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To evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy subjects.

A clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy adult subjects with oral malodor and bleeding gums. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071277
Enrollment
36
Registered
2024-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: K055- Other periodontal diseases

Interventions

Intervention1: Patanjali Dantkanti Fresh Active Gel Toothpaste: Apply approx. 1 gm of toothpaste on the affected area twice a day with a cleaned fingertip and massage gently for a minute followed by 1

Sponsors

Patanjali Ayurved Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with gingivitis and having extrinsic dental stains. 2. Subjects having T-VSC reading (total volatile sulphur compounds) of =140 ppb (parts per billion). 3. Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visit. 4. Subjects should be willing to not consume anything except water after a meal of the previous night.

Exclusion criteria

Exclusion criteria: 1. Subject with orthodontic bands. 2. Subject with partial removable dentures. 3. Subject having tumor (s) of the soft or hard tissues of the oral cavity. 4. Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. Subject with five or more carious lesions requiring immediate restorative treatment.

Design outcomes

Primary

MeasureTime frame
To assess the effect of the test product on the reduction in T-VSC reading (total volatile sulfur compounds) using a HalimeterTimepoint: Comparison of baseline i.e. Day 01 (before brushing) with 0 hour (+15 mins) after brushing and with 4 hours (+15 mins), 8 hours (+15 mins), and 12 hours (+15 mins) after brushing but before having meals at each time point on Day 01.

Secondary

MeasureTime frame
Subjective evaluation questionnaireTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).;Subjects’ perception questionnairesTimepoint: 0 mins (plus 5 mins), 30 mins (plus 5 mins) and 60 mins (plus 5 mins)on Day 01 and Day 30 (plus 2 days).;To assess the effect of the test product on Germ Protection by microbial analysis for S. mutansTimepoint: Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins), and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01.;To assess the effect of the test product on the reduction in gingivitis using Gingival indexTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).

Countries

India

Contacts

Public ContactDr Parth Joshi

Cliantha Research

ssethi@cliantha.com9825784942

Outcome results

None listed

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