CTRI/2023/02/049984尚未招募未知
A study to evaluate the efficacy of the test product in providing long-term relief from Dental problems
nilever Industries Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
- •The subject demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
- •Satisfactory oral soft tissue examination. absence of any abnormal oral soft tissue condition noted by the Principal Investigator,
- •Be aged 18 - 65 years, of any sex and in good general health.
- •Availability for the three-month duration of the study and for all study visits.
- •Be willing and physically able to carry out all study procedures.
- •Be willing to give written informed consent, complete a medical history form and be screened by the Study Dentist.
- •Minimum of 20 uncrowned permanent natural teeth including 5 teeth (excluding third molars).
- •Plaque Index (PI) >= 2 by the Turesky Modification of the Quigley-Hein Plaque Index at baseline.
- •Have initial mean Gingivitis index >= 1.2 as determined by the use of the Loe and Silness Gingival Index at screening and baseline.
- •With normal brushing behaviour/habit, e.g. self-reported brushing more than 1 minute, twice daily (morning/evening).
- •Be willing to use only the test product for 3 months
- •COVID negative 72 hours prior to dental visit as determined by RT-PCR test.
排除标准
- •Regular (everyday) betel leaf eater (pan) and tobacco user,
- •Use of chlorhexedine mouth rinse. Hydrogen Peroxide Mouth Wash and Herbal Drinks (Fresh vegetable and Fruit drinks)
- •Medical condition and/or regular use of any medication which might affect the outcome of the study. as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs.
- •Not have had a prophylaxis in the previous month or have one scheduled prior to the end of the study.
- •Pregnant women or women who are breastfeeding. Self-reported pregnancy.
- •Subjects scheduled for medical or dental procedures for the duration of the study.
- •Full or partial dentures wearers.
- •Current orthodontic.
- •Have oral piercings
- •Smokers or those who have smoked within 3 months of screening, including e-cigarettes or those who use chewing tobacco.
- •History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- •History of rheumatic fever. heart murmur, mitral valve prolapsed or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- •Subjects have tumors of the soft or hard tissues of the oral cavity.
- •Taking dietary supplements (e.g. multivitamins; antioxidants; fish oils).
- •History of adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients. Previous know allergy to dental materials.
研究者
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