Dental CariesPhase 3NCT05560945
2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste
A Phase 3 study testing 0.32% Sodium Fluoride Dentifrice Toothpaste, 1.5% Arginine Dentifrice and 8.0% Arginine Dentifrice in people with Dental Caries, run by Colgate Palmolive at 3 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 0.32% Sodium Fluoride Dentifrice Toothpaste, 1.5% Arginine Dentifrice and 8.0% Arginine Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 3 sitesChina
- Study dates
- 15 Apr 2019to 12 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China School of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
School of Stomatology Chongqing Medical University
Chongqing, 400016
School of Stomatology, Xian Jiaotong University
Xi'an, Shaanxi, 710004
About this study
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
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
- Conditions
- Dental Caries
- Being tested
- 0.32% Sodium Fluoride Dentifrice Toothpaste, 1.5% Arginine Dentifrice, 8.0% Arginine Dentifrice
- Keywords
- fluoride, prevention, caries, ICDAS, DMFS, arginine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.32% Sodium Fluoride Dentifrice ToothpasteDrug
Toothpaste
1.5% Arginine DentifriceDrug
Toothpaste
8.0% Arginine DentifriceDrug
Toothpaste
| Study group | Role | What they receive |
|---|---|---|
| 0.32% Sodium Fluoride Dentifrice Toothpaste | Active comparator | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study Receives: Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste |
| 1.5% Arginine Dentifrice Toothpaste | Experimental | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study Receives: Drug: 1.5% Arginine Dentifrice |
| 8.0% Arginine Dentifrice Toothpaste | Experimental | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study Receives: Drug: 8.0% Arginine Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use.
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Measured: 2 year
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use.
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start15 Apr 2019
- Primary completion12 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Po E Zhang, PhD, DDS(Hons), Study director, Colgate Palmolive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560945
- Sponsor's protocol ID
- CRO-2018-12-CAR-ARG-YPZ
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05560945
- Acronym / sponsor ID
- CRO-2018-12-CAR-ARG-YPZ
- Conditions
- Dental Caries
- Keywords
- fluoride, prevention, caries, ICDAS, DMFS, arginine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.32% Sodium Fluoride Dentifrice Toothpaste | Active comparator | Drug: 0.32% Sodium Fluoride Dentifrice ToothpasteWhole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
| 1.5% Arginine Dentifrice Toothpaste | Experimental | Drug: 1.5% Arginine DentifriceWhole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
| 8.0% Arginine Dentifrice Toothpaste | Experimental | Drug: 8.0% Arginine DentifriceWhole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.32% Sodium Fluoride Dentifrice ToothpasteToothpaste | Drug | 0.32% Sodium Fluoride Dentifrice Toothpaste |
| 1.5% Arginine DentifriceToothpaste | Drug | 1.5% Arginine Dentifrice Toothpaste |
| 8.0% Arginine DentifriceToothpaste | Drug | 8.0% Arginine Dentifrice Toothpaste |
Primary outcome
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use.
Time frame: 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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Po E Zhang, PhD, DDS(Hons) study director
Colgate Palmolive
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.32% Sodium Fluoride Dentifrice Toothpaste, 1.5% Arginine Dentifrice and 8.0% Arginine Dentifrice in people with Dental Caries, run by Colgate Palmolive at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use. (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.