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Clinical study to check safety and efficacy of oral care product

Evaluation of the Safety and Efficacy of an Oral Care Formulation - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086267
Enrollment
36
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Toothpaste: The product is applied on teeth once at site for the period of 24 hours Control Intervention1: Nil: NA

Sponsors

EMAMI LTD.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Indian or Asian male and female subjects 2.Healthy subjects 3.Having complain of Bad Breath. 4.Having Odour score greater than or equal to 2 5.Healthy individuals with no underlying systemic disease affecting oral health. 6.Volunteers should subjectively report bad breath 7.Non smokers, non drinkers, and tobacco free individuals.

Exclusion criteria

Exclusion criteria: 1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Having refused to give his or her assent by signing the consent form 3.Taking part in another study liable to interfere with this study 4.Having intrinsic stains and inborn defects in enamel. 5.Having a progressive asthma 6.Having crowding of teeth. 7.Having non stabilized thyroid problems 8.Having cutaneous hypersensitivity 9.Being diabetic. 10.Having Antiseptic mouthwashes or medicated oral rinses within the past 2 weeks. 11.Having a diagnosed or highly probable allergy to one or several compounds of the oral care products or food products or to latex 12.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes 13.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 14.Having changed her oral habits in the 14 days preceding the start of the study on the studied anatomic unit

Design outcomes

Primary

MeasureTime frame
Maintaining long lasting freshnessTimepoint: Baseline, Immediate after application, 12 hours after application and 24 hours after application

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

investigators@mascotspincontrol.in02243349191

Outcome results

None listed

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