Dental PlaquePhase 3NCT00926029
Compare the Clinical Efficacy of Prototype Toothpastes
A Phase 3 study testing Fluoride, Triclosan, fluoride and Metal salt in people with Dental Plaque, run by Colgate Palmolive at 1 site in United States.
Trial summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Fluoride, Triclosan, fluoride and Metal salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 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.
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
- 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
- Subject unable or unwilling to sign the informed consent form.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- Moderate or advanced periodontal disease.
- 5 or more decayed untreated dental sites at screening.
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
Show all 17Show fewer
- Use of medications that currently affect salivary flow.
- 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 1 week 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.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients.
- History of allergy to zinc.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Concordia Clinical Research
Cedar Knolls, New Jersey, 07927
About this study
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
- Conditions
- Dental Plaque
- Being tested
- Fluoride, Triclosan, fluoride, Metal salt
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Also called Colgate Winterfresh Gel
Brush twice daily
Triclosan, fluorideDrug
Also called Colgate Total toothpaste
Brush twice daily
Metal saltOther
Also called New toothpaste formula being evaluated.
Brush twice daily
| Study group | Role | What they receive |
|---|---|---|
| Fluoride control -A | Placebo comparator | Winterfresh Gel Receives: Drug: Fluoride |
| Triclosan/Fluoride - B | Active comparator | Positive control (Total toothpaste) Receives: Drug: Triclosan, fluoride |
| Triclosan/fluoride/metal salt- C | Experimental | test toothpaste Receives: Other: Metal salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Plaque Index score 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: 6 weeks
Gingivitis Index
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 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 Dental PlaqueStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salim A Nathoo, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926029
- Sponsor's protocol ID
- CRO-2007-GIN-06-RR
- Status last verified
- Jun 2011
- First submitted
- 26 Sep 2008
- Last updated
- 17 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Clinical Efficacy of Prototype Toothpastes
- ClinicalTrials.gov ID
- NCT00926029
- Acronym / sponsor ID
- CRO-2007-GIN-06-RR
- Conditions
- Dental Plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 23 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride control -A | Placebo comparator | Drug: FluorideWinterfresh Gel |
| Triclosan/Fluoride - B | Active comparator | Drug: Triclosan, fluoridePositive control (Total toothpaste) |
| Triclosan/fluoride/metal salt- C | Experimental | Other: Metal salttest toothpaste |
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.
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
- 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)
- Subject unable or unwilling to sign the informed consent form.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- Moderate or advanced periodontal disease.
- 5 or more decayed untreated dental sites at screening.
- Other disease of the hard or soft oral tissues.
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 |
|---|---|---|
| FluorideAlso: Colgate Winterfresh GelBrush twice daily | Drug | Fluoride control -A |
| Triclosan, fluorideAlso: Colgate Total toothpasteBrush twice daily | Drug | Triclosan/Fluoride - B |
| Metal saltAlso: New toothpaste formula being evaluated.Brush twice daily | Other | Triclosan/fluoride/metal salt- C |
Primary outcome
Plaque Index
Time frame: 6 weeks
Plaque Index score 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)
Gingivitis Index
Time frame: 6 Weeks
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dental Plaque
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 recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
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.
Salim A Nathoo, 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 and Metal salt in people with Dental Plaque, 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 17 Feb 2012. 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 23 Jun 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: 6 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 17 Feb 2012.