Evaluation of efficacy and safety of Compact Dental Water Flosser in gingival and teeth health A Prospective randomized, open label, blinded end point assessor (PROBE) clinical study.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in severity of Gingivitis
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Compact Dental Water Flosser in gingival and teeth health. The study will be carried out at 1 to 2 centers in India. As per computer generated randomization list, participants will be randomized either to Compact Dental Water Flosser Group or Control Group in 1:1 ratio. Participant will be asked to use either toothbrush with an ADA Accepted Fluoride dentifrice twice daily with additional use of the Compact Dental Water Flosser once daily or Toothbrush with an ADA Accepted Fluoride dentifrice twice daily for 30 days. The primary objective of the study will be to assess change in severity of Gingivitis. Secondary objectives of the study will be to assess change in dental plaque, change in oral health, teeth and gingival tissue, overall change by the investigator and participant and adverse events and adverse drug reactions including vitals on day 0, day 15 and day 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants without loss of interproximal clinical periodontal attachment, with papilla completely filling the interproximal space, and with at least 24 teeth 2.Qualified participants should present with Gingival Index score 2 and more than 15 percent of the interproximal sites, excluding posterior distal sites excluded.
- •3.Willing to comply with all requirements of the study including post treatment care and attending all treatment and follow up visits.
排除标准
- •1.Vulnerable population, impacting the study outcomes 2.Participants with xerostomia, orthodontic appliances, requiring antimicrobial prophylaxis
- •Known cases of diabetics, smokers.
- •known psychomotor disorders
- •Participants having used antibiotics/anti-inflammatory agents within the last 1 month
- •Known hypersensitivity high pressure dental cleaning as per the investigator
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
Change in severity of Gingivitis
时间窗: Day 0, Day 15 and Day 30
次要结局
- 1. Change in dental plaque(2. Change in oral health)
研究者
Dr Juhi Gundavda
D. Y. Patil Deemed to be University School of Dentistry