A Clinical Study to check the Oral Safety and Efficacy of toothpaste in Healthy Adult Subjects
- Registration Number
- CTRI/2022/06/043011
- 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
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 dental carries of minimum having at least one class I/Class II caries and maximum of 4 Cavities involving only enamel and dentin not more than 4 mm depth.
3.Subjects with moderate oral hygiene and adhering to basic habits like using standard brush paste
4.No history of any clinically significant medical condition
5.No recent history (past 3 months) of overall oral/gum bleeding disorders
6.No history of any medical problems requiring hospital care.
7.Willing to abide by and comply with the study protocol.
8.Available to comply the study procedure for the entire duration of the study.
9.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.
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 device such as a removable partial denture or orthodontic retainer.
8.The presence of any large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth.
9.Having intrinsic dental stains.
10.Having abnormal frenum attachment.
11.Having moderate to severe level of calculus and/ tartar.
12.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.
13.Suffering from any form of systemic illness, oral infections, hospitalizations and pharmacological treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine in preventing plaque build-up evaluated through plaque index and improving gum health evaluated through Gingival index <br/ ><br>2.To determine the teeth whitening effect evaluated by VITA shade card. <br/ ><br>3.To determine the efficacy in fighting against tartar build up through OHI-S <br/ ><br>4.To determine the efficacy in fighting against cavities through dental examinationTimepoint: Day1, day 15, day 30 and day 45
- Secondary Outcome Measures
Name Time Method safety of the test product will be assessed by buccal irritation score and reporting of adverse events.Timepoint: Day1, day 15, day 30 and day 45