Calculus, DentalPhase 2/3NCT07223060
Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
A Phase 2/3 study testing 0.454% stannous fluoride and 0.76% sodium monofluorophosphate in people with Calculus, Dental, run by Colgate Palmolive at 1 site in Thailand.
Trial summary
To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Calculus, Dental
- What is being tested?
- 0.454% stannous fluoride and 0.76% sodium monofluorophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 17 May 2017to 6 Oct 2017
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects were required to sign an Informed Consent form
- Subjects had to be in general good health
- Male and female adults between the ages of 18-70 (inclusive)
- Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
- Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
- Subjects had to be able to participate for the full duration (20 weeks) of the study
Who cannot join
- Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer
- Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
- Moderate or advanced periodontal disease
- Five or more carious lesions requiring immediate care
- Use of antibiotics or steroids any time during one month prior to entry into the study
- Participation in any other clinical study or panel test
Show all 10Show fewer
- Pregnant or breast feeding women
- History of allergies to dentifrice and personal care ingredients
- Allergies to dentifrice products
- Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
M U International Oral Science Research, Ltd.
Bangkok, Bangkok, 10250
About this study
Official title: A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.
- Conditions
- Calculus, Dental
- Being tested
- 0.454% stannous fluoride, 0.76% sodium monofluorophosphate
- Medical subject headings
- Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454% stannous fluorideDrug
brushed twice daily, morning and evening for 2 minutes eact time
0.76% sodium monofluorophosphateDrug
brushed twice daily, morning and evening for 2 minutes eact time
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Not described Receives: Drug: 0.454% stannous fluoride |
| Test 2 toothpaste | Active comparator | Not described Receives: Drug: 0.76% sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supragingival calculus formation via Volpe-Manhold Calculus Index
index for comparing the amount of dental calculus
Measured: baseline and 12 week measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start17 May 2017
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculus, DentalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dutmanee Seriwatanachai, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223060
- Sponsor's protocol ID
- CRO-2017-04-TAR-SNDZ-YPZ
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
- ClinicalTrials.gov ID
- NCT07223060
- Acronym / sponsor ID
- CRO-2017-04-TAR-SNDZ-YPZ
- Conditions
- Calculus, Dental
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 31 Oct 2025 (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.
To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: 0.454% stannous fluoride |
| Test 2 toothpaste | Active comparator | Drug: 0.76% sodium monofluorophosphate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects were required to sign an Informed Consent form
- Subjects had to be in general good health
- Male and female adults between the ages of 18-70 (inclusive)
- Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
- Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
Key exclusion criteria (10 listed)
- Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer
- Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
- Moderate or advanced periodontal disease
- Five or more carious lesions requiring immediate care
- Use of antibiotics or steroids any time during one month prior to entry into the study
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 |
|---|---|---|
| 0.454% stannous fluoridebrushed twice daily, morning and evening for 2 minutes eact time | Drug | Test 1 toothpaste |
| 0.76% sodium monofluorophosphatebrushed twice daily, morning and evening for 2 minutes eact time | Drug | Test 2 toothpaste |
Primary outcome
Supragingival calculus formation via Volpe-Manhold Calculus Index
Time frame: baseline and 12 week measurement
index for comparing the amount of dental calculus
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 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Calculus, Dental
Not yet recruiting
Bio-Descaling Toothpaste for Dental Calculus Reduction
Dental Calculus, Gingivitis and Periodontal Diseases
Not yet recruitingObservational study
Evaluation of Occlusal Adjustment Material Removal on Monolithic Zirconia Blocks: An In Vitro Study
Dental Occlusion, Occlusal Wear of Teeth
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.
Dutmanee Seriwatanachai principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.454% stannous fluoride and 0.76% sodium monofluorophosphate in people with Calculus, Dental, run by Colgate Palmolive at 1 site in Thailand.
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 6 inclusion and 10 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Supragingival calculus formation via Volpe-Manhold Calculus Index (time frame: baseline and 12 week measurement). 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 11 Dec 2025.