GingivitisPhase 4NCT00941668
Evaluate Inflammation Caused by Gingivitis in Adults
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
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice 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
- Jan 2007to Aug 2008
- 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 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 millimeters and at least 30% of sites bleeding to gentle probing
Who cannot join
- Subjects who have chronically used (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 millimeters 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
- 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
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
- 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 Total toothpaste
Twice daily usage
sodium monofluorophosphate toothpasteDrug
Also called Colgate cavity protection 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.
Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Measured: 4 weeks
Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionAug 2008
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
- David Paquette, DMD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941668
- Sponsor's protocol ID
- CRO-1005-INF-UNC-FP
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2008
- Last updated
- 27 Aug 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 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Inflammation Caused by Gingivitis in Adults
- ClinicalTrials.gov ID
- NCT00941668
- Acronym / sponsor ID
- CRO-1005-INF-UNC-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
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Posted 17 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
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 (5 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 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 millimeters and at least 30% of sites bleeding to gentle probing
Key exclusion criteria (15 listed)
- Subjects who have chronically used (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 millimeters 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: Total toothpasteTwice daily usage | Drug | Total Toothpaste |
| sodium monofluorophosphate toothpasteAlso: Colgate cavity protection toothpasteTwice daily usage | Drug | Fluoride toothpaste |
Primary outcome
Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
Time frame: 4 weeks
Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
Time frame: 4 weeks
Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gingivitis
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
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.
David Paquette, DMD 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 5 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 27 Aug 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 17 Jul 2009). 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?
Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours (time frame: 4 weeks). 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 27 Aug 2015.