MedPath

A study to test the benefits of the Product on Dental Health

Not Applicable
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
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).

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.

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.

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
NameTimeMethod
Significant improvement the plaque and gingival conditionTimepoint: Assessment will be done at Baseline,4,12 weeks
Secondary Outcome Measures
NameTimeMethod
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
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