To evaluate the effectiveness and acceptability of the fluoridated toothpaste to prevent plaque and gum diseases in children in the age group of 6 to 12 years

To evaluate the efficacy and acceptability of the fluoridated toothpaste in its anti-plaque and anti-gingivitis properties in a pediatric population in the age group of 6 to 12 years – A non- randomized active controlled clinical trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062692

Enrollment

300

Registered

2024-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Intervention1: Dentoshine toothpaste: Tooth paste to be used for brushing twice daily for 3 months Control Intervention1: Colgate toothpaste - standard commercially available: Tooth paste to be used

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with plaque score 1 Subjects with gingival scores 1 and 2 Subjects showing signs of mild marginal gingival inflammation Subjects parent or guardian who agree to comply with all study requirements and are able to follow the study directions.

Exclusion criteria

Exclusion criteria: gingival scores more than 2 orthodontic bands and five or more carious lesions History of allergies Subject on antibiotics Subject with five or more carious lesions requiring immediate restorative treatment

Design outcomes

Primary

Measure	Time frame
Changes in the plaque and gingival scores Changes in the clinical signs of gingival inflammation Changes in the clinical signs of gingival inflammation Timepoint: Plaque and gingival score to be assessed at 1 monthi.e at 1st followup 2 months i.e at2nd followup and 3 months i.e at 3rd followup	—

Secondary

Measure	Time frame
Understanding products acceptability through survey data pointsTimepoint: acceptability and tolerability to be assessed after 1 month	—

Countries

India

Contacts

Public ContactDr Ashok Dhoble

Indian Dental Association

ashokdhoble@ida.org.in9820094499

Outcome results