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Safety & Efficacy of HDNT-072012

An Open label, Clinical Study to Evaluate the Oral Mucosal Safety & Efficacy of HDNT-072012 in Healthy Adult Subjects

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040379
Enrollment
40
Registered
2022-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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. 2.Subjects willing to provide consent to the study 3.Subjects with moderate oral hygiene and adhering to basic habits like using standard toothbrush and toothpaste 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 clinical study 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 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.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of test product in preventing plaque build-up evaluated through plaque index, improving gum health evaluated through Gingival index by dentist, teeth whitening effect of test product as evaluated by VITA shade card Timepoint: 1.Screening and baseline visit(day1) 2.Visit 2(Day 15) 3.Visit 3(Day 45)/End of study visit

Secondary

MeasureTime frame
Evaluation of preventing mouth odour, providing of Mouth freshness, maintain clean and healthy mouth, providing Long lasting fresh breath through subjective questionnaire, safety of test product by buccal irritation score and subject reported adverse eventsTimepoint: 1.Screening and baseline visit(day1) 2.Visit 2(Day 15) 3.Visit 3(Day 45)/End of study visit

Countries

India

Contacts

Public ContactDr Soorya Narayan H

Himalaya Wellness Company

dr.swathi.b@himalayawellness.com8067547232

Outcome results

None listed

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