None listed
Conditions
Interventions
Intervention1: Liquid Toothpaste: Manufactured by: HCP WELLNESS PRIVATE LIMITED, Marketed by: R For Rabbit Baby Product Pvt. Ltd.Route of administration: Topical Application. Mode of usage: For chil
however, application by fingertip will be preferred in this age group to ensure safety and compliance.
For children aged 3 6 years, approximately 1 2 drops of the liquid toothpaste will be dispensed
Sponsors
R For Rabbit Baby Product Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Male and Female kids 2. Age: 2-6 years (both inclusive). 3. Kids having teeth at the time of enrolment. 4. Participant in good general health as determined by the Investigator on the basis of medical history. 5. Parent(s)/legally acceptable representative(s) willing to comply with study procedures and provide written informed consent as per regulatory requirements. 6. Not to use any other marketed product for oral care during the study period.
Exclusion criteria
Exclusion criteria: 1. Participant has any known allergy to test product ingredient. 2. Participant having any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congenital heart disease, Congestive heart failure, Hepatitis, Hypotensive episodes, etc. 3. Participant has participation in any similar consumer study within the past 90 days. 4. Participant is currently using any topical medications for oral care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate the safety of test product by assessing change in pH through pH strip test 2)To evaluate the safety of test product by assessing change in root caries through International Caries Detection and Assessment System (ICDAS) by Dentist trained evaluator or dentist 3)To evaluate the safety of test product by assessing change in Product Perception Questionnaire by Participant s mother s/ Caregiver feedback using a 5-point Likert scaleTimepoint: 1) baseline and Day 30 2) baseline and Day 30 3) Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed