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A clinical study to assess safety and effectiveness of toothpaste in healthy adult subjects

An Open label, Clinical Study to Evaluate the Oral Safety & Efficacy of Himalaya Neem and Pomegranate toothpaste in Healthy Adult Subjects

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043641
Enrollment
40
Registered
2022-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Himalaya wellness company
Lead Sponsor

Eligibility

Inclusion 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.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

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

Design outcomes

Primary

MeasureTime frame
. To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index . To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index . 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. Timepoint: Day 1, day 15 , day30, day 45

Secondary

MeasureTime frame
4. To determine the safety of test product by buccal irritation score and subject reported adverse events.Timepoint: Day 1, day 15 , day30, day 45

Countries

India

Contacts

Public ContactDr Soorya Narayan H

Himalaya wellness company

dr.swathi.b@himalayawellness.com9538969888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026