CTRI/2022/02/040692已完成未知
A study to evaluate the efficacy of the test product in providing short term and long-term relief from dental Problems
nilever Industries Pvt Ltd0 个研究点目标入组 193 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 193
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 Crohnâ??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.
研究者
相似试验
尚未招募
2 期
A study to test the benefits of the Ayurvedic Proprietary Medicine Product on Dental HealthCTRI/2023/02/050139nilever Industries Pvt Ltd
尚未招募
不适用
A study to test the benefits of the Product on Dental HealthCTRI/2023/02/049984nilever Industries Pvt Ltd
已完成
2 期
Study for hair growth and hair fallCTRI/2022/09/045239Monkey Creations Inc MCI54
已完成
1 期
A study to evaluate the test product in anti-ageing benefits.CTRI/2020/03/023845Impres Health Pvt Ltd37
已完成
1 期
A study to evaluate the efficacy of test product in anti-ageing benefitsCTRI/2020/03/023782Diabliss Consumer Products Pvt Ltd39