A Clinical Study to check the Oral Safety & Efficacy of Himalaya Botanique Complete care toothpaste in Healthy Adult Subjects

Phase 2

Registration Number: CTRI/2022/07/043756

Lead Sponsor: Himalaya wellness company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.No history of any clinically significant medical condition

4.No history of any medical problems requiring hospital care

5.Willing to abide by and comply with the study protocol

6.Available to comply the study procedure for the entire duration of the study.

7.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 hyper sensitivity to any test product

2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette

3. Pregnant and lactating subjects

4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month

5.Any history of periodontal therapy by surgical interventions

6.Any history of dentine hypersensitivity treatment

7.Any removable appliances such as a removable partial denture or orthodontic retainer

8.Having intrinsic dental stains

9.Having Chronic Generalized Periodontitis

10.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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index <br/ ><br>. To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index <br/ ><br>. To determine efficacy in Preventing mouth odour, providing of Mouth freshness upto X hours, fresh breath throughout the day, X hours fresh breath, maintain clean and healthy mouth evaluated through subjective self-administered questionnaire <br/ ><br>Timepoint: day1, day 15, day 30 and day 45

Secondary Outcome Measures