Clinical trial NCT05560945: 2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste
Official title: Clinical Investigation Examining the Anticaries Efficacy of 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): a Two-year Caries Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: fluoride
prevention
caries
ICDAS
DMFS
arginine
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use.
timeFrame: 2 year
measure: The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: School of Stomatology, Xian Jiaotong University
state: Shaanxi
city: Chengdu
country: China
facility: West China School of Stomatology, Sichuan University
state: Sichuan
city: Chongqing
country: China
facility: School of Stomatology Chongqing Medical University
Study officials:
affiliation: Colgate Palmolive
name: Yun Po E Zhang, PhD, DDS(Hons)
role: STUDY_DIRECTOR
References: