Gingival DiseasesPhase 3NCT00966953
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
A Phase 3 study testing Fluoride, Triclosan/Fluoride toothpaste and antibacterial plant extract in people with Gingival Diseases, run by Colgate Palmolive at 1 site in United States.
Trial summary
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Fluoride, Triclosan/Fluoride toothpaste and antibacterial plant extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2008
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Who cannot join
- Medical condition which requires pre-medication prior to dental procedures/visits.
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients.
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
- Two or more decayed untreated dental sites at screening.
Show all 17Show fewer
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- Use of medications that can currently affect salivary flow.
- Current use of antibiotics.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Pregnant or nursing women.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- Use of tobacco products.
- Subjects who must receive dental treatment during the study dates.
- Current use of Antibiotics for any purpose.
- Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastman Dental Center - University of Rochester
Rochester, New York, 14642-8315
About this study
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
- Conditions
- Gingival Diseases
- Being tested
- Fluoride, Triclosan/Fluoride toothpaste, antibacterial plant extract
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Brush twice daily
Triclosan/Fluoride toothpasteDrug
Brush twice daily
FluorideDrug
Also called honokiol
Brush twice daily
FluorideDrug
Brush twice daily
antibacterial plant extractOther
Also called Honokiol
Brush twice daily
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Toothpaste | Placebo comparator | fluoride control Receives: Drug: Fluoride |
| Total/Whitening | Active comparator | positive control Receives: Drug: Triclosan/Fluoride toothpaste |
| antibacterial plant extract 1 | Experimental | Honokiol Receives: Drug: Fluoride |
| antibacterial plant extract 2 | Experimental | magnolol Receives: Drug: Fluoride; Other: antibacterial plant extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 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 Gingival DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yanfang Ren, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966953
- Sponsor's protocol ID
- ERO-0907-PLA-16-RR
- Status last verified
- Sep 2009
- First submitted
- 26 Sep 2008
- Last updated
- 22 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
- ClinicalTrials.gov ID
- NCT00966953
- Acronym / sponsor ID
- ERO-0907-PLA-16-RR
- Conditions
- Gingival Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 27 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluoride Toothpaste | Placebo comparator | Drug: Fluoridefluoride control |
| Total/Whitening | Active comparator | Drug: Triclosan/Fluoride toothpastepositive control |
| antibacterial plant extract 1 | Experimental | Drug: FluorideHonokiol |
| antibacterial plant extract 2 | Experimental | Drug: Fluoride, Other: antibacterial plant extractmagnolol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Key exclusion criteria (17 listed)
- Medical condition which requires pre-medication prior to dental procedures/visits.
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients.
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
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 |
|---|---|---|
| FluorideBrush twice daily | Drug | Fluoride Toothpaste |
| Triclosan/Fluoride toothpasteBrush twice daily | Drug | Total/Whitening |
| FluorideAlso: honokiolBrush twice daily | Drug | antibacterial plant extract 1 |
| FluorideBrush twice daily | Drug | antibacterial plant extract 2 |
| antibacterial plant extractAlso: HonokiolBrush twice daily | Other | antibacterial plant extract 2 |
Primary outcome
Plaque Index
Time frame: 8 weeks
Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- 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.
Yanfang Ren, 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 3 study testing Fluoride, Triclosan/Fluoride toothpaste and antibacterial plant extract in people with Gingival Diseases, 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 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 22 Sep 2009. 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 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?
Yes. Results are posted in the registry (first posted 27 Aug 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?
Plaque Index (time frame: 8 weeks). 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 22 Sep 2009.