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Clinical Study of BabyOrgano toothpaste.

A single-arm clinical study assessing the efficacy and safety of BabyOrgano toothpaste to promote dental health in children. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071262
Enrollment
30
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

None listed

Interventions

Intervention1: BabyOrgano toothpaste A: Use a pea-sized amount of toothpaste, gently brush teeth twice a day, in the morning and at night after meals then rinse with clean water for 15 days. Intervent

Sponsors

Natureovedic Consumers Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female participants of age between 1–7 years (both inclusive);2. Parents/guardians of participants providing voluntary, written informed consent to participate in the study;3. Ability of parents/guardians of participants to understand and comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity to one of the ingredients of the toothpastes to be tested 2.Systemic disorders interfering with salivary function or flow 3.Regular medication intake interfering with salivary function or flow 4.Need for antibiotic prophylaxis during dental treatments 5.Participation in any other clinical study within the past 3 months or ongoing 6.Lack of intellectual or physical ability to follow the instructions of the study protocol 7.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.

Design outcomes

Primary

MeasureTime frame
1.Assessment of changes Plaque score index. 2.Assessment of changes in pain sensation in response to tactile stimulus (Wong-Baker FACES pain rating scale).Timepoint: Baseline to end of the study.

Secondary

MeasureTime frame
1.Assessment of changes in calculus index, Changes in dentist-reported visual teeth whiteness assessment score. 2.Assessment of changes in caries status using The International Caries Detection and Assessment System (ICDAS) at baseline and end of the study. Timepoint: 1.Baseline to end of the study. 2.Baseline and end of the study.

Countries

India

Contacts

Public ContactDr Urvi Ashani

Natureovedic Consumers Private Limited

urvi@babyorgano.com9409208578

Outcome results

None listed

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