CTRI/2022/02/040692已完成不适用
A study to evaluate the efficacy of the test product in providing short term and long-term relief from dental Problems
Unilever Industries Pvt Ltd1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年1月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Significant improvement in tooth and gum health
研究概览
简要总结
Study will be conducted to assess the efficacy of test product in improving overall oral/dental health. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post wash out period, test product will be dispensed to subjects and post baseline assessment subjects will be instructed to use the product for 2 month period. Evaluation assessments will be done at different times points over a period of 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects between 18 to 65 years of age.
- •2.Subjects having atleast 16 natural, permanent teeth and one or two teeth with dental problems as per oral examination.
- •3.Subjects willing to report to site on visit 2 without a mouth wash/brushing.
- •Last brushing and mouth wash should be on the previous night i.e., atleast 12 hours prior to baseline assessment.
- •4.Subjects willing to maintain atleast 1 hour difference between last food/drink and the assessments.
- •5.Subjects willing to come for follow up visits at the specified time.
- •6.Subjects ready to follow instructions during the study period.
- •7.Subjects willing to give a voluntary written informed consent for activities in the study and agree to come for regular study visits 8.Subjects willing to abide and comply with the study protocol 9.Subjects who are willing not to participate in any other oral/dental study during participation in the current study.
- •10.Subjects agreeing to use only the given test product/washout product and refrain from the use of any non-study oral hygiene products.
排除标准
- •1.Subjects using anti-inflammatory, antibiotic, antimicrobial, analgesic medications or psychotropic drug.
- •2.Any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the baseline visit 3.Subjects who have undergone dental prophylaxis within 2 weeks prior to baseline visit 4.Any history of periodontal therapy, orthodontic treatment or teeth restored in the preceding three months by surgical interventions.
- •5.Any removable device such as a removable partial denture or orthodontic retainer.
- •6.The presence of any fixed appliance, large or defective restorations, cracked enamel, 7.History of smoking or use of smokeless tobacco products.
- •8.Subjects having abnormal frenum attachment.
- •9.Subjects who are pregnant, lactating or nursing.
- •10.Subjects having severe level of calculus and/ tartar.
- •11.Subjects having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GRED or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity 12.Subjects with history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn’s disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain food or nutrients.
- •13.Subjects with any diseases or conditions that might interfere with the safe participation in the study.
- •14.Subjects unable to undergo study procedures.
- •15.Subjects with severe xerostomia 16.Subjects having active caries within 12 months.
- •17.Subjects having high risk for caries development (rampant caries, multiple dental restorations, crown with compromised margins) per examiners discretion.
- •18.The subject is an employee of Unilever or the site conducting the study.
结局指标
主要结局
Significant improvement in tooth and gum health
时间窗: Day 1, week 2, week 4 and week 8
次要结局
- Significant improvement in overall oral health -plaque and whole mouth protection.(Day 1, week 2, week 4 and week 8)
研究者
研究点 (1)
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