Plaque, DentalPhase 3NCT06353165
Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva
A Phase 3 study testing Stannous fluoride toothpaste and Colgate Dental Cream in people with Plaque, Dental, run by Colgate Palmolive at 1 site in Thailand.
Trial summary
This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- Stannous fluoride toothpaste and Colgate Dental Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 8 Mar 2023to 12 Apr 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages 18-70, inclusive.
- Subject is available during study duration and has no allergies to oral hygiene formulations.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
- Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
Who cannot join
- Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- History of dental prophylaxis or treatments in the past month or during study duration.
- History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- Subjects scheduled for medical procedures for the duration of the study.
- Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
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- History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Oral soft tissue pathology.
- History of active or severe periodontal disease and loose teeth.
- Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
- Fixed or removable orthodontic appliance or removable partial dentures.
- Self-reported pregnancy or lactation.
- Subjects known to be an alcoholic, or a recovering alcoholic.
- History or current use of recreational drugs or other habit promoting products.
- Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
- Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled 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 Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste
This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.
- Conditions
- Plaque, Dental
- Being tested
- Stannous fluoride toothpaste, Colgate Dental Cream
- Keywords
- bacteria, plaque, saliva
- Medical subject headings
- Dental Plaque, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluoride toothpasteDrug
Also called experimental
product containing 0.45% stannous fluoride
Colgate Dental CreamDrug
Also called control
product containing 0.76% sodium monofluorophosphate
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | toothpaste brushing 2/day for 2 minutes Receives: Drug: Colgate Dental Cream |
| Group II | Experimental | toothpaste brushing 2/day for 2 minutes Receives: Drug: Stannous fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole mouth scores of dental plaque
Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more [Turesky Modification of plaque will be enrolled.
Quigley-Hein.
Measured: baseline, 2 week & 4 week
Measurement of total bacterial counts on tongue
Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measured: baseline, 2 week & 4 week
Measurement of total bacterial counts on cheek
Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measured: baseline, 2 week & 4 week
Measurement of gingivitis
Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis [Loe-Silness] will be enrolled.
Measured: baseline, 2 week & 4 week
Measurement of total bacterial counts in saliva
Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measured: baseline, 2 week & 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start8 Mar 2023
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- blinded
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353165
- Sponsor's protocol ID
- CRO-2022-12-BAC-SNF-THA-YPZ
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste
- ClinicalTrials.gov ID
- NCT06353165
- Acronym / sponsor ID
- CRO-2022-12-BAC-SNF-THA-YPZ
- Conditions
- Plaque, Dental
- Keywords
- bacteria, plaque, saliva
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 8 Apr 2024 (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.
This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- blinded
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Colgate Dental Creamtoothpaste brushing 2/day for 2 minutes |
| Group II | Experimental | Drug: Stannous fluoride toothpastetoothpaste brushing 2/day for 2 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects, ages 18-70, inclusive.
- Subject is available during study duration and has no allergies to oral hygiene formulations.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
- Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
Key exclusion criteria (17 listed)
- Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- History of dental prophylaxis or treatments in the past month or during study duration.
- History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- Subjects scheduled for medical procedures for the duration of the study.
- Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
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 |
|---|---|---|
| Stannous fluoride toothpasteAlso: experimentalproduct containing 0.45% stannous fluoride | Drug | Group II |
| Colgate Dental CreamAlso: controlproduct containing 0.76% sodium monofluorophosphate | Drug | Group I |
Primary outcome
Whole mouth scores of dental plaque
Time frame: baseline, 2 week & 4 week
Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more [Turesky Modification of plaque will be enrolled. Quigley-Hein.
Measurement of total bacterial counts on tongue
Time frame: baseline, 2 week & 4 week
Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of total bacterial counts on cheek
Time frame: baseline, 2 week & 4 week
Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of gingivitis
Time frame: baseline, 2 week & 4 week
Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis [Loe-Silness] will be enrolled.
Measurement of total bacterial counts in saliva
Time frame: baseline, 2 week & 4 week
Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
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 15 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stannous fluoride toothpaste and Colgate Dental Cream in people with Plaque, 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 5 inclusion and 17 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 15 Apr 2024. 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 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?
Whole mouth scores of dental plaque (time frame: baseline, 2 week & 4 week). The study lists 5 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 15 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.