A Protocol for the Assessment of the Bacterial Loads of Essix Retainers in Patients Under Retention Therapy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in BOP - Bleeding on Probing (percentage)
研究概览
简要总结
The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Microbiological samples were taken from the retainers at the baseline, after 1 and after 2 months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test.
详细描述
The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients who wear essix retainers for contention therapy are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Periodontal evaluation and microbiological samples are conducted at the baseline, after 1 and after 2 months.
Bacterial loads are collected from essix retainers, whereas Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test are assessed from the patients' mouth.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who completed orthodontic treatment and under Essix retainers phase.
排除标准
- •Patients under orthodontic treatment with fixed appliances or clear aligners.
- •Non-orthodontic patients.
结局指标
主要结局
Change in BOP - Bleeding on Probing (percentage)
时间窗: Study begin, 1 and 2 months
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual). Percentage of sites with bleeding on probing determines the BOP%.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
时间窗: Study begin, 1 and 2 months
Scoring criteria: 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area.
Change in Schiff Air Index - Dental sensitivity test
时间窗: Study begin, 1 and 2 months
Scoring criteria: * 0: the subject did not respond to air blasting; * 1: the subject responded to air blasting; * 2: the subject responded to air blasting and requested discontinuation; * 3: the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change in PCR% - Plaque Control Record (percentage)
时间窗: Study begin, 1 and 2 months
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Change in microbiological loads of clear aligners
时间窗: Study begin, 1 and 2 months
Microbiological assessment of the following loads: * Porphyromonas gingivalis * Tannarella forsythensis * Treponema denticola * Peptostreptococcus micros * Total bacterial load
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia