GingivitisPhase 3NCT06300866
Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste
A Phase 3 study testing Test in people with Gingivitis and Plaque, Dental, run by Colgate Palmolive at 1 site in United States.
Trial summary
The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque, Dental
- What is being tested?
- Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 8 Mar 2021
- 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
- Potential subjects must meet all of the following criteria
- Subjects, ages 18-70, inclusive
- Availability for the six-month duration of the clinical research study
- Good general health
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
- Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
- Signed Informed Consent Form
Who cannot join
- Presence of orthodontic appliances
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
- Five or more carious lesions requiring immediate restorative treatment
- Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
Show all 11Show fewer
- Dental prophylaxis during the past two weeks prior to baseline examinations
- History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
- History of alcohol and/or drug abuse
- Self-reported pregnancy and/or lactating subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Dentistry
Loma Linda, California, 92350
About this study
Official title: The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California
The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.
- Conditions
- Gingivitis, Plaque, Dental
- Being tested
- Test, Control
- Keywords
- Loe and Silness Gingival Index, Quigley and Hein Plaque Index
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestDrug
test toothpaste containing 0.45% stannous fluoride
ControlDrug
toothpaste containing 0.76% sodium monofluorophosphate
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | toothpaste brushing 2x daily morning \& evening for 2 minutes Receives: Drug: Test; Drug: Control |
| Group II | Active comparator | toothpaste brushing 2x daily morning \& evening for 2 minutes Receives: Drug: Test; Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Mouth Gingivitis Measurement
difference of reduction in gingival index
Measured: baseline, 3 months and 6 months
Whole-Mouth Dental Plaque Measurement
difference of reduction in plaque index
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start18 Aug 2020
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiming Li, DDS MSD PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300866
- Sponsor's protocol ID
- CRO-2020-04-PGN-LLU-YPZ
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California
- ClinicalTrials.gov ID
- NCT06300866
- Acronym / sponsor ID
- CRO-2020-04-PGN-LLU-YPZ
- Conditions
- Gingivitis, Plaque, Dental
- Keywords
- Loe and Silness Gingival Index, Quigley and Hein Plaque Index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 8 Mar 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.
The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Test, Drug: Controltoothpaste brushing 2x daily morning \& evening for 2 minutes |
| Group II | Active comparator | Drug: Test, Drug: Controltoothpaste brushing 2x daily morning \& evening for 2 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Potential subjects must meet all of the following criteria
- Subjects, ages 18-70, inclusive
- Availability for the six-month duration of the clinical research study
- Good general health
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
Key exclusion criteria (11 listed)
- Presence of orthodontic appliances
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
- Five or more carious lesions requiring immediate restorative treatment
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 |
|---|---|---|
| Testtest toothpaste containing 0.45% stannous fluoride | Drug | Group I, Group II |
| Controltoothpaste containing 0.76% sodium monofluorophosphate | Drug | Group I, Group II |
Primary outcome
Whole-Mouth Gingivitis Measurement
Time frame: baseline, 3 months and 6 months
difference of reduction in gingival index
Whole-Mouth Dental Plaque Measurement
Time frame: baseline, 3 months and 6 months
difference of reduction in plaque index
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 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Yiming Li, DDS MSD PhD principal investigator
Loma Linda University
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 Test in people with Gingivitis and Plaque, Dental, run by Colgate Palmolive at 1 site in United States.
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 7 inclusion and 11 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 8 Mar 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 United States. 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 Gingivitis Measurement (time frame: baseline, 3 months and 6 months). 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 8 Mar 2024.