The Efficacy and Safety of Tooth Bleaching Procedure Using Y10 Whitening Toothpaste and RF Current
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- At the end of the treatment (V3), compared to prior of treatment, the mean shade change will be at least two shades (Vita Bleachguide) as measured at the middle one-third area of the labial surface of the selected target teeth.
研究概览
简要总结
Study title: The Efficacy and Safety of tooth bleaching procedure using Y10 Whitening toothpaste and RF current
The Device: The Brighttonix Y10 Tooth Whitening system is indicated for use in painless non-invasive tooth whitening treatments.
Design: Single center, randomized, controlled, double blind, two-arm, prospective clinical study.
Follow up visits at 7 days (phone visit), 12 weeks and 26 weeks.
详细描述
Purpose: To assess the efficacy and the safety of tooth bleaching procedure using Y10 Whitening toothpaste and RF current (Y10 Device), versus placebo (no RF current and off- the -shelf non bleaching toothpaste) in healthy patients seeking tooth bleaching.
No. of Subjects/Sites: A total of 60 patients at Hadassah Medical Center will be randomized, 30 patients for the test arm, and 30 patients for the placebo arm.
A 40% to 60% male (or female) ratio will be maintained.
Target teeth: At least 4 teeth between teeth 13-23 (Upper front teeth) according to the international teeth numbering system.
Upper and lower teeth will be treated with the same treatment arm as described.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated Informed Consent Form.
- •Normal and controlled general health.
- •Male or female patients aged between 18-60 years old.
- •Availability for the 37 weeks duration of the study.
- •The patient has at least 4 natural teeth with no buccal restoration in the upper front area of the jaw (teeth 13-23), at least 2 of them with VITA shade >15, in accordance with VITA Bleachedguide 3D-MASTER (P/N: B361, VITA Zahnfabrik H Rauter GmbH & Co. KG, D-79713 Bad Sackingen, Germany).
- •Females of childbearing potential must be non-pregnant or non-lactating during the course of the study
排除标准
- •Underwent a teeth bleaching procedure in the last 3 years.
- •Pockets of >5 mm with BOP in the target area.
- •Heavy smokers - > 10 cigarettes per day.
- •Tetracycline staining of target teeth.
- •Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
- •Presence of dental restorations in more than 2 teeth in the target area.
- •Uncontrolled periodontitis or sever gingival inflammation
- •Scheduled or simultaneous periodontal treatment.
- •Presence of orthodontic appliances, or any removable appliances.
- •Presence of soft or hard tissue tumours of the oral cavity.
- •Presence of any of the following oral conditions: major recurrent aphthous ulcers, stomatitis, abscesses and related oral pathologies.
- •The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- •Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
- •Implanted pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- •Medical conditions of bleeding disorders, leukaemia, cirrhosis, vascular disease, sarcoidosis, active hepatitis, HIV.
研究组 & 干预措施
treatment group
the operator will administer the Y10 whitening toothpaste in to the attachable mouthpiece and place it in the subject's mouth and turn on the device RF. After treating the patients for 30 minutes the operator will turn off the device and retrieve the mouthpiece from the mouth.
干预措施: The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device (Device)
placebo group
the operator will administer an off the shelf regular toothpaste in to the attachable mouthpiece and place it in the subject's mouth. At this point the operator will switch on the device but the RF will not be activated. After 30 minutes the operator will turn off the device and retrieve the mouthpiece from the mouth.
干预措施: OTC toothpaste and an unoperated Y10 device (Other)
结局指标
主要结局
At the end of the treatment (V3), compared to prior of treatment, the mean shade change will be at least two shades (Vita Bleachguide) as measured at the middle one-third area of the labial surface of the selected target teeth.
时间窗: 26 weeks
次要结局
- Periodontal parameters at baseline, 3 and 6 months: plaque index - all at the target teeth.(up to 26 weeks)
- Compared to prior of treatment, the mean shade change at 3 and 6 months will be at least one shade (Vita Bleachguide) as measured at the middle one-third area of the labial surface of the selected target teeth.(up to 26 weeks)
- Compared to prior of treatment, the mean shade change for the lower teeth numbers 43-33 after treatment, 3 and 6 months will be at least one shade.(up to 26 weeks)
- Lesion in the gingiva of the upper and lower teeth (+/- in each of the teeth numbers 33-43, 13-23 after treatment and 3 months.(12 weeks)
- Compared to prior of treatment - teeth sensitivity to cold and touch stimulation - target teeth - VAS scale after treatment, 3 and 6 months.(up to 26 weeks)
- Periodontal parameters at baseline, 3 and 6 months: sulcular bleeding index- all at the target teeth.(up to 26 weeks)
- Periodontal parameters at baseline, 3 and 6 months: pocket depth - all at the target teeth.(up to 26 weeks)
- Compared to prior of treatment, color change evaluates with a spectrophotometer (VITA Easyshade) before and after treatment, at 3 and 6 months will be at least one shade.(up to 26 weeks)
- Patient oral questionnaire - post treatment, 7 days, 3 months, 6 months.(up to 26 weeks)
- Patient Reported Outcomes: (Scale 0-4). OHIP14-aesthetics questions for patients that received dental bleaching - (see below) - before treatment and in 3 months.(12 weeks)