CTRI/2022/07/043705
Not yet recruiting
Phase 2
An Open label Multicentre Clinical Study to Evaluate the Oral Safety and Efficacy of Himalaya Botanique Whitening Complete Care Toothpaste Simply mint and Himalaya Botanique Whitening Complete Care Toothpaste Simply peppermint in Healthy Adult Subjects
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Himalaya wellness company
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects with age group 18 years to 60 years in general good health and oral health and are willing to provide consent to the study
- •2\.Subjects with moderate oral hygiene and adhering to basic habits like using standard brush paste
- •3\.Subjects with extrinsic tea, coffee, tobacco and smoking stains on the teeth
- •4\.No history of any clinically significant medical condition
- •5\.No history of any medical problems requiring hospital care
- •6\.Willing to abide by and comply with the study protocol
- •7\.Available to comply the study procedure for the entire duration of the study.
- •8\.Should not have participated in a similar investigation in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study
Exclusion Criteria
- •1\.A known history or present condition of hypersensitivity to any test product
- •2\.Pregnant and lactating subjects
- •3\.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month
- •4\.Any history of periodontal therapy by surgical interventions
- •5\.Any history of dentine hypersensitivity treatment
- •6\.Any removable appliances such as a removable partial denture or orthodontic retainer
- •7\.Having intrinsic dental stains
- •8\.Having Chronic Generalized Periodontitis
- •9\.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk
Outcomes
Primary Outcomes
Not specified
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