Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing Limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage II, grade A, B and C, generalized periodontitis.
详细描述
The main purpose of this study is to assess the effect on disease progression of the probiotic Limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage II, grade A, B and C, generalized periodontitis: evaluated by Bleeding on Probing (BoP) - Lindhe, 1972. The secondary purpose is to evaluate the effect of this probiotic on the values of Plaque Index (PI) - Silness & Löe, 1964; Gingival Index (GI) - Löe & Silness, 1963; Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) - Ramfjord, 1959, when compared to a negative control product.
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
- Quadruple (Participant, Care Provider, 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 over 18 years old, who intend to voluntarily participate in the study and:
- •Have a definitive diagnosis of stage II, grade A, B or C, generalized periodontitis (2018, World Workshop);
- •Have at least 3 natural teeth maintained per quadrant.
排除标准
- •• Patients unable to understand the instructions necessary to participate in the study or unable to give informed consent;
- •Patients who have received any type of periodontal treatment 2 months prior to the start of study participation;
- •Pregnant or breastfeeding patients;
- •Patients with associated systemic pathology, such as diabetes, HIV, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants;
- •Patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-A and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride);
- •Patients undergoing anticoagulant therapy;
- •Patients allergic to both lidocaine, articaine and mepivacaine;
- •Patients who require antibiotic prophylaxis for bacterial endocarditis;
- •Patients who have had antibiotic therapy within 2 months of study participation;
- •Patients using chlorhexidine, or other mouthwashes or elixirs;
- •Patients undergoing orthodontic treatment.
结局指标
主要结局
Change From Baseline in Bleeding on Probing (BoP) - Lindhe, 1972
时间窗: 0, 21, 90, 180 days
Bleeding on probing (in percentage) will be assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively.
次要结局
- Change From Baseline in Gingival Index (GI) - Löe e Silness, 1963(0, 21, 90, 180 days)
- Change From Baseline in Probing Depth (PD)(0, 21, 90, 180 days)
- Change From Baseline in Plaque Index (PI) - Silness & Löe, 1964(0, 21, 90, 180 days)
- Change From Baseline in Clinical Attachment Level (CAL) - Ramfjord, 1959(0, 21, 90, 180 days)
研究者
André Marques
Principal investigator - student of the Specialization in Periodontology and Oral Implants
Universidade do Porto