CTRI/2023/02/050139
Not yet recruiting
Phase 2
A study to evaluate the efficacy of the test product in providing long-term relief from Dental problems
nilever Industries Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nilever Industries Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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