GingivitisPhase 4NCT00762528
Compare Anti-inflammatory Dentifrices
A Phase 4 study testing Triclosan/Copolymer/fluoride toothpaste and Sodium monofluorophosphate toothpaste in people with Gingivitis, run by Colgate Palmolive at 1 site in United States.
Trial summary
Plaque induced gingivitis Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Triclosan/Copolymer/fluoride toothpaste and Sodium monofluorophosphate toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be adult males or females 18 to 60 years old
- Subjects must be able and willing to follow study procedures and instructions
- Subjects must have read, understood and signed an informed consent form
- Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
- Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
- Each subject must have at least four teeth with probing depths of 4-5 mm and at least 30% of sites bleeding to gentle probing
Who cannot join
- Subjects who have chronically used (i.e., two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
- Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
- Subjects with periodontitis as indicated by periodontal pocketing 6 mm at screening
- Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
- Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
- Subjects with orthodontic appliances or removable partial dentures
Show all 15Show fewer
- Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
- Subjects who currently smoke or who report using tobacco products within one year of screening.
- Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
- Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
- Female subjects who report being pregnant or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms)
- Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
- Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
- Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
- Medical condition which precludes not eating/drinking for approximately 8 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834
About this study
Plaque induced gingivitis
- Conditions
- Gingivitis
- Being tested
- Triclosan/Copolymer/fluoride toothpaste, Sodium monofluorophosphate toothpaste
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan/Copolymer/fluoride toothpasteDrug
Also called Toothpaste includes triclosan/fluoride/co-polymer (Total)
Twice daily usage
Sodium monofluorophosphate toothpasteDrug
Also called fluoride only toothpaste
Twice daily usage
| Study group | Role | What they receive |
|---|---|---|
| Total Toothpaste | Active comparator | Triclosan/Copolymer/fluoride toothpaste Receives: Drug: Triclosan/Copolymer/fluoride toothpaste |
| Fluoride toothpaste | Placebo comparator | sodium monofluorophosphate toothpaste Receives: Drug: Sodium monofluorophosphate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (GI)
Gingival Index(GI)recorded on scale of 0-3 detailed below:
0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed
Measured: 29 days
Prostaglandin E2 (PGE2)
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Measured: 29 days
Interleukin - 1 Beta (IL-ß)
Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Measured: 29 days
Interleukin-6 (IL-6)
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Measured: 29 days
Nuclear Factor Kappa B Ligand (RANK-L)
Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Measured: 29 days
8-iso-prostaglandinF2α (8-iso-PGF2α)
Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Measured: 29 days
Secondary outcomes (2)
Dental Plaque Index (PI)
measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.
Measured: 29 days
Bleeding on Probing (BOP)
Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara G Grossi, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762528
- Sponsor's protocol ID
- CRO-1107-INF-ECU-FP
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2008
- Last updated
- 10 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Anti-inflammatory Dentifrices
- ClinicalTrials.gov ID
- NCT00762528
- Acronym / sponsor ID
- CRO-1107-INF-ECU-FP
- Conditions
- Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 3 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Plaque induced gingivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Toothpaste | Active comparator | Drug: Triclosan/Copolymer/fluoride toothpasteTriclosan/Copolymer/fluoride toothpaste |
| Fluoride toothpaste | Placebo comparator | Drug: Sodium monofluorophosphate toothpastesodium monofluorophosphate toothpaste |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be adult males or females 18 to 60 years old
- Subjects must be able and willing to follow study procedures and instructions
- Subjects must have read, understood and signed an informed consent form
- Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
- Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
Key exclusion criteria (15 listed)
- Subjects who have chronically used (i.e., two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
- Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
- Subjects with periodontitis as indicated by periodontal pocketing 6 mm at screening
- Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
- Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
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 |
|---|---|---|
| Triclosan/Copolymer/fluoride toothpasteAlso: Toothpaste includes triclosan/fluoride/co-polymer (Total)Twice daily usage | Drug | Total Toothpaste |
| Sodium monofluorophosphate toothpasteAlso: fluoride only toothpasteTwice daily usage | Drug | Fluoride toothpaste |
Primary outcome
Gingival Index (GI)
Time frame: 29 days
Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed
Prostaglandin E2 (PGE2)
Time frame: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin - 1 Beta (IL-ß)
Time frame: 29 days
Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin-6 (IL-6)
Time frame: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Nuclear Factor Kappa B Ligand (RANK-L)
Time frame: 29 days
Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
8-iso-prostaglandinF2α (8-iso-PGF2α)
Time frame: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
2 secondary outcomes
Dental Plaque Index (PI)
Time frame: 29 days
Bleeding on Probing (BOP)
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sara G Grossi, DDS principal investigator
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 Triclosan/Copolymer/fluoride toothpaste and Sodium monofluorophosphate toothpaste in people with Gingivitis, 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 6 inclusion and 15 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 10 Sep 2015. 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. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gingival Index (GI) (time frame: 29 days). The study lists 6 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 10 Sep 2015.