Dental Caries
Conditions
Keywords
fluoride, prevention, caries, ICDAS, DMFS, arginine
Brief summary
The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study
Interventions
Toothpaste
Toothpaste
Toothpaste
Sponsors
Study design
Eligibility
Inclusion criteria
* Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study * Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial. * Children ages 10-14 years at baseline. * Presence of second molars or evidence of erupting permanent molars. * Subjects should be of good general health as evidenced by a review of the medical history. * Presence of two or more active caries lesions (ICDAS scores of 2 or greater) and with a previous caries experience (DMFS ≥ 2). Exclusion Characteristics * Subjects presenting with any of the criteria below will be excluded from the study: * Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth. * Use of medication that could increase the risk of developing dental caries, i.e. medication that reduces saliva flow. * Long-term antibiotic therapy. * Children with cognitive and/or motor impairment. * Severe malocclusion. * Presence of severe caries (ICDAS 5 or 6) on five or more teeth. * Evidence of moderate to severe periodontal disease. * Participation in any other clinical study within the 30 days preceding the clinical study. * History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. * Pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use. | 2 year | the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome |
| The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use. | 2 year | the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome |
Countries
China