A study to test the benefits of the Product on dental problems
- Registration Number
- CTRI/2022/02/040692
- Lead Sponsor
- nilever Industries Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 193
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method