A study to test the benefits of the Product on Dental Health
- Registration Number
- CTRI/2023/02/049984
- Lead Sponsor
- nilever Industries Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Significant improvement the plaque and gingival conditionTimepoint: Assessment will be done at Baseline,4,12 weeks
- Secondary Outcome Measures
Name Time Method Significant improvement in over all oral health condition like oral soft tissue, oral malodour, gum inflammation.Timepoint: assessment will be done at Baseline,4,12 weeks