Two-year clinical study on anticaries efficacy of novel dentifrice containing arginine and fluoride

Phase 3

Completed

• Conditions: Caries

• Registration Number: TCTR20130801001
• Lead Sponsor: Colgate-Palmolive Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-01-11
• Study Start: 2013-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Inclusion Characteristics:
-Children in elementary or middle school who have at least four permanent molars fully erupted, and at least one permanent central and/or lateral incisor erupted.
-Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study.

Exclusion Criteria

Exclusion Characteristics
-Presence of orthodontic appliances involving more than four permanent teeth.
-Any condition which, in the opinion of the Investigator, would hinder participation by the potential subject. The reason for any such exclusion shall be carefully documented by the Investigator.
-Participation in any other clinical study during the three -months preceding the clinical study.
-History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dental caries increment At Baseline, 1 year and 2 years DMFT, DMFS

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A