene versus regular oral hygiene alone on gingival status in these patients. The effect of probiotic intake on plaque formation and salivary microbiome composition will be also assessed.
This is a 3 month single-centre, single blind (clinical and laboratory examiners), parallel group randomised controlled two arm superiority trial. Fifty paediatric patients attending the Postgraduate Orthodontic Clinic at the Hamdan Bin Mohammed College of Dental Medicine (HBMCDM), Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, United Arab Emirates, who meet the eligibility criteria will be recruited. Block randomisation with 1:1 allocation and concealment of allocation will be carried out. The treatment group will receive probiotic tablets containing M18 and together with regular oral hygiene versus the control group on regular oral hygiene alone. Clinical examination and collection of saliva for microbiome assay will be carried out at baseline and end of study. Self-reporting by patients will be used to document acceptability and adverse effects. Statistically significant decrease in gingival bleeding on probing in the treatment group will be classified as primary outcome of treatment success. Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.
Ethical approval for the study has been granted by the HBMCDM, MBRU, Institutional Review Board (Reference #: MBRU-IRB-2018-015). Study findings will be disseminated via publication in peer-reviewed journal.
ISRCTN95085398.
关于益生菌对接受固定正畸矫治器治疗患者牙龈健康有益影响的数据有限。本研究旨在比较益生菌片联合常规口腔卫生措施与单纯常规口腔卫生措施对这些患者牙龈状况的影响。还将评估摄入益生菌对牙菌斑形成和唾液微生物群组成的影响。
这是一项为期3个月的单中心、单盲（临床和实验室检查人员）、平行组随机对照双臂优效性试验。将招募50名符合入选标准的儿科患者，他们在阿拉伯联合酋长国迪拜穆罕默德·本·拉希德医学与健康科学大学（MBRU）哈姆丹·本·穆罕默德牙科学院（HBMCDM）的研究生正畸诊所就诊。将进行1:1分配的区组随机化和分配隐藏。治疗组将接受含有M18的益生菌片并结合常规口腔卫生措施，而对照组仅采取常规口腔卫生措施。在基线和研究结束时进行临床检查并收集唾液进行微生物群分析。将采用患者自我报告来记录可接受性和不良反应。治疗组探诊时牙龈出血有统计学意义的减少将被分类为治疗成功的主要结局。菌斑指数、牙龈指数有统计学意义的降低以及口腔微生物群组成向有益菌的转变是表明摄入益生菌有效性的次要结局。
该研究已获得HBMCDM、MBRU机构审查委员会的伦理批准（参考编号：MBRU-IRB-2018-015）。研究结果将通过在同行评审期刊上发表进行传播。
ISRCTN95085398。
