GingivitisPhase 4NCT05731778
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
A Phase 4 study testing Stannous Fluoride Toothpaste and Colgate fluoride toothpaste in people with Gingivitis, run by Colgate Palmolive at 1 site in Canada.
Trial summary
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Stannous Fluoride Toothpaste and Colgate fluoride toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 22 Dec 2018to 22 Dec 2020
- Phase
- Phase 4
- 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 or female volunteers aged 18-70 years
- In good general health, ASA I
- No clinical signs of gingival inflammation at >90% sites observed
- Probing Depth (PD) < 3.0 mm
- Attachment Loss (AL) = 0 mm
- No periodontal disease history
- Non-smokers
- Fluent in English
Who cannot join
- Presence of orthodontic bands.
- Presence of partial removal dentures.
- Tumour(s) of the soft or the hard tissues of the oral cavity.
- Cavitated carious lesions requiring immediate restorative treatment.
- History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
- Participation in any other clinical study or test panel with a one month period prior to entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.
Read the detailed description
A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride Toothpaste, Colgate fluoride toothpaste
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride ToothpasteDrug
Also called Colgate Total SF
0.454% stannous fluoride toothpaste
Colgate fluoride toothpasteDrug
Also called Colgate Dental Cream
0.76 % Sodium MonoFluorophosphate (MFP)
| Study group | Role | What they receive |
|---|---|---|
| Stannous fluoride test toothpaste | Experimental | Currently marketed as the new Colgate Total SF containing Stannous Fluoride Receives: Drug: Stannous Fluoride Toothpaste |
| Colgate flouride toothpaste | Placebo comparator | Colgate Dental Cream containing Stannous Sodium Fluoride Receives: Drug: Colgate fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Index (BOP) and Oral Inflammatory Load
BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses
Measured: during patient visit over the 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start22 Dec 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Glogauer, DDS/PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731778
- Sponsor's protocol ID
- CRO-2018-07-IND-GING-DELAY-JG
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fine N, Barbour A, Kaura K, Kerns KA, Chen D, Trivedi HM, Gomez J, Sabharwal A, McLean JS, Darveau RP, Glogauer M. Effects of a stabilized stannous fluoride dentifrice on clinical, immunomodulatory, and microbial outcomes in a human experimental gingivitis model. J Periodontol. 2024 May;95(5):421-431. doi: 10.1002/JPER.22-0710. Epub 2023 Oct 27.
PubMed 37885337
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
- ClinicalTrials.gov ID
- NCT05731778
- Acronym / sponsor ID
- CRO-2018-07-IND-GING-DELAY-JG
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 16 Feb 2023 (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.
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.
Detailed description
A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stannous fluoride test toothpaste | Experimental | Drug: Stannous Fluoride ToothpasteCurrently marketed as the new Colgate Total SF containing Stannous Fluoride |
| Colgate flouride toothpaste | Placebo comparator | Drug: Colgate fluoride toothpasteColgate Dental Cream containing Stannous Sodium Fluoride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female volunteers aged 18-70 years
- In good general health, ASA I
- No clinical signs of gingival inflammation at >90% sites observed
- Probing Depth (PD) < 3.0 mm
- Attachment Loss (AL) = 0 mm
Key exclusion criteria (6 listed)
- Presence of orthodontic bands.
- Presence of partial removal dentures.
- Tumour(s) of the soft or the hard tissues of the oral cavity.
- Cavitated carious lesions requiring immediate restorative treatment.
- History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring 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 |
|---|---|---|
| Stannous Fluoride ToothpasteAlso: Colgate Total SF0.454% stannous fluoride toothpaste | Drug | Stannous fluoride test toothpaste |
| Colgate fluoride toothpasteAlso: Colgate Dental Cream0.76 % Sodium MonoFluorophosphate (MFP) | Drug | Colgate flouride toothpaste |
Primary outcome
Bleeding Index (BOP) and Oral Inflammatory Load
Time frame: during patient visit over the 9 weeks
BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses
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 16 Feb 2023.
- Derived from this study: PubMed 37885337Fine N, Barbour A, Kaura K, Kerns KA, Chen D, Trivedi HM, Gomez J, Sabharwal A, McLean JS, Darveau RP, Glogauer M. Effects of a stabilized stannous fluoride dentifrice on clinical, immunomodulatory, and microbial outcomes in a human experimental gingivitis model. J Periodontol. 2024 May;95(5):421-431. doi: 10.1002/JPER.22-0710. Epub 2023 Oct 27.
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.
Michael Glogauer, DDS/PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stannous Fluoride Toothpaste and Colgate fluoride toothpaste in people with Gingivitis, run by Colgate Palmolive at 1 site in Canada.
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 8 inclusion and 6 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 16 Feb 2023. 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 Canada. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Bleeding Index (BOP) and Oral Inflammatory Load (time frame: during patient visit over the 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731778, which also lists 1 linked publication.
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 16 Feb 2023.