Clinical Study of BabyOrgano toothpaste.

Phase 2

Registration Number: CTRI/2024/07/071262

Lead Sponsor: atureovedic Consumers Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assessment of changes Plaque score index. <br/ ><br>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 Outcome Measures

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