Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in patient's perception
研究概览
简要总结
The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study.
详细描述
This randomized clinical trial aims to evaluate the efficacy of 5 different products for the cleansing of Invisalign® clear aligners among the followings:
- drinking water;
- dish soap Svelto (Unilever Italia Mkt operations S.r.l.; Roma, IT);
- Polident Antibacterial Denture Cleaner (GlaxoSmithKline; Philadelphia, Pa, USA);
- Cleaning Crystals Invisalign® (Align Technology, Inc.; San Jose, CA, USA);
- Geldis (Kalipharm S.r.l., Alba, IT).
Patients that will sign the informed consent will be enrolled for the study; parents will sign the consent for underage patients.
2 week before the beginning of the orthodontic treatment with Invisalign clear aligners, a professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed. At the baseline (T0), the first aligner will be delivered to the patient, that must wear it for 22/24 h except for meals and oral hygiene procedures. One of the 5 cleaning product will be randomly assigned to the patient and toothbrush with silicone bristles (Kalipharm S.r.l., Alba, IT) will be given the cleaning procedures. Patients will be asked to fill in a questionnaire for the subjective appreciation on the cleaning material: the questionnaire presents 19 items evaluating organoleptic and visual characteristics of the aligners and the ease of use of the cleaning method after the first use, after 1 and after 2 weeks. After 2 weeks (T1), patient will be visited again: the questionnaire will be collected, together with the aligner, and a periodontal evaluation on the Ramfjiord teeth will be performed using the following indices: Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), (Gingival Index), BEWE (Basic Erosive Wear Examination), Schiff Air Index. After that, another questionnaire and the following aligner will be given to the patient, another cleaning product will be randomly assigned and another toothbrush will be given. The procedure will be repeated for the following 2 (T2), 4 (T3), 6 (T4) and 8 weeks (T5) until all the cleaning products are tested. All the products will be masked.
JASCO V-750 spectrophotometer (Jasco Corporation, Tokyo, Japan) will be used to evaluate adsorbance for each aligner after the application of the cleaning products. A control value will be calculated using a new clean aligner. The spectrophotometer calculates reflectance values that will be converted in adsorbance values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing orthodontic treatment with Invisalign® clear aligners.
排除标准
- •Failing to follow cleaning method instructions
- •Failing to fill in the questionnaires
研究组 & 干预措施
Geldis®
干预措施: Aligners cleansing with Geldis (Other)
Water
干预措施: Aligners cleansing with water (Other)
Dish soap
干预措施: Aligners cleansing with dish soap Svelto (Other)
Polident Antibacterial Denture Cleaner®
干预措施: Aligners cleansing with Polident Antibacterial Denture Cleaner (Other)
Invisalign Cleaning Crystals®
干预措施: Aligners cleansing with Invisalign Cleaning Crystals (Other)
结局指标
主要结局
Changes in patient's perception
时间窗: Baseline (T0) and after 14 days from baseline (T1)
Through a questionnaire, a subjective evaluation is carried out as regards: * the patient's perception of the ease of use of the five products; * the difference perceived by the patient in terms of subjective changes in color, smell, taste, cleanness and tactile sensation after the first use, after a week and after 2 weeks of the cleaning method. For each of the 19 questions, a mark from 0 (worse mark) to 10 (best mark) will be provided.
Change in adsorbance (A) value
时间窗: Baseline (T0) and after 14 days from baseline (T1)
The changes in adsorbance values evaluated with a spectrophotometer.
次要结局
- Changes in Gingival Index (GI) values(Baseline (T0) and after 14 days from baseline (T1))
- Changes in Bleeding on probing (BOP)(Baseline (T0) and after 14 days from baseline (T1))
- Changes in Probing Pocket Depth (PPD) values(Baseline (T0) and after 14 days from baseline (T1))
- Change in Schiff Air Index - Dental sensitivity test(Baseline (T0) and after 14 days from baseline (T1))
- Change of the BEWE Index Basic Erosive Wear Examination(Baseline (T0) and after 14 days from baseline (T1))
- Change in plaque index (PI):(Baseline (T0) and after 14 days from baseline (T1))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia